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Safety & Immunogenicity of Pneumococcal Vaccine 2189242A Co-administered With DTPa-HBV-IPV/Hib in Healthy Infants

Sponsor
GlaxoSmithKline (Industry)
Overall Status
Completed
CT.gov ID
NCT01204658
Collaborator
(none)
576
Enrollment
24
Locations
4
Arms
24.1
Actual Duration (Months)
24
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the safety, reactogenicity and immunogenicity of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age and co-administered with DTPa-HBV-IPV/Hib vaccine.

Condition or Disease Intervention/Treatment Phase
  • Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
  • Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
  • Biological: Synflorix
  • Biological: Prevenar 13
  • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
 Phase 2

Detailed Description

This study will assess the safety, reactogenicity, immunogenicity and persistence of two formulations of GSK Biologicals' pneumococcal vaccine 2189242A [high dose (HD) or low dose (LD)] given as a 3-dose primary vaccination course during the first 6 months of life followed by a booster dose at 12-15 months of age when co-administered with Infanrix hexa™ and compared to the vaccination with Synflorix™ and with Prevnar 13™ similarly co-administered with the Infanrix hexa™ vaccine.

Study Design

Study Type:
Interventional
Actual Enrollment :
576 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Safety, Reactogenicity & Immunogenicity of GSK Biologicals' Pneumococcal Vaccine 2189242A When Co-administered With DTPa-HBV-IPV/Hib Vaccine in Healthy Infants
Actual Study Start Date :
Sep 27, 2010
Actual Primary Completion Date :
Nov 3, 2011
Actual Study Completion Date :
Oct 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: 10PP-LD/Infanrix hexa Group

This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

Biological: Pneumococcal vaccine GSK 2189242A (LD formulation 1)
Intramuscular injection
Other Names:
  • GSK 2189242A; 10PP-LD

    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
    Intramuscular injection
    Experimental: 10PP-HD/Infanrix hexa Group

    This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.

    Biological: Pneumococcal vaccine GSK 2189242A (HD formulation 2)
    Intramuscular injection
    Other Names:
  • GSK 2189242A; 10PP-HD

    • Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
    Intramuscular injection
    Active Comparator: Synflorix/Infanrix hexa Group

    This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.

    Biological: Synflorix
    Intramuscular injection

    Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
    Intramuscular injection
    Active Comparator: Prevnar 13/Infanrix hexa Group

    This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.

    Biological: Prevenar 13
    Intramuscular injection

    Biological: Infanrix Hexa (DTPa-HBV-IPV/Hib)
    Intramuscular injection

    Outcome Measures

    Primary Outcome Measures

    1. Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study [Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course]

      Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).

    2. Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group [During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses]

      Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.

    3. Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group [During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses]

      Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.

    Secondary Outcome Measures

    1. Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.

    2. Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.

    3. Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.

    4. Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.

    5. Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.

    6. Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.

    7. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.

    8. Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.

    9. Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.

    10. Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.

    11. Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.

    12. Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.

    13. Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.

    14. Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.

    15. Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.

    16. Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. * A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.

    17. Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.

    18. Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.

    19. Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study [At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.

    20. Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study [At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)]

      Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.

    21. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study [Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course]

      Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).

    22. Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study [Within the 7-day (Days 0-6) period after booster vaccination]

      Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).

    23. Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study [Within the 7-day (Days 0-6) period post vaccination after booster vaccination]

      Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.

    24. Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study [Within the 31-day (Days 0-30) period post primary vaccination, across doses]

      An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

    25. Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study [Within the 31-day (Days 0-30) period post booster vaccination]

      An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.

    26. Number of Subjects With Serious Adverse Events (SAEs) [During the entire study period (Months 0-11)]

      An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Weeks to 14 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol

    • Male or female between, and including, 6 and 14 weeks (42-104 days) of age at the time of the first vaccination.

    • Written informed consent obtained from the parents/LAR(s) of the subject.

    • Healthy subjects as established by medical history and clinical examination before entering into the study.

    • Born after a gestation period of 36 to 42 weeks inclusive.

    Exclusion Criteria:

    • Child in care.

    • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.

    • Chronic administration of immunosuppressants or other immune-modifying drugs since birth.

    • Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s), with the exception of licensed flu vaccines.

    • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

    • Previous vaccination against S. pneumoniae since birth.

    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).

    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.

    • A family history of congenital or hereditary immunodeficiency.

    • Major congenital defects or any chronic illness.

    • History of any neurologic disorders or seizures.

    • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature >= 38.0°C on rectal setting or >= 37.5°C on oral or axillary setting.

    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.

    • Administration of immunoglobulins and/ or any blood products since birth or planned administration during the primary epoch and during the period starting three months before booster vaccination and ending one month after the booster vaccination.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 GSK Investigational Site Benesov Czechia 256 01
    2 GSK Investigational Site Brno Czechia 613 00
    3 GSK Investigational Site Decin Czechia 405 01
    4 GSK Investigational Site Jindrichuv Hradec Czechia 37701
    5 GSK Investigational Site Kladno Czechia 272 01
    6 GSK Investigational Site Liberec Czechia 46015
    7 GSK Investigational Site Nachod Czechia 547 01
    8 GSK Investigational Site Ostrov Czechia 363 01
    9 GSK Investigational Site Pardubice Czechia 532 03
    10 GSK Investigational Site Praha 6 Czechia 1600
    11 GSK Investigational Site Schwäbisch-Hall Baden-Wuerttemberg Germany 74523
    12 GSK Investigational Site Tuttlingen Baden-Wuerttemberg Germany 78532
    13 GSK Investigational Site Detmold Nordrhein-Westfalen Germany 32756
    14 GSK Investigational Site Frankenthal Rheinland-Pfalz Germany 67227
    15 GSK Investigational Site Berlin Germany 13055
    16 GSK Investigational Site Debica Poland 39-200
    17 GSK Investigational Site Krakow Poland 31-503
    18 GSK Investigational Site Poznan Poland 61-709
    19 GSK Investigational Site Siemianowice Slaskie Poland 41-103
    20 GSK Investigational Site Warszawa Poland 01-184
    21 GSK Investigational Site Wroclaw Poland 50345
    22 GSK Investigational Site Umeå Sweden SE-901 85
    23 GSK Investigational Site Örebro Sweden SE-702 11
    24 GSK Investigational Site Östersund Sweden SE-831 83

    Sponsors and Collaborators

    • GlaxoSmithKline

    Investigators

    • Study Director: GSK Clinical Trials, GlaxoSmithKline

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT01204658
    Other Study ID Numbers:
    • 113994
    • 2010-019730-27
    First Posted:
    Sep 17, 2010
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by GlaxoSmithKline
    Haemophilus influenzae
    Streptococcus pneumoniae
    immunogenicity
    Pneumococcal vaccine
    infants
    safety
    Additional relevant MeSH terms:
    Streptococcal Infections
    Vaccines
    Heptavalent Pneumococcal Conjugate Vaccine

    Study Results

    Participant Flow

    Recruitment Details A total of 576 subjects were initially enrolled in the study. Of these, one subject was older than protocol defined age range for the first vaccination, and therefore did not receive any vaccination.
    Pre-assignment Detail The study duration is approximately 10 to 14 months depending on age at recruitment and age at booster vaccination. 2 Phases in the study: Primary Phase when subjects received a 3-dose of pneumococcal vaccine co-administered with Infanrix hexa™ (Months 0, 1, 2), and Booster Phase when subjects received one dose of the same vaccines (Month 10).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Period Title: Primary Phase
    STARTED 146 142 145 142
    COMPLETED 146 142 144 142
    NOT COMPLETED 0 0 1 0
    Period Title: Primary Phase
    STARTED 144 140 140 140
    COMPLETED 144 140 140 140
    NOT COMPLETED 0 0 0 0

    Baseline Characteristics

    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group Total
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™. Total of all reporting groups
    Overall Participants 146 142 145 142 575
    Age (Weeks) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Weeks]
    10.3
    (2.49)
    10.1
    (2.70)
    10.1
    (2.61)
    10.2
    (2.64)
    10.2
    (2.61)
    Sex: Female, Male (Count of Participants)
    Female
    65
    44.5%
    67
    47.2%
    70
    48.3%
    66
    46.5%
    268
    46.6%
    Male
    81
    55.5%
    75
    52.8%
    75
    51.7%
    76
    53.5%
    307
    53.4%

    Outcome Measures

    1. Primary Outcome
    Title Number of Subjects With Any and Grade 3 Solicited General Symptoms and With Solicited General Symptoms Related to Vaccination - Primary Phase of the Study
    Description Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than or equal to [>=] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigators as causally related to vaccination. Grade 3 (G3) Drowsiness = Drowsiness that prevented normal activity. G3 Irritability = Crying that could not be comforted/prevented normal activity. G3 Loss of appetite = Subject did not eat at all. G3 Fever = Rectal temperature higher than (>) 40.0°C. Primary results correspond to results for occurrences of G3 fever symptoms assessed by the investigators as related to vaccination (Related G3 fever).
    Time Frame Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 146 142 144 142
    Any Drowsiness, post D1
    82
    56.2%
    76
    53.5%
    72
    49.7%
    77
    54.2%
    G3 Drowsiness, post D1
    4
    2.7%
    0
    0%
    2
    1.4%
    2
    1.4%
    Related Drowsiness, post D1
    63
    43.2%
    58
    40.8%
    52
    35.9%
    58
    40.8%
    Any Irritability, post D1
    93
    63.7%
    82
    57.7%
    89
    61.4%
    82
    57.7%
    G3 Irritability, post D1
    6
    4.1%
    9
    6.3%
    9
    6.2%
    5
    3.5%
    Related Irritability, post D1
    70
    47.9%
    62
    43.7%
    66
    45.5%
    57
    40.1%
    Any Loss Appet., post D1
    38
    26%
    32
    22.5%
    39
    26.9%
    32
    22.5%
    G3 Loss Appet., post D1
    0
    0%
    1
    0.7%
    0
    0%
    0
    0%
    Related Loss Appet., post D1
    28
    19.2%
    26
    18.3%
    29
    20%
    21
    14.8%
    Any Fever, post D1
    45
    30.8%
    32
    22.5%
    53
    36.6%
    28
    19.7%
    G3 Fever, post D1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever, post D1
    33
    22.6%
    25
    17.6%
    44
    30.3%
    27
    19%
    Related G3 Fever, post D1
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Drowsiness, post D2
    71
    48.6%
    63
    44.4%
    70
    48.3%
    66
    46.5%
    G3 Drowsiness, post D2
    4
    2.7%
    2
    1.4%
    1
    0.7%
    1
    0.7%
    Related Drowsiness, post D2
    53
    36.3%
    49
    34.5%
    56
    38.6%
    55
    38.7%
    Any Irritability, post D2
    88
    60.3%
    81
    57%
    86
    59.3%
    87
    61.3%
    G3 Irritability, post D2
    8
    5.5%
    3
    2.1%
    5
    3.4%
    6
    4.2%
    Related Irritability, post D2
    69
    47.3%
    66
    46.5%
    66
    45.5%
    67
    47.2%
    Any Loss Appet., post D2
    32
    21.9%
    30
    21.1%
    28
    19.3%
    30
    21.1%
    G3 Loss Appet., post D2
    1
    0.7%
    2
    1.4%
    0
    0%
    0
    0%
    Related Loss Appet., post D2
    23
    15.8%
    21
    14.8%
    18
    12.4%
    25
    17.6%
    Any Fever, post D2
    40
    27.4%
    50
    35.2%
    38
    26.2%
    38
    26.8%
    G3 Fever, post D2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever, post D2
    32
    21.9%
    39
    27.5%
    33
    22.8%
    31
    21.8%
    Related G3 Fever, post D2
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Any Drowsiness, post D3
    57
    39%
    48
    33.8%
    56
    38.6%
    48
    33.8%
    Grade 3 Drowsiness, post D3
    2
    1.4%
    0
    0%
    1
    0.7%
    1
    0.7%
    Related Drowsiness, post D3
    51
    34.9%
    38
    26.8%
    44
    30.3%
    36
    25.4%
    Any Irritability, post D3
    62
    42.5%
    73
    51.4%
    62
    42.8%
    72
    50.7%
    G3 Irritability, post D3
    7
    4.8%
    1
    0.7%
    3
    2.1%
    2
    1.4%
    Related Irritability, post D3
    52
    35.6%
    55
    38.7%
    48
    33.1%
    53
    37.3%
    Any Loss Appet., post D3
    28
    19.2%
    25
    17.6%
    24
    16.6%
    21
    14.8%
    G3 Loss Appet., post D3
    0
    0%
    0
    0%
    2
    1.4%
    2
    1.4%
    Related Loss Appet., post D3
    22
    15.1%
    20
    14.1%
    18
    12.4%
    13
    9.2%
    Any Fever, post D3
    28
    19.2%
    23
    16.2%
    27
    18.6%
    30
    21.1%
    G3 Fever, post D3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Related Fever, post D3
    23
    15.8%
    19
    13.4%
    20
    13.8%
    22
    15.5%
    Related G3 Fever, post D3
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    2. Primary Outcome
    Title Percentage of Subjects Reporting Fever > 40.0°C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in 10PP-LD/Infanrix Hexa Group and in Synflorix/Infanrix Hexa Group
    Description Grade 3 fever was defined as fever by rectal measurement > 40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-LD/Infanrix hexa (or 10PP-LD) and Synflorix/Infanrix hexa (or 10PN) groups only.
    Time Frame During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
    Measure Participants 146 144
    Fever>40.0°C & Related Dose 1
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related Dose 2
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related Dose 3
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related across doses
    0.0
    0%
    0.0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-LD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-LD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-LD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.62 to 2.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-LD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-LD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-LD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.57
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Primary Outcome
    Title Percentage of Subjects Reporting Fever > 40° C With Causal Relationship to Vaccination After Each Primary Vaccination Dose and Across Doses in the 10PP-HD/Infanrix Hexa Group and in the Synflorix/Infanrix Hexa Group
    Description Grade 3 fever was defined as fever by rectal measurement >40.0°C. Related was defined as causal relationship to vaccination. This endpoint was assessed after each primary vaccination dose and across doses and in subjects in the 10PP-HD/Infanrix hexa (or 10PP-HD) and Synflorix/Infanrix hexa (or 10PN) groups only.
    Time Frame During the 7-day (Days 0-6) post-vaccination period following each primary vaccination dose and across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
    Measure Participants 142 144
    Fever>40.0°C & Related Dose 1
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related Dose 2
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related Dose 3
    0.0
    0%
    0.0
    0%
    Fever>40.0°C & Related across doses
    0.0
    0%
    0.0
    0%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 1 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 1 vaccination in the 10PP-HD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 2 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 2 vaccination in the 10PP-HD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine post dose 3 was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to dose 3 vaccination in the 10PP-HD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.63 to 2.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection 10PP-LD/Infanrix Hexa Group, 10PP-HD/Infanrix Hexa Group
    Comments Non-inferiority of 10PP-HD vaccine vs Synflorix™ vaccine across doses was assessed by computing the difference in percentages of subjects reporting Grade 3 fever causally related to vaccination, across doses, in the 10PP-HD Group minus Synflorix Group.
    Type of Statistical Test Non-Inferiority or Equivalence
    Comments Non-inferiority was supported if one could rule out an increase in terms of percentage of subjects (10PP-HD Group minus Synflorix Group) above 5% + half the incidence in the Synflorix Group (= null hypothesis) as shown by a 1-sided P-value < 5%.
    Statistical Test of Hypothesis p-Value 0.003
    Comments 1-sided P-value computed using Kem Philips' approach for ruling out an increase in % subjects with fever > 40.0°C and causal relationship to vaccination > the boundary expressed as 5% + 0.5*rate in the Synflorix group.
    Method Kem Phillip's statistical test
    Comments
    Method of Estimation Estimation Parameter Difference in percentage
    Estimated Value 0
    Confidence Interval (2-Sided) 95%
    -2.61 to 2.64
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    4. Secondary Outcome
    Title Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Primary Phase of the Study
    Description Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 130 134 136 131
    Anti-dPly - At Month 3
    9408.42
    12137.96
    459.97
    472.88
    Anti-PhtD - At Month 3
    1456.57
    1996.61
    523.61
    552.01
    5. Secondary Outcome
    Title Antibody Concentrations Against Pneumococcal Pneumolysin Toxoid (dPly) and Pneumococcal Histidine Triad Protein D (PhtD) Proteins - Booster Phase of the Study
    Description Antibody concentrations against dPly and PhtD (anti-dPly and anti-PhtD, respectively) were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). Cut-offs for seropositivity were concentrations higher than or equal to (≥)12 EL.U/mL for anti-dPly antibodies and ≥ 17 EL.U/mL for anti-PhtD antibodies. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 130 129 129 129
    Anti-dPly - Month 10
    6674.42
    5592.85
    495.02
    737.71
    Anti-dPly - Month 11
    24720.40
    29838.18
    582.85
    791.42
    Anti-PhtD - Month 10
    910.80
    829.12
    209.27
    381.66
    Anti-PhtD - Month 11
    3528.25
    3777.39
    266.58
    469.16
    6. Secondary Outcome
    Title Antibody Concentrations Against Protein D (Anti-PD) - Primary Phase of the Study
    Description Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 132 134 137 132
    Geometric Mean (95% Confidence Interval) [EL.U/mL]
    1135.7
    1323.3
    1539.0
    147.0
    7. Secondary Outcome
    Title Antibody Concentrations Against Protein D (Anti-PD) - Booster Phase of the Study
    Description Antibody concentrations were measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in ELISA Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was a concentration of anti-PD antibodies ≥ 100 EL.U/mL. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 131 130 131 129
    Anti-PD - Month 10
    434.3
    472.8
    698.2
    81.0
    Anti-PD - Month 11
    1655.4
    1631.0
    2394.2
    85.7
    8. Secondary Outcome
    Title Antibody Concentrations Against Pneumococcal Serotypes - Primary Phase of the Study
    Description Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration ≥ 0.05 µg/mL. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 132 135 137 132
    ANTI-1 At Month 3
    1.57
    1.58
    1.49
    2.20
    ANTI-4 At Month 3
    2.04
    2.11
    1.82
    2.43
    ANTI-5 At Month 3
    2.46
    2.55
    2.31
    2.77
    ANTI-6B At Month 3
    0.36
    0.37
    0.40
    0.46
    ANTI-7F At Month 3
    2.12
    2.21
    2.20
    2.94
    ANTI-9V At Month 3
    1.83
    1.95
    1.99
    2.33
    ANTI-14 At Month 3
    3.57
    3.72
    3.91
    4.18
    ANTI-18C At Month 3
    2.27
    2.18
    2.45
    2.56
    ANTI-19F At Month 3
    4.29
    4.13
    4.51
    3.50
    ANTI-23F At Month 3
    0.67
    0.62
    0.67
    1.48
    ANTI-3 (At Month 3
    0.05
    0.06
    0.05
    2.47
    ANTI-6A At Month 3
    0.13
    0.11
    0.11
    2.05
    ANTI-19A At Month 3
    0.18
    0.17
    0.16
    2.77
    9. Secondary Outcome
    Title Antibody Concentrations Against Pneumococcal Serotypes - Booster Phase of the Study
    Description Antibodies assessed for this outcome measure were those against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (ANTI-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). Antibody concentrations were measured by 22F enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs), in micrograms per milliliter (µg/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.05 µg/mL. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study vaccine component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 130 131 131 129
    ANTI-1 Month 10
    0.30
    0.30
    0.26
    0.49
    ANTI-1 Month 11
    2.62
    2.61
    2.41
    3.78
    ANTI-4 Month 10
    0.50
    0.51
    0.58
    0.40
    ANTI-4 Month 11
    4.10
    3.90
    3.98
    4.36
    ANTI-5 Month 10
    0.59
    0.58
    0.55
    0.85
    ANTI-5 Month 11
    3.48
    3.44
    3.33
    7.52
    ANTI-6B Month 10
    0.45
    0.47
    0.46
    0.25
    ANTI-6B Month 11
    2.04
    1.96
    2.28
    3.11
    ANTI-7F Month 10
    0.94
    1.00
    0.98
    1.34
    ANTI-7F Month 11
    4.72
    4.70
    4.87
    7.68
    ANTI-9V Month 10
    0.77
    0.97
    0.99
    0.58
    ANTI-9V Month 11
    4.48
    4.91
    5.20
    6.57
    ANTI-14 Month 10
    1.36
    1.43
    1.57
    2.06
    ANTI-14 Month 11
    6.06
    7.18
    6.63
    11.43
    ANTI-18C Month 10
    0.75
    0.76
    0.92
    0.75
    ANTI-18C Month 11
    6.68
    6.38
    7.65
    6.40
    ANTI-19F Month 10
    1.25
    1.13
    1.30
    0.66
    ANTI-19F Month 11
    6.73
    7.22
    7.84
    7.43
    ANTI-23F Month 10
    0.46
    0.47
    0.57
    0.37
    ANTI-23F Month 11
    3.20
    3.20
    3.72
    7.10
    ANTI-3 Month 10
    0.05
    0.05
    0.05
    0.32
    ANTI-3 Month 11
    0.06
    0.05
    0.06
    1.83
    ANTI-6A Month 10
    0.19
    0.18
    0.20
    0.70
    ANTI-6A Month 11
    0.89
    0.74
    0.99
    7.77
    ANTI-19A Month 10
    0.18
    0.15
    0.18
    0.57
    ANTI-19A Month 11
    1.12
    1.03
    1.23
    7.77
    10. Secondary Outcome
    Title Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Primary Phase of the Study
    Description Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 63 57 66 63
    OPA-1 At Month 3
    38.6
    27.8
    29.4
    68.9
    OPA-4 At Month 3
    703.7
    844.4
    819.2
    748.1
    OPA-5 At Month 3
    47.3
    60.6
    50.3
    72.9
    OPA-6B At Month 3
    399.6
    454.7
    409.7
    884.9
    OPA-7F At Month 3
    3212.6
    3697.6
    4234.2
    7394.5
    OPA-9V At Month 3
    1942.4
    1520.7
    1983.6
    2242.8
    OPA-14 At Month 3
    1405.3
    1334.9
    1575.3
    2410.6
    OPA-18C At Month 3
    108.1
    102.7
    169.4
    257.6
    OPA-19F At Month 3
    211.6
    344.1
    381.6
    142.5
    OPA-23F At Month 3
    1275.6
    2170.3
    1757.9
    4437.1
    OPA-3 (At Month 3
    5.0
    4.5
    4.6
    88.4
    OPA-6A At Month 3
    43.2
    59.6
    44.7
    1726.0
    OPA-19A At Month 3
    576.0
    914.6
    905.2
    2915.3
    11. Secondary Outcome
    Title Titers for Opsonophagocytic Activity Against Pneumococcal Serotypes - Booster Phase of the Study
    Description Titers for opsonophagocytic activity assessed for this outcome measure were those for opsonophagocytic activity against the vaccine/cross-reactive pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F (OPA-1, -3, -4, -5, -6A, -6B, -7F, -9V, -14, -18C, -19A, -19F and -23F). The Seropositivity cut-off of the assay was a titer for opsonophagocytic activity higher than or equal to (≥) 8, except for the OPA-19A for which the titer was ≥ to the serotype-specific Lower Limit of Quantification (=143). This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 68 58 68 62
    OPA-1 Month 10
    12.4
    13.2
    18.7
    10.3
    OPA-1 Month 11
    373.5
    369.2
    300.0
    369.3
    OPA-4 Month 10
    36.2
    48.3
    122.3
    18.5
    OPA-4 Month 11
    1370.7
    1634.8
    2043.3
    2882.6
    OPA-5 Month 10
    9.3
    10.5
    9.5
    8.7
    OPA-5 Month 11
    154.5
    166.8
    139.3
    327.4
    OPA-6B Month 10
    103.2
    174.5
    136.9
    113.8
    OPA-6B Month 11
    802.1
    700.3
    1013.8
    2731.1
    OPA-7F Month 10
    795.5
    886.4
    1322.5
    1895.8
    OPA-7F Month 11
    5819.9
    5733.8
    8336.9
    18012.3
    OPA-9V Month 10
    281.5
    340.8
    433.7
    510.4
    OPA-9V Month 11
    2001.6
    2436.5
    3711.7
    6839.2
    OPA-14 Month 10
    275.8
    208.1
    355.6
    483.0
    OPA-14 Month 11
    2216.9
    2297.4
    2488.9
    3545.0
    OPA-18C Month 10
    5.1
    6.3
    6.7
    4.8
    OPA-18C Month 11
    374.6
    303.6
    511.0
    464.4
    OPA-19F Month 10
    18.0
    31.0
    30.7
    7.4
    OPA-19F Month 11
    650.2
    778.9
    1053.9
    767.1
    OPA-23F Month 10
    189.6
    281.4
    242.5
    367.4
    OPA-23F Month 11
    3621.0
    2563.6
    4465.4
    32508.0
    OPA-3 Month 10
    6.7
    8.3
    6.3
    12.0
    OPA-3 Month 11
    7.8
    7.8
    9.2
    333.9
    OPA-6A Month 10
    26.5
    23.3
    18.7
    129.7
    OPA-6A Month 11
    163.1
    190.0
    276.2
    4855.3
    OPA-19A Month 10
    211.8
    262.0
    315.6
    776.3
    OPA-19A Month 11
    2006.3
    2609.5
    2699.1
    7137.0
    12. Secondary Outcome
    Title Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Primary Phase of the Study
    Description Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    This analysis could not be performed as no validated assay was available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™ This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 0 0 0 0
    13. Secondary Outcome
    Title Concentrations of Antibodies Inhibiting Pneumococcal Pneumolysin Toxoid Haemolysis Activity - Booster Phase of the Study
    Description Analysis of the concentrations of antibodies inhibiting pneumococcal pneumolysin toxoid haemolysis activity (anti-Ply) was not performed as no assay was validated to perform this analysis. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    This analysis could not be performed as no validated assay was available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 0 0 0 0
    14. Secondary Outcome
    Title Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Primary Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 59 54 57 60
    ANTI-D At Month 3
    3.251
    3.185
    3.353
    2.933
    ANTI-T At Month 3
    2.579
    2.193
    2.252
    1.416
    15. Secondary Outcome
    Title Concentrations of Antibodies Against Diphtheria (Anti-D) and Tetanus (Anti-T) - Booster Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in International Units per milliliter (IU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.1 IU/mL. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 45 50 46 49
    ANTI-D At Month 10
    0.731
    0.587
    0.651
    0.614
    ANTI-D At Month 11
    9.872
    8.688
    9.742
    8.290
    ANTI-T At Month 10
    0.815
    0.727
    0.726
    0.371
    ANTI-T At Month 11
    8.725
    8.703
    9.929
    5.040
    16. Secondary Outcome
    Title Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Primary Phase of the Study
    Description Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 59 54 57 60
    ANTI-PT At Month 3
    69.0
    64.3
    70.0
    64.6
    ANTI-FHA At Month 3
    187.9
    178.1
    157.1
    188.6
    ANTI-PRN At Month 3
    95.1
    79.5
    91.4
    87.2
    17. Secondary Outcome
    Title Concentrations of Antibodies Against Pertussis Toxoid (Anti-PT), Filamentous Haemagglutinin (Anti-FHA), Pertactin (Anti-PRN) - Booster Phase of the Study
    Description Antibody concentrations will be measured by enzyme-linked immunosorbent assay (ELISA), expressed as geometric mean concentrations (GMCs) in Elisa Units per milliliter (EL.U/mL). The seropositivity cut-off of the assay was an antibody concentration higher than or equal to (≥) 5 EL.U/mL. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 45 50 46 49
    ANTI-PT At Month 10
    17.5
    12.7
    12.1
    12.2
    ANTI-PT At Month 11
    93.8
    90.6
    95.7
    85.2
    ANTI-FHA At Month 10
    63.0
    51.7
    48.5
    54.2
    ANTI-FHA At Month 11
    359.4
    380.1
    308.4
    376.7
    ANTI-PRN At Month 10
    21.8
    16.1
    14.3
    14.3
    ANTI-PRN At Month 11
    294.8
    228.5
    224.2
    197.3
    18. Secondary Outcome
    Title Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Primary Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Primary Phase of the study. Note that the percentage of subjects with concentration ≥10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 50 43 47 48
    Geometric Mean (95% Confidence Interval) [mIU/mL]
    676.7
    619.1
    719.8
    877.4
    19. Secondary Outcome
    Title Concentrations of Antibodies Against Hepatitis B (Anti-HBs) - Booster Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in milli-International Units per milliliter (mIU/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 10 mIU/mL. This outcome concerns results for the Booster Phase of the study. * A decrease in the specificity of the anti-HB Enzyme-Linked ImmunoSorbent Assay (ELISA) assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete reanalysis. The retest has been performed in using Food and Drug Administration (FDA)-approved ChemiLuminescence ImmunoAssay (CLIA) commercial assay Centaur™.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 60 65 62 64
    ANTI-HBs At Month 10
    299.2
    287.1
    166.6
    174.5
    ANTI-HBs At Month 11
    4110.9
    4234.8
    3142.4
    3116.4
    20. Secondary Outcome
    Title Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Primary Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 59 54 57 60
    Geometric Mean (95% Confidence Interval) [µg/mL]
    1.920
    1.975
    1.813
    0.963
    21. Secondary Outcome
    Title Concentrations of Antibodies Against Polyribosyl Ribitol Phosphate (Anti-PRP) - Booster Phase of the Study
    Description Antibody concentrations will be expressed as geometric mean concentrations (GMCs) in microgram per milliliter (µg/mL). The seroprotection cut-off of the assay was an antibody concentration higher than or equal to (≥) 0.15 µg/mL or 1 µg/mL. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 45 50 46 49
    ANTI-PRP At Month 10
    0.390
    0.446
    0.503
    0.272
    ANTI-PRP At Month 11
    16.961
    28.168
    24.549
    12.853
    22. Secondary Outcome
    Title Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Primary Phase of the Study
    Description Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Primary Phase of the study.
    Time Frame At Month 3, e. g. one month post-Dose 3 of pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 45 37 43 42
    ANTI-Polio 1 At Month 3
    175.7
    138.2
    190.3
    173.7
    ANTI-Polio 2 At Month 3
    134.3
    114.7
    177.6
    148.4
    ANTI-Polio 3 At Month 3
    445.7
    432.2
    552.7
    538.6
    23. Secondary Outcome
    Title Titers of Antibodies Against Poliovirus Types 1, 2 and 3 (Anti-1, Anti-2 and Anti-3) - Booster Phase of the Study
    Description Antibody titers will be measured by virus microneutralization test, expressed as geometric mean titers (GMTs). The cut-off of the assay for anti-1, anti-2 and anti-3 antibody was a titer higher than or equal to (≥) 8. This outcome concerns results for the Booster Phase of the study.
    Time Frame At Months 10 and 11, e.g. prior to and at one month post booster vaccination with pneumococcal vaccine (10PP, Synflorix™ or Prevnar 13™)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the According-To-Protocol cohort for immunogenicity adapted for each epoch which included all evaluable subjects for whom immunogenicity data were available for antibodies against at least one study antigen component after primary vaccination (primary phase) or before or after booster vaccination (booster phase).
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 42 46 36 43
    ANTI-Polio 1 At Month 10
    41.7
    58.3
    55.5
    55.4
    ANTI-Polio 1 At Month 11
    1116.0
    1222.0
    1149.6
    1233.2
    ANTI-Polio 2 At Month 10
    50.4
    55.9
    61.0
    66.8
    ANTI-Polio 2 At Month 11
    1998.1
    2332.2
    2048.3
    2284.8
    ANTI-Polio 3 At Month 10
    167.7
    104.9
    125.4
    93.1
    ANTI-Polio 3 At Month 11
    2995.8
    3626.3
    2696.8
    2820.0
    24. Secondary Outcome
    Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Primary Phase of the Study
    Description Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).
    Time Frame Within the 7-day (Days 0-6) periods post vaccination, after each dose (D) of the 3-dose primary vaccination course

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all subjects who received at least one of the 3 vaccine doses against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 146 142 144 142
    Any Pain, post D1
    52
    35.6%
    46
    32.4%
    53
    36.6%
    40
    28.2%
    Grade 3 Pain, post D1
    0
    0%
    2
    1.4%
    3
    2.1%
    0
    0%
    Any Redness, post D1
    59
    40.4%
    58
    40.8%
    52
    35.9%
    51
    35.9%
    Grade 3 Redness, post D1
    0
    0%
    0
    0%
    3
    2.1%
    2
    1.4%
    Any Swelling, post D1
    47
    32.2%
    46
    32.4%
    34
    23.4%
    37
    26.1%
    Grade 3 Swelling, post D1
    3
    2.1%
    5
    3.5%
    3
    2.1%
    6
    4.2%
    Any Pain, post D2
    52
    35.6%
    49
    34.5%
    42
    29%
    43
    30.3%
    Grade 3 Pain, post D2
    2
    1.4%
    0
    0%
    1
    0.7%
    2
    1.4%
    Any Redness, post D2
    67
    45.9%
    67
    47.2%
    63
    43.4%
    59
    41.5%
    Grade 3 Redness, post D2
    2
    1.4%
    2
    1.4%
    3
    2.1%
    0
    0%
    Any Swelling, post D2
    49
    33.6%
    56
    39.4%
    43
    29.7%
    38
    26.8%
    Grade 3 Swelling, post D2
    5
    3.4%
    4
    2.8%
    2
    1.4%
    3
    2.1%
    Any Pain, post D3
    41
    28.1%
    35
    24.6%
    37
    25.5%
    45
    31.7%
    Grade 3 Pain, post D3
    2
    1.4%
    3
    2.1%
    1
    0.7%
    1
    0.7%
    Any Redness, post D3
    65
    44.5%
    65
    45.8%
    58
    40%
    65
    45.8%
    Grade 3 Redness, post D3
    3
    2.1%
    2
    1.4%
    0
    0%
    3
    2.1%
    Any Swelling, post D3
    52
    35.6%
    52
    36.6%
    43
    29.7%
    43
    30.3%
    Grade 3 Swelling, post D3
    6
    4.1%
    3
    2.1%
    3
    2.1%
    5
    3.5%
    25. Secondary Outcome
    Title Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Booster Phase of the Study
    Description Assessed local symptoms were pain, redness and swelling at injection site. Any = Occurrence of the specified solicited local symptom, regardless of intensity. Grade 3 Pain = Crying when limb was moved/spontaneously painful. Grade 3 Redness/Swelling = Redness/swelling at injection site larger than (>) 30 millimeters (mm).
    Time Frame Within the 7-day (Days 0-6) period after booster vaccination

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 144 140 139 140
    Any Pain
    77
    52.7%
    73
    51.4%
    61
    42.1%
    68
    47.9%
    Grade 3 Pain
    7
    4.8%
    6
    4.2%
    3
    2.1%
    4
    2.8%
    Any Redness
    83
    56.8%
    81
    57%
    68
    46.9%
    66
    46.5%
    Grade 3 Redness
    11
    7.5%
    15
    10.6%
    12
    8.3%
    7
    4.9%
    Any Swelling
    70
    47.9%
    55
    38.7%
    49
    33.8%
    59
    41.5%
    Grade 3 Swelling
    8
    5.5%
    8
    5.6%
    7
    4.8%
    10
    7%
    26. Secondary Outcome
    Title Number of Subjects With Any, Grade 3 Solicited General Symptoms and Solicited General Symptoms With Relationship to Vaccination - Booster Phase of the Study
    Description Assessed solicited general symptoms were Drowsiness, Irritability, Loss of appetite (Loss Appet.) and Fever (rectal temperature higher than [≥] 38 degrees Celsius [°C]). Any = Occurrence of the specified solicited general symptom, regardless of intensity and relationship to vaccination. Related = Occurrence of the specified symptom assessed by the investigator as causally related to vaccination. Grade 3 Drowsiness = Drowsiness that prevented normal activity. Grade 3 Irritability = Crying that could not be comforted/prevented normal activity. Grade 3 Loss of appetite = Subject did not eat at all. Grade 3 Fever = Axillary temperature higher than (>) 40.0°C.
    Time Frame Within the 7-day (Days 0-6) period post vaccination after booster vaccination

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases, with analysis done solely on subjects with post-vaccination solicited symptoms results available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 144 140 139 140
    Any Drowsiness
    77
    52.7%
    64
    45.1%
    66
    45.5%
    73
    51.4%
    Grade 3 Drowsiness
    1
    0.7%
    5
    3.5%
    1
    0.7%
    1
    0.7%
    Related Drowsiness
    68
    46.6%
    61
    43%
    59
    40.7%
    69
    48.6%
    Any Irritability
    95
    65.1%
    84
    59.2%
    82
    56.6%
    90
    63.4%
    Grade 3 Irritability
    12
    8.2%
    8
    5.6%
    4
    2.8%
    8
    5.6%
    Related Irritability
    86
    58.9%
    82
    57.7%
    76
    52.4%
    83
    58.5%
    Any Loss Appet
    49
    33.6%
    38
    26.8%
    36
    24.8%
    57
    40.1%
    Grade 3 Loss Appet.
    3
    2.1%
    4
    2.8%
    2
    1.4%
    2
    1.4%
    Related Loss Appet.
    42
    28.8%
    38
    26.8%
    33
    22.8%
    49
    34.5%
    Any Fever
    50
    34.2%
    55
    38.7%
    51
    35.2%
    53
    37.3%
    Grade 3 Fever
    1
    0.7%
    0
    0%
    1
    0.7%
    3
    2.1%
    Related Fever
    44
    30.1%
    52
    36.6%
    45
    31%
    47
    33.1%
    27. Secondary Outcome
    Title Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Phase of the Study
    Description An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
    Time Frame Within the 31-day (Days 0-30) period post primary vaccination, across doses

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 146 142 145 142
    Count of Participants [Participants]
    55
    37.7%
    68
    47.9%
    64
    44.1%
    61
    43%
    28. Secondary Outcome
    Title Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Phase of the Study
    Description An unsolicited AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For the marketed products administered in the study, this also included failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse of the product. Any = Occurrence of an unsolicited AE, regardless of intensity or relationship to vaccination.
    Time Frame Within the 31-day (Days 0-30) period post booster vaccination

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort of Booster Phase, which included all subjects who received the booster dose of vaccine against pneumococcal diseases.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 144 140 140 140
    Count of Participants [Participants]
    40
    27.4%
    26
    18.3%
    27
    18.6%
    34
    23.9%
    29. Secondary Outcome
    Title Number of Subjects With Serious Adverse Events (SAEs)
    Description An SAE was defined as any medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity in a subject. AE(s) considered as SAE(s) also included invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm, blood dyscrasias or convulsions that did not result in hospitalization, as per the medical or scientific judgement of the physician. Any = Occurrence of an SAE, regardless of relationship to vaccination.
    Time Frame During the entire study period (Months 0-11)

    Outcome Measure Data

    Analysis Population Description
    The analysis was performed on the Total Vaccinated cohort for the Primary Phase, which included all vaccinated subjects with at least one of the 3 vaccine doses against pneumococcal diseases.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    Measure Participants 146 142 145 142
    Count of Participants [Participants]
    13
    8.9%
    9
    6.3%
    21
    14.5%
    17
    12%

    Adverse Events

    Time Frame Solicited symptoms: during the 7 days post-primary vaccination and post-booster vaccination. Unsolicited AEs during 31 days post-primary vaccination and post booster vaccination. SAEs: during the entire study period (Months 0-11).
    Adverse Event Reporting Description Solicited symptoms results are presented only for subjects for whom results were available.
    Arm/Group Title 10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Arm/Group Description This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™. This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
    All Cause Mortality
    10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/146 (0%) 0/142 (0%) 0/145 (0%) 0/142 (0%)
    Serious Adverse Events
    10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 13/146 (8.9%) 9/142 (6.3%) 21/145 (14.5%) 17/142 (12%)
    Congenital, familial and genetic disorders
    Phimosis 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 1/142 (0.7%)
    Gastrointestinal disorders
    Aphthous ulcer 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Diarrhoea 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Dyspepsia 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Rectal fissure 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Umbilical hernia 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    General disorders
    Localised oedema 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Infections and infestations
    Bronchitis 1/146 (0.7%) 1/142 (0.7%) 2/145 (1.4%) 3/142 (2.1%)
    Otitis media 3/146 (2.1%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Pneumonia 2/146 (1.4%) 1/142 (0.7%) 0/145 (0%) 1/142 (0.7%)
    Gastroenteritis 1/146 (0.7%) 1/142 (0.7%) 1/145 (0.7%) 0/142 (0%)
    Gastroenteritis rotavirus 1/146 (0.7%) 1/142 (0.7%) 0/145 (0%) 1/142 (0.7%)
    Laryngitis 0/146 (0%) 1/142 (0.7%) 0/145 (0%) 2/142 (1.4%)
    Bacterial infection 1/146 (0.7%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Pyelonephritis acute 0/146 (0%) 1/142 (0.7%) 1/145 (0.7%) 0/142 (0%)
    Respiratory tract infection 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 1/142 (0.7%)
    Urinary tract infection 1/146 (0.7%) 1/142 (0.7%) 0/145 (0%) 0/142 (0%)
    Campylobacter gastroenteritis 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Conjunctivitis 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Exanthema subitum 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Gastroenteritis Escherichia coli 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Gastroenteritis viral 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Hand-foot-and-mouth disease 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Nasopharyngitis 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Pyelonephritis 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Rhinitis 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Viral infection 0/146 (0%) 1/142 (0.7%) 0/145 (0%) 0/142 (0%)
    Injury, poisoning and procedural complications
    Concussion 0/146 (0%) 0/142 (0%) 3/145 (2.1%) 0/142 (0%)
    Thermal burn 1/146 (0.7%) 1/142 (0.7%) 0/145 (0%) 1/142 (0.7%)
    Accidental exposure to product by child 1/146 (0.7%) 0/142 (0%) 0/145 (0%) 0/142 (0%)
    Fall 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Head injury 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Skull fracture 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Metabolism and nutrition disorders
    Hypoglycaemia 0/146 (0%) 1/142 (0.7%) 1/145 (0.7%) 0/142 (0%)
    Decreased appetite 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Type 1 diabetes mellitus 0/146 (0%) 1/142 (0.7%) 0/145 (0%) 0/142 (0%)
    Nervous system disorders
    Febrile convulsion 0/146 (0%) 0/142 (0%) 0/145 (0%) 2/142 (1.4%)
    Burning sensation 0/146 (0%) 1/142 (0.7%) 0/145 (0%) 0/142 (0%)
    Epilepsy 0/146 (0%) 1/142 (0.7%) 0/145 (0%) 0/142 (0%)
    Hypotonia 1/146 (0.7%) 0/142 (0%) 0/145 (0%) 0/142 (0%)
    Hypotonic-hyporesponsive episode 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Psychiatric disorders
    Psychomotor retardation 1/146 (0.7%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Breath holding 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Renal and urinary disorders
    Nephrolithiasis 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Respiratory, thoracic and mediastinal disorders
    Apnoea 1/146 (0.7%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Skin and subcutaneous tissue disorders
    Skin discolouration 1/146 (0.7%) 0/142 (0%) 0/145 (0%) 0/142 (0%)
    Urticaria 0/146 (0%) 0/142 (0%) 0/145 (0%) 1/142 (0.7%)
    Vascular disorders
    Haematoma 0/146 (0%) 0/142 (0%) 1/145 (0.7%) 0/142 (0%)
    Other (Not Including Serious) Adverse Events
    10PP-LD/Infanrix Hexa Group 10PP-HD/Infanrix Hexa Group Synflorix/Infanrix Hexa Group Prevnar 13/Infanrix Hexa Group
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 141/146 (96.6%) 137/142 (96.5%) 139/145 (95.9%) 134/142 (94.4%)
    Eye disorders
    Conjunctivitis 5/146 (3.4%) 9/142 (6.3%) 5/145 (3.4%) 3/142 (2.1%)
    General disorders
    Pain 75/146 (51.4%) 73/142 (51.4%) 72/144 (50%) 64/142 (45.1%)
    Redness 96/146 (65.8%) 97/142 (68.3%) 88/144 (61.1%) 83/142 (58.5%)
    Swelling 82/146 (56.2%) 74/142 (52.1%) 60/144 (41.7%) 59/142 (41.5%)
    Drowsiness 107/146 (73.3%) 96/142 (67.6%) 98/144 (68.1%) 102/142 (71.8%)
    Irritability 118/146 (80.8%) 113/142 (79.6%) 110/144 (76.4%) 113/142 (79.6%)
    Loss of appetite 65/146 (44.5%) 59/142 (41.5%) 59/144 (41%) 57/142 (40.1%)
    Fever (rectal temperature >= 38°C) 76/146 (52.1%) 71/142 (50%) 74/144 (51.4%) 65/142 (45.8%)
    Pain 77/144 (53.5%) 73/140 (52.1%) 61/139 (43.9%) 68/140 (48.6%)
    Redness 83/144 (57.6%) 81/140 (57.9%) 68/139 (48.9%) 66/140 (47.1%)
    Swelling 70/144 (48.6%) 55/140 (39.3%) 49/139 (35.3%) 59/140 (42.1%)
    Drowsiness 77/144 (53.5%) 64/140 (45.7%) 66/139 (47.5%) 73/140 (52.1%)
    Irritability 95/144 (66%) 84/140 (60%) 82/139 (59%) 90/140 (64.3%)
    Loss of appetite 49/144 (34%) 38/140 (27.1%) 36/139 (25.9%) 57/140 (40.7%)
    Fever (rectal temperature >= 38°C) 50/144 (34.7%) 55/140 (39.3%) 51/139 (36.7%) 53/140 (37.9%)
    Infections and infestations
    Bronchitis 6/146 (4.1%) 12/142 (8.5%) 11/145 (7.6%) 13/142 (9.2%)
    Nasopharyngitis 10/146 (6.8%) 7/142 (4.9%) 12/145 (8.3%) 8/142 (5.6%)
    Nasopharyngitis 9/144 (6.3%) 4/140 (2.9%) 3/140 (2.1%) 6/140 (4.3%)
    Rhinitis 11/146 (7.5%) 11/142 (7.7%) 12/145 (8.3%) 14/142 (9.9%)
    Viral infection 0/146 (0%) 9/142 (6.3%) 5/145 (3.4%) 3/142 (2.1%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

    Results Point of Contact

    Name/Title GSK Response Center
    Organization GlaxoSmithKline
    Phone 866-435-7343
    Email
    Responsible Party:
    GlaxoSmithKline
    ClinicalTrials.gov Identifier:
    NCT01204658
    Other Study ID Numbers:
    • 113994
    • 2010-019730-27
    First Posted:
    Sep 17, 2010
    Last Update Posted:
    May 29, 2019
    Last Verified:
    May 1, 2019