Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00627458
• Collaborator: (none)
• Enrollment: 403
• Locations: 6
• Arms: 3
• Duration (Months): 6.5
• Patients Per Site: 67.2
• Patients Per Site Per Month: 10.3

Study Details

Study Description

Brief Summary

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).

Condition or Disease	Intervention/Treatment	Phase
Acellular Pertussis; Diphtheria; Poliomyelitis; Haemophilus Influenzae Type b; Tetanus; Hepatitis B	Biological: Infanrix Hexa	Phase 2

Detailed Description

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

Study Design

• Study Type: Interventional
• Actual Enrollment: 403 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
• Study Start Date: Feb 1, 2008
• Actual Primary Completion Date: Aug 18, 2008
• Actual Study Completion Date: Aug 18, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: INFANRIX HEXA PF GROUP Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Biological: Infanrix Hexa; Vaccine administered as a booster dose at 16-20 months of age; Other Names: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Experimental: INFANRIX HEXA PC GROUP Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Biological: Infanrix Hexa; Vaccine administered as a booster dose at 16-20 months of age; Other Names: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Active Comparator: CONTROL GROUP Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Biological: Infanrix Hexa; Vaccine administered as a booster dose at 16-20 months of age; Other Names: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine

Outcome Measures

Primary Outcome Measures

1. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids [Before the booster administration (At Month 0)]

   A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

2. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids [One month after the booster vaccination (At Month 1)]

   A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.

3. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) [Before the booster vaccination (At Month 0)]

   A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

4. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) [One month after the booster vaccination (At Month 1)]

   A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

5. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 [Before the booster vaccination (At Month 0)]

   A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

6. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 [One month after the booster vaccination (At Month 1)]

   A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.

7. Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) [Before the booster vaccination (At Month 0)]

   A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).

8. Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) [One month after the booster vaccination (At Month 1)]

   A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

9. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) [Before the booster vaccination (At Month 0)]

   A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

10. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) [One month after the booster vaccination (At Month 1)]

    A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

11. Number of Subjects With a Vaccine Response to PT, FHA and PR [One month after the booster vaccination (At Month 1)]

    Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).

12. Anti-D and Anti-T Antibody Concentrations [Before the booster vaccination (At Month 0)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

13. Anti-D and Anti-T Antibody Concentrations [One month after the booster vaccination (At Month 1)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

14. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [Before the booster vaccination (At Month 0)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

15. Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations [One month after the booster vaccination (At Month 1)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

16. Anti-HBs Antibody Concentrations [Before the booster vaccination (At Month 0)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

17. Anti-HBs Antibody Concentrations [One month after the booster vaccination (At Month 1)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

18. Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers [Before the booster vaccination (At Month 0)]

    Antibody titers were presented as geometric mean titers (GMTs).

19. Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers [One month after the booster vaccination (At Month 1)]

    Antibody titers were presented as geometric mean titers (GMTs).

20. Anti-PRP Antibody Concentrations [Before the booster vaccination (At Month 0)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).

21. Anti-PRP Antibody Concentrations [One month after the booster vaccination (At Month 1)]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

Secondary Outcome Measures

1. Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids [Before (Month 0) and one month after (Month 1) the booster vaccination]

   A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .

2. Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) [Before (Month 0) and one month after (Month 1) the booster vaccination]

   A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.

3. Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3 [Before (Month 0) and one month after (Month 1) the booster vaccination]

   A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.

4. Number of Seroprotected Subjects Against PT, FHA and PRN [Before (Month 0) and one month after (Month 1) the booster vaccination]

   A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .

5. Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) [Before (Month 0) and one month after (Month 1) the booster vaccination]

   A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.

6. Anti-D and Anti-T Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

7. Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

8. Anti-HBs Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

   Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.

9. Anti-poliovirus Type 1, 2 and 3 Antibody Titers [Before (Month 0) and one month after (Month 1) the booster vaccination]

   Antibody titers were presented as geometric mean titers (GMTs).

10. Anti-PRP Antibody Concentrations [Before (Month 0) and one month after (Month 1) the booster vaccination]

    Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

11. Number of Subjects With a Vaccine Response to PT, FHA and PR [One month after the booster dose (At Month 1)]

    Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).

12. Number of Subjects With Any Solicited Local Symptoms [During the 4-day (Days 0-3) follow-up period after the booster vaccination]

    Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

13. Number of Subjects With Any Solicited General Symptoms [During the 4-day (Days 0-3) follow-up period after the booster vaccination]

    Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.

14. Number of Subjects With Unsolicited Adverse Events (AEs) [During the 31-day (Day 0-30) follow-up period after the booster vaccination]

    An unsolicited AE covers 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

15. Number of Subjects With Serious Adverse Events (SAEs) [From Month 0 to Month 1, during the entire study period]

    Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

16. Number of Subjects Reporting Concomitant Medications [During the 4-day (Days 0-3) follow-up period after the booster vaccination]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Months to 20 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol

• Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.

• A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.

• Written informed consent obtained from the parent or guardian of the subject

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

Exclusion Criteria:

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

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.

• Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.

• Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.

• Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.

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

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.

• Acute disease at the time of enrolment.

• Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Jarvenpaa		Finland	04400
2	GSK Investigational Site	Oulu		Finland	90220
3	GSK Investigational Site	Pori		Finland	28100
4	GSK Investigational Site	Tampere		Finland	33100
5	GSK Investigational Site	Turku		Finland	20520
6	GSK Investigational Site	Vantaa		Finland	01300

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00627458
• Other Study ID Numbers: 111344
• First Posted: Mar 3, 2008
• Last Update Posted: Jun 6, 2018
• Last Verified: Apr 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Hexavalent vaccine; Booster
• Additional relevant MeSH terms: Hepatitis B; Diphtheria; Poliomyelitis; Vaccines

Study Results

Participant Flow

Pre-assignment Detail	During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Period Title: Overall Study
STARTED	127	137	139
COMPLETED	123	130	133
NOT COMPLETED	4	7	6

Baseline Characteristics

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group	Total
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Total of all reporting groups
Overall Participants	127	137	139	403
Age (Months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Months]	17.9 (1.12)	18 (1.03)	17.8 (1.11)	17.90 (1.09)
Sex: Female, Male (Count of Participants)
Female	56 44.1%	66 48.2%	59 42.4%	181 44.9%
Male	71 55.9%	71 51.8%	80 57.6%	222 55.1%
Race/Ethnicity, Customized (Count of Participants)
White-Caucasian/European heritage	125 98.4%	134 97.8%	135 97.1%	394 97.8%
White-Arabic/North African heritage	0 0%	1 0.7%	1 0.7%	2 0.5%
Not specified	2 1.6%	2 1.5%	3 2.2%	7 1.7%

Outcome Measures

1. Primary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description	A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Time Frame	Before the booster administration (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-D	22 17.3%	35 25.5%
Anti-T	93 73.2%	103 75.2%

2. Primary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description	A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113	119
Anti-D	112 88.2%	118 86.1%
Anti-T	113 89%	118 86.1%

3. Primary Outcome

Title	Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	117
Anti-HBs ≥ 10 mIU/mL	106 83.5%	112 81.8%
Anti HBs ≥ 100 mIU/mL	55 43.3%	54 39.4%

4. Primary Outcome

Title	Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	118
Anti-HBs ≥ 10 mIU/mL	110 86.6%	117 85.4%
Anti HBs ≥ 100 mIU/mL	105 82.7%	113 82.5%

5. Primary Outcome

Title	Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description	A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	117
Anti-polio 1	67 52.8%	76 55.5%
Anti-polio 2	48 37.8%	51 37.2%
Anti-polio 3	58 45.7%	77 56.2%

6. Primary Outcome

Title	Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description	A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-polio 1	110 86.6%	117 85.4%
Anti-polio 2	110 86.6%	117 85.4%
Anti-polio 3	111 87.4%	117 85.4%

7. Primary Outcome

Title	Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Description	A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-PT	80 63%	81 59.1%
Anti-FHA	106 83.5%	107 78.1%
Anti-PRN	81 63.8%	86 62.8%

8. Primary Outcome

Title	Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Description	A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113	119
Anti-PT	111 87.4%	118 86.1%
Anti-FHA	112 88.2%	118 86.1%
Anti-PRN	113 89%	117 85.4%

9. Primary Outcome

Title	Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description	A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	117
Anti-PRP ≥ 0.15μg/mL	71 55.9%	87 63.5%
Anti-PRP ≥ 1.0μg/mL	15 11.8%	23 16.8%

10. Primary Outcome

Title	Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description	A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	119
Anti-PRP ≥ 0.15 µg/mL	112 88.2%	119 86.9%
Anti-PRP ≥ 1.0 µg/mL	111 87.4%	117 85.4%

11. Primary Outcome

Title	Number of Subjects With a Vaccine Response to PT, FHA and PR
Description	Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	116
Anti-PT, S-	29 22.8%	30 21.9%
Anti-PT, S+	78 61.4%	81 59.1%
Anti-PT, Total	107 84.3%	111 81%
Anti-FHA, S-	4 3.1%	4 2.9%
Anti-FHA, S+	104 81.9%	106 77.4%
Anti-FHA, Total	108 85%	110 80.3%
Anti-PRN, S-	31 24.4%	30 21.9%
Anti-PRN, S+	81 63.8%	85 62%
Anti-PRN, Total	112 88.2%	115 83.9%

12. Primary Outcome

Title	Anti-D and Anti-T Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-D	0.064	0.069
Anti-T	0.216	0.248

13. Primary Outcome

Title	Anti-D and Anti-T Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113	119
Anti-D	2.237	2.242
Anti-T	9.799	9.136

14. Primary Outcome

Title	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-PT	7.8	7
Anti-FHA	21.7	22.1
Anti-PRN	8.6	8.7

15. Primary Outcome

Title	Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113	119
Anti-PT	150.9	117.1
Anti-FHA	609.6	533.7
Anti-PRN	308.5	311.7

16. Primary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	117
Geometric Mean (95% Confidence Interval) [mIU/mL]	84.3	86.2

17. Primary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	118
Geometric Mean (95% Confidence Interval) [mIU/mL]	3291.7	3528.1

18. Primary Outcome

Title	Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111	117
Anti-polio 1	12.9	15.2
Anti-polio 2	9.1	8.7
Anti-polio 3	9.5	16

19. Primary Outcome

Title	Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	117
Anti-polio 1	726.3	942.4
Anti-polio 2	712.8	812.9
Anti-polio 3	780	1145.8

20. Primary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Time Frame	Before the booster vaccination (At Month 0)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	119
Geometric Mean (95% Confidence Interval) [µg/mL]	0.249	0.314

21. Primary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame	One month after the booster vaccination (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	112	119
Geometric Mean (95% Confidence Interval) [µg/mL]	36.866	35.318

22. Secondary Outcome

Title	Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Description	A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-D, M0	40 31.5%
Anti-D, M1	119 93.7%
Anti-T, M0	95 74.8%
Anti-T, M1	119 93.7%

23. Secondary Outcome

Title	Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Description	A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	118
Anti-HBs ≥ 10 mIU/mL, M0	106 83.5%
Anti-HBs ≥ 10 mIU/mL, M1	118 92.9%
Anti HBs ≥ 100 mIU/mL, M0	67 52.8%
Anti HBs ≥ 100 mIU/mL, M1	114 89.8%

24. Secondary Outcome

Title	Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Description	A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113
Anti-polio 1, M0	84 66.1%
Anti-polio 1, M1	112 88.2%
Anti-polio 2, M0	56 44.1%
Anti-polio 2, M1	112 88.2%
Anti-polio 3, M0	82 64.6%
Anti-polio 3, M1	113 89%

25. Secondary Outcome

Title	Number of Seroprotected Subjects Against PT, FHA and PRN
Description	A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-PT, M0	93 73.2%
Anti-PT, M1	119 93.7%
Anti-FHA, M0	109 85.8%
Anti-FHA, M1	119 93.7%
Anti-PRN, M0	99 78%
Anti-PRN, M1	119 93.7%

26. Secondary Outcome

Title	Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Description	A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-PRP ≥ 0.15 μg/mL, M0	92 72.4%
Anti-PRP ≥ 0.15 μg/mL, M1	119 93.7%
Anti-PRP ≥ 1.0 μg/mL, M0	32 25.2%
Anti-PRP ≥ 1.0 μg/mL, M1	118 92.9%

27. Secondary Outcome

Title	Anti-D and Anti-T Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-D, M0	0.084
Anti-D, M1	3.952
Anti-T, M0	0.261
Anti-T, M1	10.833

28. Secondary Outcome

Title	Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-PT, M0	8.9
Anti-PT, M1	153.7
Anti-FHA, M0	33.7
Anti-FHA, M1	791.9
Anti-PRN, M0	15.3
Anti-PRN, M1	564.1

29. Secondary Outcome

Title	Anti-HBs Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	118
Anti-HBs, M0	139.8
Anti-HBs, M1	6132.7

30. Secondary Outcome

Title	Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Description	Antibody titers were presented as geometric mean titers (GMTs).
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	113
Anti-polio 1, M0	21.6
Anti-polio 1, M1	1288.8
Anti-polio 2, M0	11.8
Anti-polio 2, M1	1231
Anti-polio 3, M0	21.3
Anti-polio 3, M1	1794.8

31. Secondary Outcome

Title	Anti-PRP Antibody Concentrations
Description	Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame	Before (Month 0) and one month after (Month 1) the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	119
Anti-PRP, M0	0.487
Anti-PRP, M1	77.087

32. Secondary Outcome

Title	Number of Subjects With a Vaccine Response to PT, FHA and PR
Description	Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).
Time Frame	One month after the booster dose (At Month 1)

Outcome Measure Data

Analysis Population Description

The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.

Arm/Group Title	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	111
Anti-PT, S-	17 13.4%
Anti-PT, S+	93 73.2%
Anti-PT, Total	110 86.6%
Anti-FHA, S-	0 0%
Anti-FHA, S+	105 82.7%
Anti-FHA, Total	105 82.7%
Anti-PRN, S-	12 9.4%
Anti-PRN, S+	98 77.2%
Anti-PRN, Total	110 86.6%

33. Secondary Outcome

Title	Number of Subjects With Any Solicited Local Symptoms
Description	Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	126	136	138
Any Pain	74 58.3%	76 55.5%	82 59%
Any Redness	66 52%	79 57.7%	94 67.6%
Any Swelling	44 34.6%	53 38.7%	60 43.2%

34. Secondary Outcome

Title	Number of Subjects With Any Solicited General Symptoms
Description	Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time Frame	During the 4-day (Days 0-3) follow-up period after the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	126	136	138
Any Drowsiness	50 39.4%	48 35%	58 41.7%
Any Fever (Rectal)	22 17.3%	34 24.8%	31 22.3%
Any Irritability	68 53.5%	86 62.8%	78 56.1%
Any Loss of Appetite	37 29.1%	46 33.6%	45 32.4%

35. Secondary Outcome

Title	Number of Subjects With Unsolicited Adverse Events (AEs)
Description	An unsolicited AE covers 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 and 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame	During the 31-day (Day 0-30) follow-up period after the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	127	137	139
Count of Participants [Participants]	51 40.2%	54 39.4%	61 43.9%

36. Secondary Outcome

Title	Number of Subjects With Serious Adverse Events (SAEs)
Description	Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame	From Month 0 to Month 1, during the entire study period

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	127	137	139
Count of Participants [Participants]	1 0.8%	2 1.5%	1 0.7%

37. Secondary Outcome

Title	Number of Subjects Reporting Concomitant Medications
Time Frame	During the 4-day (Days 0-3) follow-up period after the booster vaccination

Outcome Measure Data

Analysis Population Description

The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.

Arm/Group Title	Infanrix Hexa PF Group	Infanrix Hexa PC Group	Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
Measure Participants	127	137	139
Any concomitant medication	105 82.7%	111 81%	116 83.5%
Any antipyretic	34 26.8%	35 25.5%	33 23.7%

Adverse Events

Time Frame	Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
Arm/Group Title	Infanrix Hexa PF Group		Infanrix Hexa PC Group		Control Group
Arm/Group Description	Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.		Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.		Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
All Cause Mortality
	Infanrix Hexa PF Group		Infanrix Hexa PC Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/127 (0%)		0/137 (0%)		0/139 (0%)
Serious Adverse Events
	Infanrix Hexa PF Group		Infanrix Hexa PC Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/127 (0.8%)		2/137 (1.5%)		1/139 (0.7%)
Infections and infestations
Gastroenteritis rotavirus	1/127 (0.8%)		1/137 (0.7%)		0/139 (0%)
Gastroenteritis	0/127 (0%)		1/137 (0.7%)		0/139 (0%)
Pneumonia adenoviral	0/127 (0%)		0/137 (0%)		1/139 (0.7%)
Other (Not Including Serious) Adverse Events
	Infanrix Hexa PF Group		Infanrix Hexa PC Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	116/127 (91.3%)		126/137 (92%)		129/139 (92.8%)
Gastrointestinal disorders
Diarrhoea	7/127 (5.5%)		4/137 (2.9%)		5/139 (3.6%)
General disorders
Pain	74/126 (58.7%)		76/136 (55.9%)		82/138 (59.4%)
Redness	66/126 (52.4%)		79/136 (58.1%)		94/138 (68.1%)
Swelling	44/126 (34.9%)		53/136 (39%)		60/138 (43.5%)
Drowsiness	50/126 (39.7%)		48/136 (35.3%)		58/138 (42%)
Fever/(Rectal)	22/126 (17.5%)		34/136 (25%)		31/138 (22.5%)
Irritability	68/126 (54%)		86/136 (63.2%)		78/138 (56.5%)
Loss of appetite	37/126 (29.4%)		46/136 (33.8%)		45/138 (32.6%)
Pyrexia	6/127 (4.7%)		5/137 (3.6%)		8/139 (5.8%)
Injection site induration	5/127 (3.9%)		2/137 (1.5%)		10/139 (7.2%)
Infections and infestations
Otitis media	4/127 (3.1%)		7/137 (5.1%)		14/139 (10.1%)
Upper respiratory tract infection	9/127 (7.1%)		8/137 (5.8%)		6/139 (4.3%)
Rhinitis	3/127 (2.4%)		8/137 (5.8%)		9/139 (6.5%)
Respiratory, thoracic and mediastinal disorders
Cough	2/127 (1.6%)		9/137 (6.6%)		0/139 (0%)

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.