Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01248884
• Collaborator: (none)
• Enrollment: 721
• Locations: 16
• Arms: 3
• Duration (Months): 12.9
• Patients Per Site: 45.1
• Patients Per Site Per Month: 3.5

Study Details

Study Description

Brief Summary

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

Condition or Disease	Intervention/Treatment	Phase
Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria	Biological: Infanrix hexa™; Biological: Prevenar 13®; Biological: GSK217744	Phase 2

Detailed Description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Study Design

• Study Type: Interventional
• Actual Enrollment: 721 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Prevention
• Official Title: Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination
• Study Start Date: Dec 9, 2010
• Actual Primary Completion Date: Jan 5, 2012
• Actual Study Completion Date: Jan 5, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GSK217744 Group 1 Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Biological: Prevenar 13®; 3 co-administered doses, intramuscular into right thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine ; Biological: GSK217744; 3 doses, intramuscular into left thigh
Experimental: GSK217744 Group 2 Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Biological: Prevenar 13®; 3 co-administered doses, intramuscular into right thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine ; Biological: GSK217744; 3 doses, intramuscular into left thigh
Active Comparator: Infanrix hexa Group Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Biological: Infanrix hexa™; 3 doses, intramuscular into left thigh; Other Names: DTPa-HBV-IPV/Hib ; Biological: Prevenar 13®; 3 co-administered doses, intramuscular into right thigh; Other Names: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. [At Month 0]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

2. Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. [At Month 3]

   A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).

3. Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies. [At Month 0]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

4. Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies. [At Month 3]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).

5. Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. [At Month 3]

   A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).

6. Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL) [At Month 3]

   A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.

7. Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL [At Month 3]

   A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).

Secondary Outcome Measures

1. Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. [At Months 0 and 3]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.

2. Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies. [At Months 0 and 3]

   A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

3. Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies. [At Month 3]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.

4. Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes. [At Month 3]

   A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

5. Concentrations for Anti-PNE Antibodies. [At Month 3]

   Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.

6. Number of Subjects With a Vaccine Response to PT and PRN. [At Month 3]

   Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.

7. Number of Subjects Reporting Any Solicited Local Symptoms. [During the 8-day (Days 0-7)]

   Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.

8. Number of Subjects Reporting Any Solicited General Symptoms. [During the 8-day (Days 0-7)]

   Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.

9. Number of Subjects Reporting Any Unsolicited Adverse Events (AEs). [Within the 31-day (Days 0-30) follow up period after vaccination.]

   An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.

10. Number of Subjects Reporting Any Serious Adverse Events (SAEs). [During the entire study period (Month 0 to Month 3)]

    SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Days to 90 Days
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.

• Born after a gestation period of 37 to 42 weeks inclusive.

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

• Written informed consent obtained from the parent(s)/ Legally Acceptable Representative(s) of the subject.

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

Exclusion Criteria:

• Child in care.

• Use of any investigational or non-registered product other than the study vaccines 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.

• Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.

• 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.

• Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.

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

• Family history of congenital or hereditary immunodeficiency.

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

• Major congenital defects or serious chronic illness.

• History of any neurological disorders or seizures.

• Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Santo Domingo, Distrito Nacional		Dominican Republic
2	GSK Investigational Site	Santo Domingo		Dominican Republic
3	GSK Investigational Site	Espoo		Finland	02100
4	GSK Investigational Site	Helsinki		Finland	00100
5	GSK Investigational Site	Helsinki		Finland	00930
6	GSK Investigational Site	Jarvenpaa		Finland	04400
7	GSK Investigational Site	Kokkola		Finland	67100
8	GSK Investigational Site	Kuopio		Finland	70210
9	GSK Investigational Site	Lahti		Finland	15140
10	GSK Investigational Site	Oulu		Finland	90220
11	GSK Investigational Site	Pori		Finland	28100
12	GSK Investigational Site	Seinajoki		Finland	60100
13	GSK Investigational Site	Tampere		Finland	33100
14	GSK Investigational Site	Turku		Finland	20520
15	GSK Investigational Site	Vantaa		Finland	01300
16	GSK Investigational Site	Vantaa		Finland	01600

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01248884
• Other Study ID Numbers: 113948
• First Posted: Nov 25, 2010
• Last Update Posted: Aug 20, 2018
• Last Verified: Jul 1, 2014

• Keywords provided by GlaxoSmithKline: combination vaccine; Primary vaccination
• Additional relevant MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Heptavalent Pneumococcal Conjugate Vaccine

Study Results

Participant Flow

Recruitment Details	A total of 721 subjects were enrolled in the study.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Period Title: Overall Study
STARTED	240	242	239
COMPLETED	238	239	238
NOT COMPLETED	2	3	1

Baseline Characteristics

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group	Total
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Total of all reporting groups
Overall Participants	240	242	239	721
Age (Weeks) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Weeks]	9.7 (1.36)	9.8 (1.29)	9.7 (1.21)	9.73 (1.29)
Sex: Female, Male (Count of Participants)
Female	119 49.6%	138 57%	99 41.4%	356 49.4%
Male	121 50.4%	104 43%	140 58.6%	365 50.6%
Race/Ethnicity, Customized (Count of Participants)
African heritage /African American	1 0.4%	0 0%	1 0.4%	2 0.3%
White - Arabic / north African heritage	3 1.3%	1 0.4%	6 2.5%	10 1.4%
White - Caucasian / European heritage	144 60%	148 61.2%	140 58.6%	432 59.9%
Unspecified	92 38.3%	93 38.4%	92 38.5%	277 38.4%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	200	210	211
Anti-D	154 64.2%	165 68.2%	160 66.9%
Anti-T	197 82.1%	206 85.1%	209 87.4%

2. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Description	A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	214	217	219
Anti-D	214 89.2%	217 89.7%	219 91.6%
Anti-T	214 89.2%	217 89.7%	219 91.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0
	Confidence Interval	(2-Sided) 97.5%; -2.25 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 1) in the percentage of seroprotected subject was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0
	Confidence Interval	(2-Sided) 97.5%; -2.25 to 2.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to diphteria antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0
	Confidence Interval	(2-Sided) 97.5%; -2.25 to 2.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to tetanus antigens was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK2177744 Group 2) in the percentage of seroprotected subject was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0
	Confidence Interval	(2-Sided) 97.5%; -2.25 to 2.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Primary Outcome

Title	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Time Frame	At Month 0

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	200	210	210
Anti-PT	3.3	3.4	3.1
Anti-PRN	5.1	4.9	4.9

4. Primary Outcome

Title	Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	215	217	219
Anti-PT	57.7	57.5	73.2
Anti-PRN	76.6	65.7	106.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.26
	Confidence Interval	(2-Sided) 97.5%; 1.11 to 1.44
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 1) was below or equal to 1.5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.33
	Confidence Interval	(2-Sided) 97.5%; 1.14 to 1.54
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigen (anti-PT) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.25
	Confidence Interval	(2-Sided) 97.5%; 1.1 to 1.43
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to pertussis antigen (anti-PRN) was demonstrated if the upper limit of the 97.5% confidence interval (CI) on the GMC ratio (Infanrix hexa Group divided by GSK2177744 Group 2) was below or equal to 1.5.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	GMC ratio
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 97.5%; 1.37 to 1.84
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Primary Outcome

Title	Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Description	A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	214	216	218
Count of Participants [Participants]	197 82.1%	190 78.5%	193 80.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-3.52
	Confidence Interval	(2-Sided) 97.5%; -10.19 to 3
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to PRP antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa Group minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.57
	Confidence Interval	(2-Sided) 97.5%; -6.53 to 7.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Primary Outcome

Title	Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Description	A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
Measure Participants	202	205	209
Anti-HBs ≥ 10 mIU/mL (ELISA)	197 82.1%	203 83.9%	205 85.8%
Anti-HBs ≥ 100 mIU/mL (ELISA)	184 76.7%	183 75.6%	196 82%
Anti-HBs ≥ 10 mIU/mL (CLIA)	197 82.1%	201 83.1%	203 84.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments	Immune response non-inferiority - anti-HBs (ELISA)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.56
	Confidence Interval	(2-Sided) 97.5%; -3.27 to 4.63
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments	Immune response non-inferiority - anti-HBs (ELISA)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.94
	Confidence Interval	(2-Sided) 97.5%; -4.57 to 2.36
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 1, Infanrix Hexa Group
	Comments	Immune response non-inferiority - anti-HBs (CLIA)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 1) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.4
	Confidence Interval	(2-Sided) 97.5%; -4.62 to 3.8
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	GSK217744 Group 2, Infanrix Hexa Group
	Comments	Immune response non-inferiority - anti-HBs (CLIA)
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority in terms of immune response to hepatitis B (HBs) antigens was demonstrated if the upper limit of the 97.5 confidence interval (CI) on the group difference (Infanrix hexa minus GSK217744 Group 2) in the percentage of seroprotected subjects was below or equal to 10%.
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-0.92
	Confidence Interval	(2-Sided) 97.5%; -5.07 to 3.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Primary Outcome

Title	Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL
Description	A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
Measure Participants	202	205	209
Geometric Mean (95% Confidence Interval) [mIU/mL]	639.5	602.6	799.0

8. Secondary Outcome

Title	Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Time Frame	At Months 0 and 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	214	217	219
Anti-D at Month 0	0.292	0.281	0.290
Anti-D at Month 3	1.499	1.704	1.839
Anti-T at Month 0	0.936	0.920	0.907
Anti-T at Month 3	1.761	1.726	1.947

9. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Description	A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame	At Months 0 and 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	215	217	219
Anti-PT at Month 0	33 13.8%	38 15.7%	31 13%
Anti-PT at Month 3	215 89.6%	217 89.7%	218 91.2%
Anti-PRN at Month 0	84 35%	89 36.8%	76 31.8%
Anti-PRN at Month 3	214 89.2%	215 88.8%	219 91.6%

10. Secondary Outcome

Title	Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	214	216	218
Geometric Mean (95% Confidence Interval) [µg/mL]	0.951	0.730	1.082

11. Secondary Outcome

Title	Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Description	A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	108	112	114
Anti- PNE 1	107 44.6%	112 46.3%	111 46.4%
Anti- PNE 3	106 44.2%	105 43.4%	107 44.8%
Anti- PNE 4	108 45%	112 46.3%	114 47.7%
Anti- PNE 5	107 44.6%	109 45%	109 45.6%
Anti- PNE 6A	108 45%	111 45.9%	112 46.9%
Anti- PNE 6B	97 40.4%	104 43%	102 42.7%
Anti- PNE 7F	107 44.6%	111 45.9%	114 47.7%
Anti- PNE 9V	107 44.6%	112 46.3%	113 47.3%
Anti- PNE 14	108 45%	112 46.3%	114 47.7%
Anti- PNE 18C	106 44.2%	112 46.3%	109 45.6%
Anti- PNE 19A	106 44.2%	112 46.3%	114 47.7%
Anti- PNE 19F	107 44.6%	111 45.9%	114 47.7%
Anti- PNE 23F	103 42.9%	104 43%	108 45.2%

12. Secondary Outcome

Title	Concentrations for Anti-PNE Antibodies.
Description	Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	108	112	114
Anti- PNE 1	1.61	1.48	1.58
Anti- PNE 3	0.91	0.91	0.94
Anti- PNE 4	1.80	1.62	1.69
Anti- PNE 5	0.79	0.77	0.82
Anti- PNE 6A	1.63	1.43	1.52
Anti- PNE 6B	0.66	0.64	0.69
Anti- PNE 7F	2.18	2.30	2.48
Anti- PNE 9V	1.12	1.11	1.16
Anti- PNE 14	7.47	7.80	8.03
Anti- PNE 18C	1.56	1.55	1.56
Anti- PNE 19A	2.70	2.75	2.68
Anti- PNE 19F	2.55	2.53	2.79
Anti- PNE 23F	0.89	0.83	0.91

13. Secondary Outcome

Title	Number of Subjects With a Vaccine Response to PT and PRN.
Description	Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.
Time Frame	At Month 3

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
Measure Participants	199	210	210
Anti- PT	195 81.3%	204 84.3%	207 86.6%
Anti- PRN	181 75.4%	194 80.2%	198 82.8%

14. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited Local Symptoms.
Description	Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 8-day (Days 0-7)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	240	240	238
Any pain	190 79.2%	183 75.6%	155 64.9%
Any redness	151 62.9%	140 57.9%	128 53.6%
Any swelling	124 51.7%	122 50.4%	115 48.1%

15. Secondary Outcome

Title	Number of Subjects Reporting Any Solicited General Symptoms.
Description	Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Time Frame	During the 8-day (Days 0-7)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	240	240	238
Any drowsiness	188 78.3%	185 76.4%	171 71.5%
Any irritability	197 82.1%	205 84.7%	191 79.9%
Any loss of appetite	135 56.3%	127 52.5%	112 46.9%
Any fever	180 75%	173 71.5%	140 58.6%

16. Secondary Outcome

Title	Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Description	An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Time Frame	Within the 31-day (Days 0-30) follow up period after vaccination.

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	240	242	239
Count of Participants [Participants]	153 63.8%	165 68.2%	159 66.5%

17. Secondary Outcome

Title	Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Description	SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Time Frame	During the entire study period (Month 0 to Month 3)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated cohort, which included all subjects for whom data were available.

Arm/Group Title	GSK217744 Group 1	GSK217744 Group 2	Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
Measure Participants	240	242	239
Count of Participants [Participants]	9 3.8%	5 2.1%	4 1.7%

Adverse Events

Time Frame	Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).
Arm/Group Title	GSK217744 Group 1		GSK217744 Group 2		Infanrix Hexa Group
Arm/Group Description	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.		Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.		Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
All Cause Mortality
	GSK217744 Group 1		GSK217744 Group 2		Infanrix Hexa Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	GSK217744 Group 1		GSK217744 Group 2		Infanrix Hexa Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	9/240 (3.8%)		5/242 (2.1%)		4/239 (1.7%)
Congenital, familial and genetic disorders
Scaphocephaly	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Gastrointestinal disorders
Gastrooesophageal reflux disease	0/240 (0%)		1/242 (0.4%)		0/239 (0%)
Infections and infestations
Bronchiolitis	4/240 (1.7%)		0/242 (0%)		3/239 (1.3%)
Pneumonia	1/240 (0.4%)		1/242 (0.4%)		1/239 (0.4%)
Amoebiasis	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Pyelonephritis	0/240 (0%)		1/242 (0.4%)		0/239 (0%)
Skin infection	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Tonsillitis	0/240 (0%)		1/242 (0.4%)		0/239 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of skin	0/240 (0%)		1/242 (0.4%)		0/239 (0%)
Respiratory, thoracic and mediastinal disorders
Asphyxia	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Bronchospasm	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Interstitial lung disease	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Respiratory tract congestion	1/240 (0.4%)		0/242 (0%)		0/239 (0%)
Other (Not Including Serious) Adverse Events
	GSK217744 Group 1		GSK217744 Group 2		Infanrix Hexa Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	240/240 (100%)		239/242 (98.8%)		235/239 (98.3%)
Eye disorders
Conjunctivitis	8/240 (3.3%)		7/242 (2.9%)		14/239 (5.9%)
Gastrointestinal disorders
Diarrhoea	13/240 (5.4%)		13/242 (5.4%)		21/239 (8.8%)
General disorders
Injection site induration	22/240 (9.2%)		14/242 (5.8%)		25/239 (10.5%)
Pain	190/240 (79.2%)		183/240 (76.3%)		155/238 (65.1%)
Redness	151/240 (62.9%)		140/240 (58.3%)		128/238 (53.8%)
Swelling	124/240 (51.7%)		122/240 (50.8%)		115/238 (48.3%)
Drowsiness	188/240 (78.3%)		185/240 (77.1%)		171/238 (71.8%)
Irritability	197/240 (82.1%)		205/240 (85.4%)		191/238 (80.3%)
Loss of appetite	135/240 (56.3%)		127/240 (52.9%)		112/238 (47.1%)
Fever	180/240 (75%)		173/242 (71.5%)		140/239 (58.6%)
Infections and infestations
Nasopharyngitis	53/240 (22.1%)		64/242 (26.4%)		51/239 (21.3%)
Upper respiratory tract infection	14/240 (5.8%)		21/242 (8.7%)		15/239 (6.3%)
Rhinitis	18/240 (7.5%)		14/242 (5.8%)		8/239 (3.3%)
Respiratory, thoracic and mediastinal disorders
Cough	7/240 (2.9%)		14/242 (5.8%)		8/239 (3.3%)

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.