Trial Outcomes & Findings for Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine (NCT NCT01353703)

NCT ID: NCT01353703

Last Updated: 2020-01-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 224 participants
• Primary outcome timeframe: One month post Dose 3 (Month 3 or Month 5)
• Results posted on: 2020-01-02

Participant Flow

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 Hexa 6-10-14 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Overall Study STARTED	112	112
Overall Study COMPLETED	111	112
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Infanrix Hexa 6-10-14 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Overall Study Migrated/moved from study area	1	0

Baseline Characteristics

Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

Baseline characteristics by cohort

Measure	Infanrix Hexa 6-10-14 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.	Total n=224 Participants Total of all reporting groups
Age, Continuous	6.7 Weeks STANDARD_DEVIATION 1.04 • n=93 Participants	6.8 Weeks STANDARD_DEVIATION 1.13 • n=4 Participants	6.75 Weeks STANDARD_DEVIATION 1.08 • n=27 Participants
Sex: Female, Male Female	52 Participants n=93 Participants	52 Participants n=4 Participants	104 Participants n=27 Participants
Sex: Female, Male Male	60 Participants n=93 Participants	60 Participants n=4 Participants	120 Participants n=27 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage	112 Participants n=93 Participants	112 Participants n=4 Participants	224 Participants n=27 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-D	105 Participants	106 Participants
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens Anti-T	105 Participants	106 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=101 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Hepatitis B (HBs)	101 Participants	104 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=99 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=99 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens Anti-Polio 1	99 Participants	99 Participants
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens Anti-Polio 2	77 Participants	88 Participants
Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens Anti-Polio 3	73 Participants	79 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens	104 Participants	105 Participants

PRIMARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed and for whom pre-vaccination data was available for the considered assay.

Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=89 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=90 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-PT, S-	61 Participants	67 Participants
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-PT, S+	44 Participants	36 Participants
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-FHA, S-	12 Participants	12 Participants
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-FHA, S+	86 Participants	88 Participants
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-PRN, S-	86 Participants	89 Participants
Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Anti-PRN, S+	18 Participants	14 Participants

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-D and Anti-T Antibody Concentrations Anti-D	2.334 IU/mL Interval 2.049 to 2.659	3.726 IU/mL Interval 3.26 to 4.258
Anti-D and Anti-T Antibody Concentrations Anti-T	3.307 IU/mL Interval 2.925 to 3.739	4.904 IU/mL Interval 4.378 to 5.493

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=101 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-HBs Antibody Concentrations	1695.7 mIU/mL Interval 1395.2 to 2060.9	3314.5 mIU/mL Interval 2645.2 to 4153.1

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=99 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=99 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-Polio Types 1, 2, 3 Antibody Titers Anti-Polio 1	884.3 Titers Interval 666.6 to 1173.1	1799.2 Titers Interval 1429.0 to 2265.5
Anti-Polio Types 1, 2, 3 Antibody Titers Anti-Polio 2	840.2 Titers Interval 616.9 to 1144.2	2138.7 Titers Interval 1658.1 to 2758.7
Anti-Polio Types 1, 2, 3 Antibody Titers Anti-Polio 3	923.7 Titers Interval 691.9 to 1233.2	2245.5 Titers Interval 1866.1 to 2702.1

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-PRP Antibody Concentrations	2.697 µg/mL Interval 2.176 to 3.343	5.404 µg/mL Interval 4.168 to 7.006

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	107.3 EL.U/mL Interval 96.6 to 119.1	108.2 EL.U/mL Interval 97.4 to 120.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	293.7 EL.U/mL Interval 259.4 to 332.6	369.3 EL.U/mL Interval 335.5 to 406.5
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	224.4 EL.U/mL Interval 194.2 to 259.3	243.6 EL.U/mL Interval 213.2 to 278.4

SECONDARY outcome

Timeframe: One month post Dose 3 (Month 3 or Month 5)

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=106 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT	105 Participants	106 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	105 Participants	106 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	105 Participants	106 Participants

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=97 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=102 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-Polio 1	71 Participants	70 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-Polio 2	38 Participants	42 Participants
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Anti-Polio 3	23 Participants	30 Participants

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=104 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PT	44 Participants	37 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-FHA	89 Participants	90 Participants
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Anti-PRN	19 Participants	15 Participants

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=80 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=81 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Seroprotected Subjects Against Anti-HBs Antigens	14 Participants	13 Participants

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=97 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=102 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-Polio Types 1, 2 and 3 Antibody Titers Anti-Polio 1	53.5 Titers Interval 33.5 to 85.3	31.9 Titers Interval 21.5 to 47.2
Anti-Polio Types 1, 2 and 3 Antibody Titers Anti-Polio 2	32.5 Titers Interval 19.2 to 55.0	36.2 Titers Interval 22.2 to 59.0
Anti-Polio Types 1, 2 and 3 Antibody Titers Anti-Polio 3	8 Titers Interval 5.9 to 10.8	11.9 Titers Interval 8.3 to 17.0

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=105 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=104 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PT	5 EL.U/mL Interval 4.2 to 6.0	4.6 EL.U/mL Interval 3.8 to 5.6
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-FHA	18.7 EL.U/mL Interval 15.0 to 23.3	20.1 EL.U/mL Interval 16.1 to 25.2
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Anti-PRN	3.4 EL.U/mL Interval 2.9 to 3.9	3.2 EL.U/mL Interval 2.8 to 3.7

SECONDARY outcome

Timeframe: At Month 0

Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, including all evaluable subjects for whom data was available for the considered timepoint and assay assessed.

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

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=80 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=81 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Anti-HBs Antibody Concentrations	5.9 mIU/mL Interval 4.2 to 8.3	5.6 mIU/mL Interval 4.1 to 7.7

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.

Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=111 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 1	23 Participants	11 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 1	3 Participants	1 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 1	7 Participants	4 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 2	13 Participants	3 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 2	0 Participants	1 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 2	2 Participants	2 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Dose 3	10 Participants	6 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Dose 3	3 Participants	0 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Dose 3	2 Participants	3 Participants
Number of Subjects With Any Solicited Local Symptoms Any Pain, Across doses	28 Participants	15 Participants
Number of Subjects With Any Solicited Local Symptoms Any Swelling, Across doses	6 Participants	2 Participants
Number of Subjects With Any Solicited Local Symptoms Any Redness, Across doses	8 Participants	9 Participants

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period after each dose and across doses: Up to Month 2 (Infanrix Hexa 6-10-14 Group) or Month 4 (Infanrix Hexa 2-4-6 Group)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine, for whom data were available and who had the symptoms sheet filled in.

Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and temperature [defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)]. Any = incidence of any particular symptom regardless of intensity grade or relationship to study vaccination.

Outcome measures

Measure	Infanrix Hexa 6-10-14 Group n=111 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Subjects With Solicited General Symptoms Any Drowsiness, Dose 1	0 Participants	2 Participants
Number of Subjects With Solicited General Symptoms Any Irritability/fussiness, Dose 1	8 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Any Loss of appetite, Dose 1	1 Participants	3 Participants
Number of Subjects With Solicited General Symptoms Any Temperature/(Axillary), Dose 1	10 Participants	7 Participants
Number of Subjects With Solicited General Symptoms Any Drowsiness, Dose 2	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Any Irritability/fussiness, Dose 2	2 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Any Loss of appetite, Dose 2	0 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Any Temperature/(Axillary), Dose 2	5 Participants	7 Participants
Number of Subjects With Solicited General Symptoms Any Drowsiness, Dose 3	0 Participants	0 Participants
Number of Subjects With Solicited General Symptoms Any Irritability/fussiness, Dose 3	3 Participants	3 Participants
Number of Subjects With Solicited General Symptoms Any Loss of appetite, Dose 3	1 Participants	1 Participants
Number of Subjects With Solicited General Symptoms Any Temperature/(Axillary), Dose 3	3 Participants	6 Participants
Number of Subjects With Solicited General Symptoms Any Drowsiness, Across doses	0 Participants	2 Participants
Number of Subjects With Solicited General Symptoms Any Irritability/fussiness, Across doses	13 Participants	10 Participants
Number of Subjects With Solicited General Symptoms Any Loss of appetite, Across doses	2 Participants	5 Participants
Number of Subjects With Solicited General Symptoms Any Temperature/(Axillary), Across doses	17 Participants	17 Participants

SECONDARY outcome

Timeframe: During the 31-day (Days 0-30) post-vaccination period: Up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group)

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

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 Hexa 6-10-14 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Subjects With Unsolicited Adverse Events (AEs)	40 Participants	25 Participants

SECONDARY outcome

Timeframe: During the entire study period (from Month 0 up to Month 3 (Infanrix Hexa 6-10-14 Group) or Month 5 (Infanrix Hexa 2-4-6 Group))

Population: The analysis was performed on the Total Vaccinated Cohort, which included all subjects who received at least one dose of the study vaccine and for whom data were available.

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 Hexa 6-10-14 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 Participants Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Number of Subjects With Serious Adverse Events (SAEs)	2 Participants	3 Participants

Adverse Events

Infanrix Hexa 6-10-14 Group

Serious events: 2 serious events

Other events: 45 other events

Deaths: 0 deaths

Infanrix Hexa 2-4-6 Group

Serious events: 3 serious events

Other events: 36 other events

Deaths: 0 deaths

Serious adverse events

Measure	Infanrix Hexa 6-10-14 Group n=112 participants at risk Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 participants at risk Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Infections and infestations Lower respiratory tract infection	0.00% 0/112 • Solicited 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 to Month 3 or Month 5).	1.8% 2/112 • Solicited 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 to Month 3 or Month 5).
Infections and infestations Bronchiolitis	0.89% 1/112 • Solicited 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 to Month 3 or Month 5).	0.00% 0/112 • Solicited 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 to Month 3 or Month 5).
Infections and infestations Pneumonia	0.89% 1/112 • Solicited 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 to Month 3 or Month 5).	0.89% 1/112 • Solicited 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 to Month 3 or Month 5).

Other adverse events

Measure	Infanrix Hexa 6-10-14 Group n=112 participants at risk Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 6, 10 and 14 weeks of age, administered intramuscularly in the right side of the thigh.	Infanrix Hexa 2-4-6 Group n=112 participants at risk Healthy male or female subjects, aged between and including 6 and 10 weeks of age at the time of first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 4 and 6 months of age, administered intramuscularly in the right side of the thigh.
Skin and subcutaneous tissue disorders Erythema	5.4% 6/112 • Number of events 6 • Solicited 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 to Month 3 or Month 5).	1.8% 2/112 • Number of events 2 • Solicited 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 to Month 3 or Month 5).
Psychiatric disorders Irritability	11.6% 13/112 • Number of events 13 • Solicited 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 to Month 3 or Month 5).	8.9% 10/112 • Number of events 13 • Solicited 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 to Month 3 or Month 5).
General disorders Pain	25.0% 28/112 • Number of events 46 • Solicited 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 to Month 3 or Month 5).	13.4% 15/112 • Number of events 20 • Solicited 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 to Month 3 or Month 5).
General disorders Pyrexia	16.1% 18/112 • Number of events 19 • Solicited 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 to Month 3 or Month 5).	15.2% 17/112 • Number of events 20 • Solicited 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 to Month 3 or Month 5).
Infections and infestations Rhinitis	3.6% 4/112 • Number of events 5 • Solicited 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 to Month 3 or Month 5).	5.4% 6/112 • Number of events 6 • Solicited 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 to Month 3 or Month 5).
General disorders Swelling	7.1% 8/112 • Number of events 11 • Solicited 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 to Month 3 or Month 5).	8.0% 9/112 • Number of events 9 • Solicited 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 to Month 3 or Month 5).
Infections and infestations Upper respiratory tract infection	16.1% 18/112 • Number of events 23 • Solicited 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 to Month 3 or Month 5).	9.8% 11/112 • Number of events 13 • Solicited 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 to Month 3 or Month 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