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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01353703
Recruitment Status : Completed
First Posted : May 16, 2011
Results First Posted : January 25, 2019
Last Update Posted : January 2, 2020
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Poliomyelitis
Tetanus
Acellular Pertussis
Haemophilus Influenzae Type b
Diphtheria
Hepatitis B
Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
Intervention Biological: Infanrix hexa™
Enrollment 224
Recruitment Details  
Pre-assignment Details During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 112 112
Completed 111 112
Not Completed 1 0
Reason Not Completed
Migrated/moved from study area             1             0
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 112 112 224
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Weeks
Number Analyzed 112 participants 112 participants 224 participants
6.7  (1.04) 6.8  (1.13) 6.75  (1.08)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 112 participants 112 participants 224 participants
Female
52
  46.4%
52
  46.4%
104
  46.4%
Male
60
  53.6%
60
  53.6%
120
  53.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Asian-Central/South Asian heritage Number Analyzed 112 participants 112 participants 224 participants
112
 100.0%
112
 100.0%
224
 100.0%
1.Primary Outcome
Title Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Antigens
Hide Description 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).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-D
105
 100.0%
106
 100.0%
Anti-T
105
 100.0%
106
 100.0%
2.Primary Outcome
Title Number of Seroprotected Subjects Against Hepatitis B (HBs)
Hide Description A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 101 105
Measure Type: Count of Participants
Unit of Measure: Participants
101
 100.0%
104
  99.0%
3.Primary Outcome
Title Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens
Hide Description 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).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 99 99
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-Polio 1 Number Analyzed 99 participants 99 participants
99
 100.0%
99
 100.0%
Anti-Polio 2 Number Analyzed 77 participants 88 participants
77
 100.0%
88
 100.0%
Anti-Polio 3 Number Analyzed 74 participants 79 participants
73
  98.6%
79
 100.0%
4.Primary Outcome
Title Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens
Hide Description A seroprotected subject was defined as a subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Measure Type: Count of Participants
Unit of Measure: Participants
104
  99.0%
105
  99.1%
5.Primary Outcome
Title Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Hide Description 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.
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 89 90
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT, S- Number Analyzed 61 participants 67 participants
61
 100.0%
67
 100.0%
Anti-PT, S+ Number Analyzed 44 participants 37 participants
44
 100.0%
36
  97.3%
Anti-FHA, S- Number Analyzed 12 participants 12 participants
12
 100.0%
12
 100.0%
Anti-FHA, S+ Number Analyzed 89 participants 90 participants
86
  96.6%
88
  97.8%
Anti-PRN, S- Number Analyzed 86 participants 89 participants
86
 100.0%
89
 100.0%
Anti-PRN, S+ Number Analyzed 19 participants 15 participants
18
  94.7%
14
  93.3%
6.Secondary Outcome
Title Anti-D and Anti-T Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Geometric Mean (95% Confidence Interval)
Unit of Measure: IU/mL
Anti-D
2.334
(2.049 to 2.659)
3.726
(3.26 to 4.258)
Anti-T
3.307
(2.925 to 3.739)
4.904
(4.378 to 5.493)
7.Secondary Outcome
Title Anti-HBs Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 101 105
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
1695.7
(1395.2 to 2060.9)
3314.5
(2645.2 to 4153.1)
8.Secondary Outcome
Title Anti-Polio Types 1, 2, 3 Antibody Titers
Hide Description Antibody titers were presented as geometric mean titers (GMTs).
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 99 99
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 Number Analyzed 99 participants 99 participants
884.3
(666.6 to 1173.1)
1799.2
(1429 to 2265.5)
Anti-Polio 2 Number Analyzed 77 participants 88 participants
840.2
(616.9 to 1144.2)
2138.7
(1658.1 to 2758.7)
Anti-Polio 3 Number Analyzed 74 participants 79 participants
923.7
(691.9 to 1233.2)
2245.5
(1866.1 to 2702.1)
9.Secondary Outcome
Title Anti-PRP Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
2.697
(2.176 to 3.343)
5.404
(4.168 to 7.006)
10.Secondary Outcome
Title Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT
107.3
(96.6 to 119.1)
108.2
(97.4 to 120.2)
Anti-FHA
293.7
(259.4 to 332.6)
369.3
(335.5 to 406.5)
Anti-PRN
224.4
(194.2 to 259.3)
243.6
(213.2 to 278.4)
11.Secondary Outcome
Title Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Hide Description A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame One month post Dose 3 (Month 3 or Month 5)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 106
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT
105
 100.0%
106
 100.0%
Anti-FHA
105
 100.0%
106
 100.0%
Anti-PRN
105
 100.0%
106
 100.0%
12.Secondary Outcome
Title Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens
Hide Description 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).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 97 102
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-Polio 1 Number Analyzed 97 participants 102 participants
71
  73.2%
70
  68.6%
Anti-Polio 2 Number Analyzed 56 participants 55 participants
38
  67.9%
42
  76.4%
Anti-Polio 3 Number Analyzed 88 participants 91 participants
23
  26.1%
30
  33.0%
13.Secondary Outcome
Title Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Hide Description A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 104
Measure Type: Count of Participants
Unit of Measure: Participants
Anti-PT Number Analyzed 105 participants 104 participants
44
  41.9%
37
  35.6%
Anti-FHA Number Analyzed 101 participants 102 participants
89
  88.1%
90
  88.2%
Anti-PRN Number Analyzed 105 participants 104 participants
19
  18.1%
15
  14.4%
14.Secondary Outcome
Title Number of Seroprotected Subjects Against Anti-HBs Antigens
Hide Description A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 80 81
Measure Type: Count of Participants
Unit of Measure: Participants
14
  17.5%
13
  16.0%
15.Secondary Outcome
Title Anti-Polio Types 1, 2 and 3 Antibody Titers
Hide Description Antibody titers were presented as geometric mean titers (GMTs).
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 97 102
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
Anti-Polio 1 Number Analyzed 97 participants 102 participants
53.5
(33.5 to 85.3)
31.9
(21.5 to 47.2)
Anti-Polio 2 Number Analyzed 56 participants 55 participants
32.5
(19.2 to 55)
36.2
(22.2 to 59)
Anti-Polio 3 Number Analyzed 88 participants 91 participants
8
(5.9 to 10.8)
11.9
(8.3 to 17)
16.Secondary Outcome
Title Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 105 104
Geometric Mean (95% Confidence Interval)
Unit of Measure: EL.U/mL
Anti-PT Number Analyzed 105 participants 104 participants
5
(4.2 to 6)
4.6
(3.8 to 5.6)
Anti-FHA Number Analyzed 101 participants 102 participants
18.7
(15 to 23.3)
20.1
(16.1 to 25.2)
Anti-PRN Number Analyzed 105 participants 104 participants
3.4
(2.9 to 3.9)
3.2
(2.8 to 3.7)
17.Secondary Outcome
Title Anti-HBs Antibody Concentrations
Hide Description Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Time Frame At Month 0
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 80 81
Geometric Mean (95% Confidence Interval)
Unit of Measure: mIU/mL
5.9
(4.2 to 8.3)
5.6
(4.1 to 7.7)
18.Secondary Outcome
Title Number of Subjects With Any Solicited Local Symptoms
Hide Description Assessed solicited local symptoms were pain, redness and swelling. Any = incidence of any particular symptom regardless of intensity grade.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Pain, Dose 1
23
  20.7%
11
   9.8%
Any Redness, Dose 1
3
   2.7%
1
   0.9%
Any Swelling, Dose 1
7
   6.3%
4
   3.6%
Any Pain, Dose 2
13
  11.7%
3
   2.7%
Any Redness, Dose 2
0
   0.0%
1
   0.9%
Any Swelling, Dose 2
2
   1.8%
2
   1.8%
Any Pain, Dose 3
10
   9.0%
6
   5.4%
Any Redness, Dose 3
3
   2.7%
0
   0.0%
Any Swelling, Dose 3
2
   1.8%
3
   2.7%
Any Pain, Across doses
28
  25.2%
15
  13.4%
Any Swelling, Across doses
6
   5.4%
2
   1.8%
Any Redness, Across doses
8
   7.2%
9
   8.0%
19.Secondary Outcome
Title Number of Subjects With Solicited General Symptoms
Hide Description 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.
Time Frame 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 111 112
Measure Type: Count of Participants
Unit of Measure: Participants
Any Drowsiness, Dose 1
0
   0.0%
2
   1.8%
Any Irritability/fussiness, Dose 1
8
   7.2%
5
   4.5%
Any Loss of appetite, Dose 1
1
   0.9%
3
   2.7%
Any Temperature/(Axillary), Dose 1
10
   9.0%
7
   6.3%
Any Drowsiness, Dose 2
0
   0.0%
0
   0.0%
Any Irritability/fussiness, Dose 2
2
   1.8%
5
   4.5%
Any Loss of appetite, Dose 2
0
   0.0%
1
   0.9%
Any Temperature/(Axillary), Dose 2
5
   4.5%
7
   6.3%
Any Drowsiness, Dose 3
0
   0.0%
0
   0.0%
Any Irritability/fussiness, Dose 3
3
   2.7%
3
   2.7%
Any Loss of appetite, Dose 3
1
   0.9%
1
   0.9%
Any Temperature/(Axillary), Dose 3
3
   2.7%
6
   5.4%
Any Drowsiness, Across doses
0
   0.0%
2
   1.8%
Any Irritability/fussiness, Across doses
13
  11.7%
10
   8.9%
Any Loss of appetite, Across doses
2
   1.8%
5
   4.5%
Any Temperature/(Axillary), Across doses
17
  15.3%
17
  15.2%
20.Secondary Outcome
Title Number of Subjects With Unsolicited Adverse Events (AEs)
Hide Description An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time Frame During the 31-day (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)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 112 112
Measure Type: Count of Participants
Unit of Measure: Participants
40
  35.7%
25
  22.3%
21.Secondary Outcome
Title Number of Subjects With Serious Adverse Events (SAEs)
Hide Description 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.
Time Frame 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))
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 112 112
Measure Type: Count of Participants
Unit of Measure: Participants
2
   1.8%
3
   2.7%
Time Frame 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).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/112 (0.00%)      0/112 (0.00%)    
Hide Serious Adverse Events
Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/112 (1.79%)      3/112 (2.68%)    
Infections and infestations     
Lower respiratory tract infection  1  0/112 (0.00%)  2/112 (1.79%) 
Bronchiolitis  1  1/112 (0.89%)  0/112 (0.00%) 
Pneumonia  1  1/112 (0.89%)  1/112 (0.89%) 
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Infanrix Hexa 6-10-14 Group Infanrix Hexa 2-4-6 Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   45/112 (40.18%)      36/112 (32.14%)    
General disorders     
Pain  1  28/112 (25.00%)  46 15/112 (13.39%)  20
Pyrexia  1  18/112 (16.07%)  19 17/112 (15.18%)  20
Swelling  1  8/112 (7.14%)  11 9/112 (8.04%)  9
Infections and infestations     
Rhinitis  1  4/112 (3.57%)  5 6/112 (5.36%)  6
Upper respiratory tract infection  1  18/112 (16.07%)  23 11/112 (9.82%)  13
Psychiatric disorders     
Irritability  1  13/112 (11.61%)  13 10/112 (8.93%)  13
Skin and subcutaneous tissue disorders     
Erythema  1  6/112 (5.36%)  6 2/112 (1.79%)  2
1
Term from vocabulary, MedDRA 18.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Publications:
Lalwani SK et al. (2016) Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants. Hum Vaccin Immunother. 15:0. [Epub ahead of print].
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01353703    
Other Study ID Numbers: 111157
2013-003427-10 ( EudraCT Number )
First Submitted: May 12, 2011
First Posted: May 16, 2011
Results First Submitted: May 26, 2017
Results First Posted: January 25, 2019
Last Update Posted: January 2, 2020