Trial Outcomes & Findings for Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants (NCT NCT00586612)

Results Overview

Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

313 participants

Primary outcome timeframe

One month after the third vaccination

Results posted on

2018-08-27

Participant Flow

Participant milestones

Participant milestones
Measure	Preterm Group Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Primary Phase STARTED	163	150
Primary Phase COMPLETED	162	147
Primary Phase NOT COMPLETED	1	3
Booster Phase STARTED	154	144
Booster Phase COMPLETED	151	143
Booster Phase NOT COMPLETED	3	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Preterm Group Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Primary Phase Protocol Violation	1	0
Primary Phase Lost to Follow-up	0	1
Primary Phase Withdrawal by Subject	0	2
Booster Phase Lost to Follow-up	3	1

Baseline Characteristics

Primary & Booster Study to Evaluate the Immunogenicity and Safety of Menitorix Vaccine in Preterm Infants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Preterm Group n=163 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Total n=313 Participants Total of all reporting groups
Age, Continuous	8.9 weeks STANDARD_DEVIATION 1.15 • n=5 Participants	8.8 weeks STANDARD_DEVIATION 0.79 • n=7 Participants	8.9 weeks STANDARD_DEVIATION 0.99 • n=5 Participants
Sex: Female, Male Female	77 Participants n=5 Participants	65 Participants n=7 Participants	142 Participants n=5 Participants
Sex: Female, Male Male	86 Participants n=5 Participants	85 Participants n=7 Participants	171 Participants n=5 Participants

PRIMARY outcome

Timeframe: One month after the third vaccination

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for immunogenicity, on subjects with available data.

Anti-PRP antibody concentration greater than or equal to 0.15 µg/mL is indicative of protection.

Outcome measures

Outcome measures
Measure	Preterm Group n=140 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=142 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Micrograms Per Milliliter (µg/mL)	139 subjects	141 subjects

PRIMARY outcome

Timeframe: One month after the third vaccination

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

rSBA-MenC titer greater than or equal to 1:8 is indicative of protection.

Outcome measures

Outcome measures
Measure	Preterm Group n=143 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=140 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to 1:8	142 subjects	140 subjects

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PRP antibody cut-off values assessed include 0.15 micrograms per milliliter (µg/mL) and 1 µg/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=140 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=138 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 0.15 µg/mL	38 subjects	43 subjects
Number of Subjects With Anti-Polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 1.0 µg/mL	5 subjects	9 subjects

SECONDARY outcome

Timeframe: One month after the third vaccination

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PRP antibody cut-off value assessed include 1 microgram per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=140 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=142 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subject With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1 Microgram Per Milliliter	133 subjects	134 subjects

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.

Outcome measures

Outcome measures
Measure	Preterm Group n=141 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=137 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:8	16 subjects	23 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:32	5 subjects	11 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:128	0 subjects	3 subjects

SECONDARY outcome

Timeframe: One month after the third vaccination

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

rSBA-MenC titer cut-off values assessed include 1:32 and 1:128.

Outcome measures

Outcome measures
Measure	Preterm Group n=143 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=140 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:32	142 subjects	139 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:128	135 subjects	136 subjects

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=142 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=137 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 0.3 µg/mL	23 subjects	36 subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 2.0 µg/mL	3 subjects	8 subjects

SECONDARY outcome

Timeframe: One month after the third dose

Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2 µg/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=140 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=141 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 0.3 µg/mL	140 subjects	141 subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 2.0 µg/mL	127 subjects	136 subjects

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=112 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=118 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 10 mIU/mL	89 subjects	78 subjects
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 100 mIU/mL	3 subjects	8 subjects

SECONDARY outcome

Timeframe: One month after the third dose

Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=129 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=129 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 10 mIU/mL	128 subjects	129 subjects
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to (≥) the Cut-off Values ≥ 100 mIU/mL	109 subjects	117 subjects

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=142 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=138 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Anti-PRP (n=140, 138)	0.116 micrograms per milliliter (µg/mL) Interval 0.101 to 0.133	0.140 micrograms per milliliter (µg/mL) Interval 0.117 to 0.167
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Anti-PSC (n=142, 137)	0.19 micrograms per milliliter (µg/mL) Interval 0.17 to 0.22	0.25 micrograms per milliliter (µg/mL) Interval 0.21 to 0.3

SECONDARY outcome

Timeframe: One month after the third dose

Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) expressed micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=140 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=142 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Anti-PRP (n= 140, 142)	10.437 micrograms per milliliter (µg/mL) Interval 8.398 to 12.97	10.473 micrograms per milliliter (µg/mL) Interval 8.547 to 12.833
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration Anti-PSC (n= 140, 141)	6.34 micrograms per milliliter (µg/mL) Interval 5.57 to 7.22	7.46 micrograms per milliliter (µg/mL) Interval 6.67 to 8.34

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=112 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=118 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration	24.79 mIU/mL Interval 19.82 to 31.0	16.67 mIU/mL Interval 13.52 to 20.56

SECONDARY outcome

Timeframe: One month after the third dose

Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

Anti-HBs concentrations are given as geometric mean concentrations (GMCs) expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=129 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=129 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration	372.30 mIU/mL Interval 299.98 to 462.04	586.58 mIU/mL Interval 473.8 to 726.21

SECONDARY outcome

Timeframe: Before vaccination (at Day 0)

Population: Analysis was performed on the Primary According-to-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

rSBA-MenC titers are given as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=141 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=137 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer	4.9 Titer Interval 4.5 to 5.5	5.9 Titer Interval 4.9 to 6.9

SECONDARY outcome

Timeframe: One month after the third dose

Population: Analysis was performed on the Primary According-To-Protocol (ATP) cohort for analysis of immunogenicity, on subjects with available data.

rSBA-MenC titers are given as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=143 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=140 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer	1055.9 Titer Interval 859.1 to 1297.7	1346.2 Titer Interval 1130.4 to 1603.1

SECONDARY outcome

Timeframe: During the 4-day follow-up period after any primary vaccination dose

Population: Analysis was performed on the Primary Total Vaccinated Cohort.

Solicited local symptoms assessed include pain, redness and swelling and are presented across doses.

Outcome measures

Outcome measures
Measure	Preterm Group n=163 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Solicited Local Symptoms Pain	106 subjects	100 subjects
Number of Subjects Reporting Solicited Local Symptoms Redness	94 subjects	123 subjects
Number of Subjects Reporting Solicited Local Symptoms Swelling	91 subjects	113 subjects

SECONDARY outcome

Timeframe: During the 4-day follow-up period after any primary vaccination dose

Population: Analysis was performed on the Primary Total Vaccinated Cohort.

Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite and are presented across doses.

Outcome measures

Outcome measures
Measure	Preterm Group n=163 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Solicited General Symptoms Drowsiness	111 subjects	102 subjects
Number of Subjects Reporting Solicited General Symptoms Fever	89 subjects	85 subjects
Number of Subjects Reporting Solicited General Symptoms Irritability/fussiness	128 subjects	105 subjects
Number of Subjects Reporting Solicited General Symptoms Loss of appetite	99 subjects	100 subjects

SECONDARY outcome

Timeframe: Within 31 days after each primary vaccination

Population: Analysis was performed on the Primary Total Vaccinated Cohort.

Unsolicited AE covers any AE 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.

Outcome measures

Outcome measures
Measure	Preterm Group n=163 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	56 subjects	72 subjects

SECONDARY outcome

Timeframe: Throughout the entire primary vaccination phase

Population: Analysis was performed on the Primary Total Vaccinated Cohort.

SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

Outcome measures

Outcome measures
Measure	Preterm Group n=163 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Serious Adverse Events (SAEs)	11 subjects	8 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-PRP antibody cut-off value assessed was 0.15 migrogram per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=133 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=134 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) Pre-booster (n= 133; 130)	116 subjects	117 subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 0.15 Migrogram Per Milliliter (µg/mL) Post-booster (n= 132; 134)	132 subjects	134 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-PRP antibody cut-off value assessed was 1.0 migrogram per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=133 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=134 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) Pre-booster (n= 133; 130)	53 subjects	53 subjects
Number of Subjects With Anti-polyribosylribitol Phosphate (Anti-PRP) Antibody Concentration Greater Than or Equal to 1.0 Migrogram Per Milliliter (µg/mL) Post-booster (n= 132; 134)	132 subjects	134 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

rSBA-MenC titer cut-off values assessed include 1:8, 1:32 and 1:128.

Outcome measures

Outcome measures
Measure	Preterm Group n=134 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=137 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:128 pre-booster (n= 134; 134)	69 subjects	85 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:128 post-booster (n= 133; 137)	131 subjects	136 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:8 pre-booster (n= 134; 134)	102 subjects	117 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:8 post-booster (n= 133; 137)	132 subjects	136 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:32 pre-booster (n= 134; 134)	95 subjects	115 subjects
Number of Subjects With Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Greater Than or Equal to the Cut-off Values ≥ 1:32 post-booster (n= 133; 137)	132 subjects	136 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-PSC antibody cut-off values assessed include 0.3 micrograms per milliliter (µg/mL) and 2.0 µg/mL.

Outcome measures

Outcome measures
Measure	Preterm Group n=130 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=129 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 0.3 µg/mL pre-booster (n= 130; 127)	74 subjects	92 subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 0.3 µg/mL post-booster (n= 117; 129)	116 subjects	129 subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 2.0 µg/mL pre-booster (n= 130; 127)	11 subjects	11 subjects
Number of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 2.0 µg/mL post-booster (n= 117; 129)	105 subjects	124 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) the booster vaccination

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-HBs antibody cut-off values assessed include 10 milli-international units per milliliter (mIU/mL) and 100 mIU/mL. Note: the protocol planned an analysis on HBs after the booster dose, but this analysis was not performed as the vaccines administered as booster doses did not contain HBs component.

Outcome measures

Outcome measures
Measure	Preterm Group n=125 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=116 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 10 mIU/mL pre-booster	121 subjects	113 subjects
Number of Subjects With Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentration Greater Than or Equal to the Cut-off Values ≥ 100 mIU/mL pre-booster	61 subjects	71 subjects

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-PRP and anti-PSC concentrations are given as geometric mean concentrations (GMCs) in micrograms per milliliter (µg/mL).

Outcome measures

Outcome measures
Measure	Preterm Group n=133 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=134 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration anti-PRP pre-booster (n= 133; 130)	0.706 micrograms per milliliter (µg/mL) Interval 0.565 to 0.881	0.777 micrograms per milliliter (µg/mL) Interval 0.622 to 0.972
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration anti-PRP post-booster (n= 132; 134)	50.343 micrograms per milliliter (µg/mL) Interval 41.627 to 60.884	54.625 micrograms per milliliter (µg/mL) Interval 45.325 to 65.834
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration anti-PSC pre-booster (n= 130; 127)	0.42 micrograms per milliliter (µg/mL) Interval 0.35 to 0.51	0.56 micrograms per milliliter (µg/mL) Interval 0.47 to 0.67
Anti-polyribosylribitol Phosphate (Anti-PRP) and Anti-polysaccharide C (Anti-PSC) Concentration anti-PSC post-booster (n= 117; 129)	10.06 micrograms per milliliter (µg/mL) Interval 8.14 to 12.45	11.31 micrograms per milliliter (µg/mL) Interval 9.6 to 13.31

SECONDARY outcome

Timeframe: Prior to (Month 14) the booster vaccination

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

Anti-HBs concentrations are given as geometric mean concentrations (GMCs) in milli-international units per milliliter (mIU/mL). Note: Planned analysis in the protocol of HBs after the booster dose was not performed as booster vaccines did not contain HBs component.

Outcome measures

Outcome measures
Measure	Preterm Group n=125 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=116 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Anti-hepatitis B Surface Antigen (Anti-HBs) Concentration	95.9 mIU/mL Interval 75.6 to 121.5	145.6 mIU/mL Interval 112.1 to 189.1

SECONDARY outcome

Timeframe: Prior to (Month 14) and one month after the booster vaccination (Month 15)

Population: Analysis was performed on the Booster ATP cohort for immunogenicity, which included subjects having received 3 vaccine doses during the primary vaccination course and the booster vaccine dose and for whom assay results were available for antibodies against at least one study vaccine antigen component after booster dose administration.

rSBA-MenC titers are given as geometric mean titers (GMTs).

Outcome measures

Outcome measures
Measure	Preterm Group n=134 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=137 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Pre-booster (n= 134; 134)	79.3 titer Interval 56.3 to 111.8	147.8 titer Interval 110.9 to 197.1
Meningococcal Serogroup C Serum Bactericidal Assay Using Rabbit Complement (rSBA-MenC) Titer Post-booster (n= 133; 137)	4883.1 titer Interval 3783.1 to 6302.9	5288.8 titer Interval 4244.9 to 6589.4

SECONDARY outcome

Timeframe: During the 4-day follow-up period following booster vaccination

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.

Solicited local symptoms assessed include pain, redness and swelling. Solicited general symptoms assessed include drowsiness, fever, irritability/fussiness and loss of appetite.

Outcome measures

Outcome measures
Measure	Preterm Group n=154 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=144 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Solicited Symptoms (Local and General) Pain	82 subjects	98 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Redness	77 subjects	109 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Swelling	67 subjects	94 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Drowsiness	33 subjects	46 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Fever	43 subjects	53 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Irritability	70 subjects	69 subjects
Number of Subjects Reporting Solicited Symptoms (Local and General) Loss of appetite	34 subjects	50 subjects

SECONDARY outcome

Timeframe: Within 31 days after the booster vaccination (month 15)

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.

Unsolicited AE covers any AE 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.

Outcome measures

Outcome measures
Measure	Preterm Group n=154 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=144 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Unsolicited Adverse Events (AEs)	34 subjects	42 subjects

SECONDARY outcome

Timeframe: 31 days after last primary vaccination until administration of booster dose (Month 14) and from the administration of the booster dose until the end of the study (Month 15)

Population: Analysis was performed on the Booster Total Vaccinated cohort which included all vaccinated subjects for whom data for the booster phase were available.

SAEs assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Period 1 is defined as 31 days after last primary vaccination until administration of booster dose (Month 14). Period 2 is defined as the administration of the booster dose until the end of the study (Month 15).

Outcome measures

Outcome measures
Measure	Preterm Group n=154 Participants Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=144 Participants Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
Number of Subjects Reporting Serious Adverse Events (SAEs) Period 1	10 subjects	2 subjects
Number of Subjects Reporting Serious Adverse Events (SAEs) Period 2	1 subjects	0 subjects

Adverse Events

Preterm Group

Serious events: 22 serious events

Other events: 153 other events

Deaths: 0 deaths

Full-term Group

Serious events: 10 serious events

Other events: 144 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Preterm Group n=163 participants at risk Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.	Full-term Group n=150 participants at risk Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
General disorders Injection site nodule	1.8% 3/163 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	16.0% 24/150 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
Infections and infestations Upper respiratory tract infection	4.3% 7/163 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	7.3% 11/150 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
Gastrointestinal disorders Vomiting	5.5% 9/163 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	4.0% 6/150 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Injection site haematoma	0.61% 1/163 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	6.0% 9/150 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Pain	53.2% 82/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	68.1% 98/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Redness	50.0% 77/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	75.7% 109/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Swelling	43.5% 67/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	65.3% 94/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Drowsiness	21.4% 33/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	31.9% 46/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Fever	27.9% 43/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	36.8% 53/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Irritability/fussiness	45.5% 70/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	47.9% 69/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.
General disorders Loss of appetite	22.1% 34/154 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.	34.7% 50/144 • For SAEs: the whole study period (Day 0 - Month 15); For frequent adverse events: solicited adverse events a 4-day period after vaccination, unsolicited adverse events a 31-day period after vaccination. Solicited adverse events after primary and booster vaccination are put as separate adverse events. In the description field of these adverse events it is specified to which vaccination phase they belong.

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER