Trial Outcomes & Findings for Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine (NCT NCT00627458)
NCT ID: NCT00627458
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
PHASE2
Target enrollment
403 participants
Primary outcome timeframe
Before the booster administration (At Month 0)
Results posted on
2018-06-06
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 PF Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Overall Study
STARTED
|
127
|
137
|
139
|
|
Overall Study
COMPLETED
|
123
|
130
|
133
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
6
|
Reasons for withdrawal
| Measure |
Infanrix Hexa PF Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Overall Study
Migrated from study area
|
1
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
5
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Baseline characteristics by cohort
| Measure |
Infanrix Hexa PF Group
n=127 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PC Group
n=137 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Total
n=403 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
17.9 Months
STANDARD_DEVIATION 1.12 • n=39 Participants
|
18 Months
STANDARD_DEVIATION 1.03 • n=41 Participants
|
17.8 Months
STANDARD_DEVIATION 1.11 • n=35 Participants
|
17.90 Months
STANDARD_DEVIATION 1.09 • n=31 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=39 Participants
|
66 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
181 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=39 Participants
|
71 Participants
n=41 Participants
|
80 Participants
n=35 Participants
|
222 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Caucasian/European heritage
|
125 Participants
n=39 Participants
|
134 Participants
n=41 Participants
|
135 Participants
n=35 Participants
|
394 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White-Arabic/North African heritage
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Not specified
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
7 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Before the booster administration (At Month 0)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
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 Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D
|
35 Participants
|
—
|
22 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T
|
103 Participants
|
—
|
93 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D
|
118 Participants
|
—
|
112 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T
|
118 Participants
|
—
|
113 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti-HBs ≥ 10 mIU/mL
|
112 Participants
|
—
|
106 Participants
|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti HBs ≥ 100 mIU/mL
|
54 Participants
|
—
|
55 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=118 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti-HBs ≥ 10 mIU/mL
|
117 Participants
|
—
|
110 Participants
|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti HBs ≥ 100 mIU/mL
|
113 Participants
|
—
|
105 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 1
|
76 Participants
|
—
|
67 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 2
|
51 Participants
|
—
|
48 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 3
|
77 Participants
|
—
|
58 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 1
|
117 Participants
|
—
|
110 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 2
|
117 Participants
|
—
|
110 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 3
|
117 Participants
|
—
|
111 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-PT
|
81 Participants
|
—
|
80 Participants
|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-FHA
|
107 Participants
|
—
|
106 Participants
|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-PRN
|
86 Participants
|
—
|
81 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected 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 PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-PT
|
118 Participants
|
—
|
111 Participants
|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-FHA
|
118 Participants
|
—
|
112 Participants
|
|
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Anti-PRN
|
117 Participants
|
—
|
113 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 0.15μg/mL
|
87 Participants
|
—
|
71 Participants
|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 1.0μg/mL
|
23 Participants
|
—
|
15 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 1.0 µg/mL
|
117 Participants
|
—
|
111 Participants
|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 0.15 µg/mL
|
119 Participants
|
—
|
112 Participants
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) \[i.e. with concentrations lower than (\<) the cut-off value\] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) \[i.e. with concentrations greater than (\>) the cut-off value).
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=116 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, S-
|
30 Participants
|
—
|
29 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, Total
|
110 Participants
|
—
|
108 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, S-
|
30 Participants
|
—
|
31 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, S+
|
85 Participants
|
—
|
81 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, S+
|
81 Participants
|
—
|
78 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, Total
|
111 Participants
|
—
|
107 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, S-
|
4 Participants
|
—
|
4 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, S+
|
106 Participants
|
—
|
104 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, Total
|
115 Participants
|
—
|
112 Participants
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
0.069 IU/mL
Interval 0.062 to 0.076
|
—
|
0.064 IU/mL
Interval 0.058 to 0.071
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
0.248 IU/mL
Interval 0.213 to 0.289
|
—
|
0.216 IU/mL
Interval 0.184 to 0.254
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D
|
2.242 IU/mL
Interval 1.868 to 2.689
|
—
|
2.237 IU/mL
Interval 1.877 to 2.666
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T
|
9.136 IU/mL
Interval 7.838 to 10.648
|
—
|
9.799 IU/mL
Interval 8.39 to 11.444
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT
|
7 EL.U/mL
Interval 6.1 to 8.1
|
—
|
7.8 EL.U/mL
Interval 6.7 to 9.1
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA
|
22.1 EL.U/mL
Interval 18.5 to 26.2
|
—
|
21.7 EL.U/mL
Interval 18.1 to 25.9
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN
|
8.7 EL.U/mL
Interval 7.3 to 10.2
|
—
|
8.6 EL.U/mL
Interval 7.1 to 10.3
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PT
|
117.1 EL.U/mL
Interval 101.5 to 135.0
|
—
|
150.9 EL.U/mL
Interval 132.9 to 171.2
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-FHA
|
533.7 EL.U/mL
Interval 463.0 to 615.1
|
—
|
609.6 EL.U/mL
Interval 534.1 to 695.7
|
|
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Anti-PRN
|
311.7 EL.U/mL
Interval 260.3 to 373.2
|
—
|
308.5 EL.U/mL
Interval 261.3 to 364.2
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-HBs Antibody Concentrations
|
86.2 mIU/mL
Interval 67.8 to 109.6
|
—
|
84.3 mIU/mL
Interval 65.7 to 108.2
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=118 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-HBs Antibody Concentrations
|
3528.1 mIU/mL
Interval 2546.1 to 4888.9
|
—
|
3291.7 mIU/mL
Interval 2373.6 to 4565.0
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 3
|
16 Titers
Interval 12.6 to 20.4
|
—
|
9.5 Titers
Interval 7.9 to 11.6
|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 1
|
15.2 Titers
Interval 12.3 to 18.9
|
—
|
12.9 Titers
Interval 10.3 to 16.3
|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 2
|
8.7 Titers
Interval 7.2 to 10.5
|
—
|
9.1 Titers
Interval 7.3 to 11.3
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=117 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 1
|
942.4 Titers
Interval 734.1 to 1209.7
|
—
|
726.3 Titers
Interval 560.4 to 941.4
|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 2
|
812.9 Titers
Interval 632.8 to 1044.3
|
—
|
712.8 Titers
Interval 529.1 to 960.4
|
|
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Anti-polio 3
|
1145.8 Titers
Interval 891.6 to 1472.5
|
—
|
780 Titers
Interval 591.0 to 1029.3
|
PRIMARY outcome
Timeframe: Before the booster vaccination (At Month 0)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
|
0.314 µg/mL
Interval 0.252 to 0.392
|
—
|
0.249 µg/mL
Interval 0.199 to 0.31
|
PRIMARY outcome
Timeframe: One month after the booster vaccination (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=112 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
|
35.318 µg/mL
Interval 27.447 to 45.445
|
—
|
36.866 µg/mL
Interval 28.61 to 47.504
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D, M0
|
—
|
—
|
40 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-D, M1
|
—
|
—
|
119 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T, M0
|
—
|
—
|
95 Participants
|
|
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Anti-T, M1
|
—
|
—
|
119 Participants
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=118 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti HBs ≥ 100 mIU/mL, M0
|
—
|
—
|
67 Participants
|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti HBs ≥ 100 mIU/mL, M1
|
—
|
—
|
114 Participants
|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti-HBs ≥ 10 mIU/mL, M0
|
—
|
—
|
106 Participants
|
|
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Anti-HBs ≥ 10 mIU/mL, M1
|
—
|
—
|
118 Participants
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 1, M0
|
—
|
—
|
84 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 1, M1
|
—
|
—
|
112 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 2, M0
|
—
|
—
|
56 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 2, M1
|
—
|
—
|
112 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 3, M0
|
—
|
—
|
82 Participants
|
|
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Anti-polio 3, M1
|
—
|
—
|
113 Participants
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected 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 PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-PT, M1
|
—
|
—
|
119 Participants
|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-FHA, M0
|
—
|
—
|
109 Participants
|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-FHA, M1
|
—
|
—
|
119 Participants
|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-PT, M0
|
—
|
—
|
93 Participants
|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-PRN, M0
|
—
|
—
|
99 Participants
|
|
Number of Seroprotected Subjects Against PT, FHA and PRN
Anti-PRN, M1
|
—
|
—
|
119 Participants
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 0.15 μg/mL, M0
|
—
|
—
|
92 Participants
|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 0.15 μg/mL, M1
|
—
|
—
|
119 Participants
|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 1.0 μg/mL, M0
|
—
|
—
|
32 Participants
|
|
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Anti-PRP ≥ 1.0 μg/mL, M1
|
—
|
—
|
118 Participants
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, M1
|
—
|
—
|
10.833 IU/mL
Interval 9.505 to 12.347
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, M0
|
—
|
—
|
0.084 IU/mL
Interval 0.073 to 0.097
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-D, M1
|
—
|
—
|
3.952 IU/mL
Interval 3.365 to 4.642
|
|
Anti-D and Anti-T Antibody Concentrations
Anti-T, M0
|
—
|
—
|
0.261 IU/mL
Interval 0.219 to 0.31
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PT, M0
|
—
|
—
|
8.9 EL.U/mL
Interval 7.7 to 10.3
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PT, M1
|
—
|
—
|
153.7 EL.U/mL
Interval 135.1 to 174.9
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-FHA, M0
|
—
|
—
|
33.7 EL.U/mL
Interval 27.6 to 41.1
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-FHA, M1
|
—
|
—
|
791.9 EL.U/mL
Interval 708.8 to 884.8
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PRN, M0
|
—
|
—
|
15.3 EL.U/mL
Interval 12.6 to 18.5
|
|
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Anti-PRN, M1
|
—
|
—
|
564.1 EL.U/mL
Interval 489.5 to 650.1
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=118 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-HBs Antibody Concentrations
Anti-HBs, M0
|
—
|
—
|
139.8 mIU/mL
Interval 107.2 to 182.3
|
|
Anti-HBs Antibody Concentrations
Anti-HBs, M1
|
—
|
—
|
6132.7 mIU/mL
Interval 4587.8 to 8197.9
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody titers were presented as geometric mean titers (GMTs).
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=113 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 1, M0
|
—
|
—
|
21.6 Titers
Interval 17.1 to 27.4
|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 1, M1
|
—
|
—
|
1288.8 Titers
Interval 1029.1 to 1614.0
|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 2, M0
|
—
|
—
|
11.8 Titers
Interval 9.2 to 15.0
|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 2, M1
|
—
|
—
|
1231 Titers
Interval 961.0 to 1576.9
|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 3, M0
|
—
|
—
|
21.3 Titers
Interval 16.4 to 27.7
|
|
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Anti-polio 3, M1
|
—
|
—
|
1794.8 Titers
Interval 1426.8 to 2257.7
|
SECONDARY outcome
Timeframe: Before (Month 0) and one month after (Month 1) the booster vaccinationPopulation: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=119 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Anti-PRP Antibody Concentrations
Anti-PRP, M0
|
—
|
—
|
0.487 µg/mL
Interval 0.383 to 0.62
|
|
Anti-PRP Antibody Concentrations
Anti-PRP, M1
|
—
|
—
|
77.087 µg/mL
Interval 60.224 to 98.672
|
SECONDARY outcome
Timeframe: One month after the booster dose (At Month 1)Population: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations \< cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations \> cut-off value).
Outcome measures
| Measure |
Infanrix Hexa PC Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=111 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, S-
|
—
|
—
|
17 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, S+
|
—
|
—
|
93 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PT, Total
|
—
|
—
|
110 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, S-
|
—
|
—
|
0 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, S+
|
—
|
—
|
105 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-FHA, Total
|
—
|
—
|
105 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, S-
|
—
|
—
|
12 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, S+
|
—
|
—
|
98 Participants
|
|
Number of Subjects With a Vaccine Response to PT, FHA and PR
Anti-PRN, Total
|
—
|
—
|
110 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after the booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=136 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=138 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=126 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited Local Symptoms
Any Pain
|
76 Participants
|
82 Participants
|
74 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Redness
|
79 Participants
|
94 Participants
|
66 Participants
|
|
Number of Subjects With Any Solicited Local Symptoms
Any Swelling
|
53 Participants
|
60 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after the booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented and with their symptoms sheet filled in.
Assessed solicited general symptoms were drowsiness, fever \[defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=136 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=138 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=126 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With Any Solicited General Symptoms
Any Drowsiness
|
48 Participants
|
58 Participants
|
50 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Fever (Rectal)
|
34 Participants
|
31 Participants
|
22 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Loss of Appetite
|
46 Participants
|
45 Participants
|
37 Participants
|
|
Number of Subjects With Any Solicited General Symptoms
Any Irritability
|
86 Participants
|
78 Participants
|
68 Participants
|
SECONDARY outcome
Timeframe: During the 31-day (Day 0-30) follow-up period after the booster vaccinationPopulation: 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 Hexa PC Group
n=137 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=127 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs)
|
54 Participants
|
61 Participants
|
51 Participants
|
SECONDARY outcome
Timeframe: From Month 0 to Month 1, during the entire study periodPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Assessed SAEs 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 PC Group
n=137 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=127 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
2 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) follow-up period after the booster vaccinationPopulation: The analysis was performed on the Total Vaccinated Cohort, which included all subjects with at least one vaccine administration documented.
Outcome measures
| Measure |
Infanrix Hexa PC Group
n=137 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PF Group
n=127 Participants
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Number of Subjects Reporting Concomitant Medications
Any concomitant medication
|
111 Participants
|
116 Participants
|
105 Participants
|
|
Number of Subjects Reporting Concomitant Medications
Any antipyretic
|
35 Participants
|
33 Participants
|
34 Participants
|
Adverse Events
Infanrix Hexa PF Group
Serious events: 1 serious events
Other events: 116 other events
Deaths: 0 deaths
Infanrix Hexa PC Group
Serious events: 2 serious events
Other events: 126 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 129 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Infanrix Hexa PF Group
n=127 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PC Group
n=137 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.79%
1/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.73%
1/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.00%
0/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.73%
1/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.00%
0/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Pneumonia adenoviral
|
0.00%
0/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.00%
0/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.72%
1/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
Other adverse events
| Measure |
Infanrix Hexa PF Group
n=127 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Infanrix Hexa PC Group
n=137 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
Control Group
n=139 participants at risk
Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh.
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
6.6%
9/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
0.00%
0/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Pain
|
58.7%
74/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
55.9%
76/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
59.4%
82/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Redness
|
52.4%
66/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
58.1%
79/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
68.1%
94/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Swelling
|
34.9%
44/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
39.0%
53/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
43.5%
60/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Drowsiness
|
39.7%
50/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
35.3%
48/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
42.0%
58/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Fever/(Rectal)
|
17.5%
22/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
25.0%
34/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
22.5%
31/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Irritability
|
54.0%
68/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
63.2%
86/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
56.5%
78/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Loss of appetite
|
29.4%
37/126 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
33.8%
46/136 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
32.6%
45/138 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Pyrexia
|
4.7%
6/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
3.6%
5/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
5.8%
8/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
General disorders
Injection site induration
|
3.9%
5/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
1.5%
2/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
7.2%
10/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
7/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
2.9%
4/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
3.6%
5/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Otitis media
|
3.1%
4/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
5.1%
7/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
10.1%
14/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.1%
9/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
5.8%
8/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
4.3%
6/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
|
Infections and infestations
Rhinitis
|
2.4%
3/127 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
5.8%
8/137 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
6.5%
9/139 • Solicited symptoms: during the 4-day (Days 0-3) period after the booster vaccination. Unsolicited AEs: during the 31-day (Days 0-30) period after the booster vaccination. SAEs: during the entire study period (from Month 0 up to Month 1).
|
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