Trial Outcomes & Findings for Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine (NCT NCT01086423)

NCT ID: NCT01086423

Last Updated: 2018-06-06

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 985 participants
• Primary outcome timeframe: One month after the third vaccine dose (Month 3 or Month 4)
• Results posted on: 2018-06-06

Participant Flow

Out of the 985 subjects originally enrolled in the study, 984 subjects were vaccinated with at least one dose of the study vaccine.

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

Participant milestones

Measure	Infanrix-IPV+Hib 1 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Overall Study STARTED	330	324	330
Overall Study COMPLETED	320	321	321
Overall Study NOT COMPLETED	10	3	9

Reasons for withdrawal

Measure	Infanrix-IPV+Hib 1 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Overall Study Protocol Violation	0	0	1
Overall Study Migrated/moved from study area	2	0	4
Overall Study Adverse event, fatal	1	1	0
Overall Study Adverse event, non-fatal	2	1	0
Overall Study Withdrawal by Subject	5	1	3
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Immunogenicity and Safety Study of GSK Biologicals' Infanrix-IPV+Hib™ Vaccine

Baseline characteristics by cohort

Measure	Infanrix-IPV+Hib 1 Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.	Total n=984 Participants Total of all reporting groups
Age, Continuous	9.9 Weeks STANDARD_DEVIATION 1.12 • n=5 Participants	14.3 Weeks STANDARD_DEVIATION 1.14 • n=7 Participants	9.9 Weeks STANDARD_DEVIATION 1.17 • n=5 Participants	11.35 Weeks STANDARD_DEVIATION 2.36 • n=4 Participants
Sex: Female, Male Female	155 Participants n=5 Participants	147 Participants n=7 Participants	141 Participants n=5 Participants	443 Participants n=4 Participants
Sex: Female, Male Male	175 Participants n=5 Participants	177 Participants n=7 Participants	189 Participants n=5 Participants	541 Participants n=4 Participants
Race/Ethnicity, Customized Asian-Chinese heritage	330 Participants n=5 Participants	324 Participants n=7 Participants	330 Participants n=5 Participants	984 Participants n=4 Participants

PRIMARY outcome

Timeframe: One month after the third vaccine dose (Month 3 or Month 4)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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).

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=156 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-D	146 Participants	156 Participants	147 Participants
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Anti-T	147 Participants	156 Participants	147 Participants

PRIMARY outcome

Timeframe: One month after the third vaccine dose (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=150 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen	142 Participants	155 Participants	133 Participants

PRIMARY outcome

Timeframe: One month after the third vaccine dose (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=150 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens Anti-polio 1	147 Participants	157 Participants	150 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens Anti-polio 2	147 Participants	157 Participants	150 Participants
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens Anti-polio 3	147 Participants	157 Participants	150 Participants

PRIMARY outcome

Timeframe: One month after the third vaccine dose (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

Vaccine response was defined as:

For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination.

For PRN response: for initially seronegative subjects [antibody concentration lower than (<) 5 EL.U/mL], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=156 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=148 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PT	147 Participants	155 Participants	147 Participants
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-FHA	147 Participants	155 Participants	144 Participants
Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens Anti-PRN	145 Participants	156 Participants	145 Participants

SECONDARY outcome

Timeframe: Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=151 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Anti-D and Anti-T Antibody Concentrations Anti-D, M0	0.052 IU/mL Interval 0.05 to 0.053	0.051 IU/mL Interval 0.05 to 0.052	0.051 IU/mL Interval 0.049 to 0.052
Anti-D and Anti-T Antibody Concentrations Anti-D, M3/M4	0.719 IU/mL Interval 0.661 to 0.782	0.753 IU/mL Interval 0.699 to 0.812	0.613 IU/mL Interval 0.565 to 0.666
Anti-D and Anti-T Antibody Concentrations Anti-T, M0	0.051 IU/mL Interval 0.05 to 0.052	0.052 IU/mL Interval 0.05 to 0.054	0.05 IU/mL Interval 0.05 to 0.05
Anti-D and Anti-T Antibody Concentrations Anti-T, M3/M4	4.118 IU/mL Interval 3.779 to 4.488	4.124 IU/mL Interval 3.796 to 4.479	3.618 IU/mL Interval 3.339 to 3.921

SECONDARY outcome

Timeframe: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=151 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Anti-PRP Antibody Concentrations Anti-PRP, M0	0.127 µg/mL Interval 0.104 to 0.154	0.135 µg/mL Interval 0.112 to 0.163	0.15 µg/mL Interval 0.122 to 0.185
Anti-PRP Antibody Concentrations Anti-PRP, M3/M4	5.601 µg/mL Interval 4.676 to 6.709	9.396 µg/mL Interval 8.032 to 10.992	2.826 µg/mL Interval 2.235 to 3.572

SECONDARY outcome

Timeframe: Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=151 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 1, M0	9.4 Titers Interval 7.7 to 11.5	7.1 Titers Interval 6.2 to 8.2	9.2 Titers Interval 7.7 to 11.0
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 1, M3/M4	1143.7 Titers Interval 952.7 to 1372.9	1328.9 Titers Interval 1137.6 to 1552.4	533.6 Titers Interval 469.5 to 606.4
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 2, M0	6.3 Titers Interval 5.5 to 7.2	5 Titers Interval 4.6 to 5.5	6.9 Titers Interval 6.0 to 8.0
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 2, M3/M4	416.2 Titers Interval 344.5 to 502.8	458.6 Titers Interval 385.6 to 545.5	186.4 Titers Interval 160.4 to 216.5
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 3, M0	5.8 Titers Interval 5.0 to 6.8	4.9 Titers Interval 4.3 to 5.6	5.7 Titers Interval 5.1 to 6.4
Anti-polio Types 1, 2 and 3 Antibody Titers Anti-polio 3, M3/M4	1478.8 Titers Interval 1210.6 to 1806.5	1411.6 Titers Interval 1175.3 to 1695.3	820.7 Titers Interval 820.7 to 964.4

SECONDARY outcome

Timeframe: Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Population: The analysis was performed on the ATP cohort for immunogenicity, which included a subset of evaluable subjects for whom data concerning immunogenicity outcome measures and assay results for antibodies against at least one study vaccine antigen component were available.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=147 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=157 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=151 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M0	2.9 EL.U/mL Interval 2.8 to 3.1	2.7 EL.U/mL Interval 2.6 to 2.8	2.8 EL.U/mL Interval 2.6 to 2.9
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT, M3/M4	108.7 EL.U/mL Interval 99.2 to 119.1	114.7 EL.U/mL Interval 105.4 to 124.8	97.1 EL.U/mL Interval 88.3 to 106.8
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M0	2.9 EL.U/mL Interval 2.7 to 3.1	2.6 EL.U/mL Interval 2.5 to 2.7	2.9 EL.U/mL Interval 2.7 to 3.1
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA, M3/M4	87.7 EL.U/mL Interval 79.9 to 96.3	87.6 EL.U/mL Interval 79.6 to 96.4	76.3 EL.U/mL Interval 68.5 to 85.0
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M0	2.6 EL.U/mL Interval 2.5 to 2.7	2.6 EL.U/mL Interval 2.5 to 2.6	2.5 EL.U/mL Interval 2.5 to 2.6
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN, M3/M4	44.8 EL.U/mL Interval 42.0 to 47.9	43.7 EL.U/mL Interval 41.3 to 46.3	43.2 EL.U/mL Interval 39.8 to 47.0

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

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

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 1	65 Participants	64 Participants	83 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 1	16 Participants	19 Participants	15 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 1	8 Participants	9 Participants	9 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 2	43 Participants	50 Participants	58 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 2	14 Participants	19 Participants	13 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 2	6 Participants	8 Participants	8 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 3	39 Participants	41 Participants	39 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 3	10 Participants	11 Participants	8 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 3	5 Participants	8 Participants	6 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Across doses	90 Participants	91 Participants	102 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Across doses	28 Participants	34 Participants	26 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Across doses	14 Participants	17 Participants	19 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented, who had their symptom sheets filled in.

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Subjects With Any Solicited General Symptoms Any Fever/Axillary, Across doses	217 Participants	217 Participants	183 Participants
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 1	95 Participants	80 Participants	69 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 1	123 Participants	120 Participants	116 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite, Dose 1	77 Participants	86 Participants	76 Participants
Number of Subjects With Any Solicited General Symptoms Any Fever/Axillary, Dose 1	137 Participants	152 Participants	103 Participants
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 2	53 Participants	47 Participants	53 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 2	96 Participants	100 Participants	103 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite, Dose 2	69 Participants	72 Participants	59 Participants
Number of Subjects With Any Solicited General Symptoms Any Fever/Axillary, Dose 2	131 Participants	144 Participants	102 Participants
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Dose 3	43 Participants	32 Participants	28 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability, Dose 3	77 Participants	70 Participants	61 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite, Dose 3	65 Participants	57 Participants	36 Participants
Number of Subjects With Any Solicited General Symptoms Any Fever/Axillary, Dose 3	93 Participants	82 Participants	75 Participants
Number of Subjects With Any Solicited General Symptoms Any Drowsiness, Across doses	124 Participants	102 Participants	99 Participants
Number of Subjects With Any Solicited General Symptoms Any Irritability, Across doses	171 Participants	166 Participants	163 Participants
Number of Subjects With Any Solicited General Symptoms Any Loss of appetite, Across doses	131 Participants	136 Participants	114 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period after any dose

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

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.

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Subjects With Unsolicited Adverse Events (AEs)	98 Participants	114 Participants	110 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 to Month 4/5)

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

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Measure	Infanrix-IPV+Hib 1 Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 Participants Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Number of Subjects With Serious Adverse Events (SAEs)	6 Participants	3 Participants	4 Participants

Adverse Events

Infanrix-IPV+Hib 1 Group

Serious events: 6 serious events

Other events: 279 other events

Deaths: 1 deaths

Infanrix-IPV+Hib 2 Group

Serious events: 3 serious events

Other events: 277 other events

Deaths: 0 deaths

Infanrix-Hib+Poliorix Group

Serious events: 4 serious events

Other events: 272 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infanrix-IPV+Hib 1 Group n=330 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
Gastrointestinal disorders Enteritis	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.31% 1/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Gastrointestinal disorders Diarrhoea	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Hepatobiliary disorders Hepatitis neonatal	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.31% 1/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Metabolism and nutrition disorders Hypokalaemia	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Metabolism and nutrition disorders Malnutrition	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Infections and infestations Bronchopneumonia	0.91% 3/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.62% 2/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Infections and infestations Bronchitis	0.61% 2/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Infections and infestations Pharyngitis	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Infections and infestations Pneumonia	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Infections and infestations Septic shock	0.30% 1/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	0.00% 0/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).

Other adverse events

Measure	Infanrix-IPV+Hib 1 Group n=330 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-IPV+Hib 2 Group n=324 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.	Infanrix-Hib+Poliorix Group n=330 participants at risk Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix-Hib vaccine co-administered with Poliorix vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
General disorders Pyrexia	5.8% 19/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	7.4% 24/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	5.2% 17/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Pain	27.3% 90/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	28.1% 91/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	30.9% 102/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Redness	8.5% 28/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	10.5% 34/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	7.9% 26/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Swelling	4.2% 14/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	5.2% 17/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	5.8% 19/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Drowsiness	37.6% 124/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	31.5% 102/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	30.0% 99/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Irritability	51.8% 171/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	51.2% 166/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	49.4% 163/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Loss of appetite	39.7% 131/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	42.0% 136/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	34.5% 114/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Fever (Axillary)	65.8% 217/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	67.0% 217/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	55.5% 183/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
Gastrointestinal disorders Diarrhoea	7.0% 23/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	6.8% 22/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	10.0% 33/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).
General disorders Nasopharyngitis	12.7% 42/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	14.2% 46/324 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).	15.2% 50/330 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).

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