Trial Outcomes & Findings for Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib (NCT NCT00652951)
NCT ID: NCT00652951
Last Updated: 2019-06-26
Results Overview
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
780 participants
Primary outcome timeframe
At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccine
Results posted on
2019-06-26
Participant Flow
The study included a Primary (PRI) Phase, up to Month 3, followed by a Booster (BST) Phase, up to Month 9.
At screening the following was performed: informed consent was obtained and signed from subjects' parents/guardians, check for inclusion/exclusion criteria and contraindications/precautions was performed as regards to vaccination, and medical history of subjects was collected. Subjects' pre-vaccination body temperature was evaluated.
Participant milestones
| Measure |
Synflorix + Infanrix Hexa Group
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Primary Phase
STARTED
|
260
|
260
|
260
|
|
Primary Phase
COMPLETED
|
260
|
260
|
260
|
|
Primary Phase
NOT COMPLETED
|
0
|
0
|
0
|
|
Booster Phase
STARTED
|
257
|
259
|
258
|
|
Booster Phase
COMPLETED
|
256
|
258
|
258
|
|
Booster Phase
NOT COMPLETED
|
1
|
1
|
0
|
Reasons for withdrawal
| Measure |
Synflorix + Infanrix Hexa Group
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Booster Phase
Adverse event, non-fatal
|
0
|
1
|
0
|
|
Booster Phase
Other
|
1
|
0
|
0
|
Baseline Characteristics
Co-administration of Pneumococcal Conjugate Vaccine With DTPa-IPV-Hib Versus Co-administration With DTPa-HBV-IPV/Hib
Baseline characteristics by cohort
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
Total
n=780 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
7.4 Weeks
STANDARD_DEVIATION 1.2 • n=5 Participants
|
7.6 Weeks
STANDARD_DEVIATION 1.29 • n=7 Participants
|
7.6 Weeks
STANDARD_DEVIATION 1.26 • n=5 Participants
|
7.53 Weeks
STANDARD_DEVIATION 1.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
118 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
384 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
396 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African heritage/African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Asian - Central/South Asian heritage
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic/North African heritage
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian/European heritage
|
258 Participants
n=5 Participants
|
255 Participants
n=7 Participants
|
256 Participants
n=5 Participants
|
769 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · Unspecified
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccinePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-pneumococcal serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) were measured by 22F-inhibition Enzyme-Linked ImmunSorbent Assay (ELISA); presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was greater than or equal to (≥) 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=194 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=189 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=192 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-1
|
1.17 μg/mL
Interval 1.02 to 1.33
|
1.31 μg/mL
Interval 1.16 to 1.48
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-4
|
1.61 μg/mL
Interval 1.41 to 1.84
|
1.59 μg/mL
Interval 1.38 to 1.83
|
2.44 μg/mL
Interval 2.19 to 2.73
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-5
|
2.11 μg/mL
Interval 1.88 to 2.37
|
2.16 μg/mL
Interval 1.92 to 2.43
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-6B
|
0.33 μg/mL
Interval 0.26 to 0.4
|
0.35 μg/mL
Interval 0.28 to 0.43
|
0.41 μg/mL
Interval 0.34 to 0.51
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-7F
|
1.7 μg/mL
Interval 1.52 to 1.9
|
1.77 μg/mL
Interval 1.57 to 1.99
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-9V
|
1.4 μg/mL
Interval 1.2 to 1.63
|
1.47 μg/mL
Interval 1.29 to 1.68
|
2.14 μg/mL
Interval 1.91 to 2.4
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-14
|
3.38 μg/mL
Interval 2.99 to 3.81
|
3.33 μg/mL
Interval 2.93 to 3.78
|
3.64 μg/mL
Interval 3.24 to 4.1
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-18C
|
1.73 μg/mL
Interval 1.45 to 2.05
|
1.07 μg/mL
Interval 0.92 to 1.25
|
2.1 μg/mL
Interval 1.83 to 2.4
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-19F
|
2.07 μg/mL
Interval 1.73 to 2.48
|
1.96 μg/mL
Interval 1.64 to 2.34
|
3.04 μg/mL
Interval 2.71 to 3.42
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, -4, -5, -6B, -7F, -9V, -14, -18C, -19F and -23F) - Primary Vaccination
Anti-23F
|
0.5 μg/mL
Interval 0.41 to 0.6
|
0.54 μg/mL
Interval 0.44 to 0.66
|
1.24 μg/mL
Interval 1.04 to 1.47
|
PRIMARY outcome
Timeframe: At Month 3, one month after the administration of the third dose of pneumococcal conjugate vaccinePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=195 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=189 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=182 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentration Against Protein D (PD) - Primary Vaccination
|
1580 EL.U/mL
Interval 1409.5 to 1771.1
|
1743 EL.U/mL
Interval 1560.2 to 1947.2
|
69.7 EL.U/mL
Interval 63.0 to 77.1
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=194 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=189 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=192 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-1
|
174 Participants
|
176 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-4
|
188 Participants
|
180 Participants
|
189 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-5
|
187 Participants
|
179 Participants
|
0 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-6B
|
122 Participants
|
113 Participants
|
124 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-7F
|
190 Participants
|
186 Participants
|
11 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-9V
|
176 Participants
|
181 Participants
|
184 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-14
|
191 Participants
|
187 Participants
|
192 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-18C
|
183 Participants
|
178 Participants
|
187 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-19F
|
180 Participants
|
174 Participants
|
189 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Primary Vaccination
Anti-23F
|
134 Participants
|
133 Participants
|
171 Participants
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=139 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=135 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=132 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-1
|
20.7 Titers
Interval 15.6 to 27.6
|
20.8 Titers
Interval 15.8 to 27.4
|
4.7 Titers
Interval 4.1 to 5.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-4
|
592.9 Titers
Interval 475.9 to 738.7
|
600.4 Titers
Interval 492.2 to 732.3
|
838.4 Titers
Interval 718.7 to 978.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-5
|
54.8 Titers
Interval 44.0 to 68.4
|
60.1 Titers
Interval 48.2 to 74.8
|
4.2 Titers
Interval 3.9 to 4.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-6B
|
261.3 Titers
Interval 176.0 to 388.0
|
296.4 Titers
Interval 198.0 to 443.7
|
633 Titers
Interval 419.0 to 956.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-7F
|
2063.3 Titers
Interval 1691.7 to 2516.6
|
2136.1 Titers
Interval 1707.9 to 2671.5
|
18.4 Titers
Interval 12.1 to 28.0
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-9V
|
863.6 Titers
Interval 687.6 to 1084.7
|
1277.7 Titers
Interval 1053.3 to 1550.1
|
1194 Titers
Interval 1009.5 to 1412.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-14
|
990.4 Titers
Interval 820.6 to 1195.5
|
1086.4 Titers
Interval 899.6 to 1311.9
|
1373.3 Titers
Interval 1040.4 to 1812.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-18C
|
122.6 Titers
Interval 89.4 to 168.2
|
84.2 Titers
Interval 60.9 to 116.5
|
213.6 Titers
Interval 163.6 to 278.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-19F
|
133 Titers
Interval 98.1 to 180.2
|
143.8 Titers
Interval 108.6 to 190.3
|
39.2 Titers
Interval 30.6 to 50.4
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Primary Vaccination
Opsono-23F
|
847.4 Titers
Interval 626.5 to 1146.3
|
1089 Titers
Interval 800.2 to 1482.0
|
3703.4 Titers
Interval 3119.4 to 4396.8
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Antibody concentrations against the cross- reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=185 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=177 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=183 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.
Anti-6A
|
58 Participants
|
51 Participants
|
41 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Primary Vaccination.
Anti-19A
|
56 Participants
|
50 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-pneumococcal cross-reactive serotypes 6A and 19A antibody concentrations (Anti-6A and -19A) were measured by 22F-inhibition ELISA; presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off for the assay was ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=185 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=177 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=183 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination
Anti-6A
|
0.1 µg/mL
Interval 0.08 to 0.12
|
0.1 µg/mL
Interval 0.09 to 0.12
|
0.08 µg/mL
Interval 0.06 to 0.09
|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Primary Vaccination
Anti-19A
|
0.1 µg/mL
Interval 0.09 to 0.13
|
0.09 µg/mL
Interval 0.08 to 0.11
|
0.08 µg/mL
Interval 0.07 to 0.1
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=135 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=129 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=130 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.
Opsono-6A
|
23.2 Titers
Interval 16.1 to 33.6
|
25.4 Titers
Interval 17.1 to 37.8
|
33 Titers
Interval 21.4 to 50.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Primary Vaccination.
Opsono-19A
|
9 Titers
Interval 6.9 to 11.7
|
8 Titers
Interval 6.3 to 10.2
|
4.9 Titers
Interval 4.4 to 5.4
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=187 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=180 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=189 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination
Anti-diphteria
|
1.475 IU/mL
Interval 1.307 to 1.664
|
1.078 IU/mL
Interval 0.939 to 1.237
|
1.077 IU/mL
Interval 0.949 to 1.222
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Primary Vaccination
Anti-tetanus
|
2.873 IU/mL
Interval 2.622 to 3.147
|
1.702 IU/mL
Interval 1.528 to 1.897
|
0.934 IU/mL
Interval 0.837 to 1.043
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=189 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=179 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=188 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Primary Vaccination
|
2.139 µg/mL
Interval 1.766 to 2.59
|
4.796 µg/mL
Interval 3.829 to 6.007
|
2.219 µg/mL
Interval 1.724 to 2.857
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=187 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=180 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=188 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination
Anti-PT
|
42.7 EL.U/mL
Interval 39.1 to 46.6
|
36.4 EL.U/mL
Interval 33.4 to 39.8
|
40.1 EL.U/mL
Interval 37.0 to 43.6
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination
Anti-FHA
|
145.6 EL.U/mL
Interval 130.4 to 162.5
|
100.8 EL.U/mL
Interval 89.6 to 113.5
|
100.5 EL.U/mL
Interval 89.9 to 112.4
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Primary Vaccination
Anti-PRN
|
97.6 EL.U/mL
Interval 86.8 to 109.7
|
40.1 EL.U/mL
Interval 34.8 to 46.1
|
45.1 EL.U/mL
Interval 39.3 to 51.7
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=111 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=112 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=113 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Primary Vaccination.
|
356.9 mIU/mL
Interval 279.4 to 455.8
|
14 mIU/mL
Interval 11.6 to 16.9
|
11.5 mIU/mL
Interval 9.8 to 13.5
|
SECONDARY outcome
Timeframe: At Month 3, one month after the administration of the third vaccine dosePopulation: The Primary ATP cohort for immunogenicity included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. This included subjects for whom assay results were available for antibodies against at least one study vaccine antigen component post-dose III.
Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=156 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=150 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=149 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.
Anti-polio 1
|
27.2 Titers
Interval 21.7 to 34.1
|
16 Titers
Interval 13.0 to 19.7
|
18.1 Titers
Interval 14.8 to 22.1
|
|
Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.
Anti-polio 2
|
37.1 Titers
Interval 29.1 to 47.4
|
29 Titers
Interval 23.0 to 36.6
|
23.2 Titers
Interval 18.5 to 29.1
|
|
Anti-polio Types 1, 2 and 3 Titers - Primary Vaccination.
Anti-polio 3
|
47.3 Titers
Interval 35.8 to 62.4
|
34.2 Titers
Interval 27.0 to 43.4
|
26.7 Titers
Interval 21.5 to 33.0
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=190 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=198 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=202 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-9V, Month 10
|
188 Participants
|
197 Participants
|
202 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-1, Month 9
|
84 Participants
|
92 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-4, Month 9
|
136 Participants
|
147 Participants
|
148 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-5, Month 9
|
142 Participants
|
152 Participants
|
3 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-6B, Month 9
|
117 Participants
|
127 Participants
|
62 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-7F, Month 9
|
165 Participants
|
164 Participants
|
5 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-9V, Month 9
|
168 Participants
|
168 Participants
|
176 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-14, Month 9
|
170 Participants
|
172 Participants
|
190 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-18C, Month 9
|
152 Participants
|
143 Participants
|
151 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-19F, Month 9
|
149 Participants
|
157 Participants
|
109 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-23F, Month 9
|
123 Participants
|
140 Participants
|
108 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-1, Month 10
|
187 Participants
|
195 Participants
|
7 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-4, Month 10
|
187 Participants
|
194 Participants
|
198 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-5, Month 10
|
185 Participants
|
191 Participants
|
4 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-6B, Month 10
|
176 Participants
|
181 Participants
|
192 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-7F, Month 10
|
189 Participants
|
198 Participants
|
8 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-14, Month 10
|
190 Participants
|
197 Participants
|
198 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-18C, Month 10
|
188 Participants
|
196 Participants
|
200 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-19F, Month 10
|
180 Participants
|
191 Participants
|
196 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - Booster Vaccination
Anti-23F, Month 10
|
179 Participants
|
190 Participants
|
194 Participants
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=190 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=198 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=202 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-1, Month 9
|
0.2 μg/mL
Interval 0.17 to 0.22
|
0.22 μg/mL
Interval 0.19 to 0.26
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-4, Month 9
|
0.39 μg/mL
Interval 0.34 to 0.46
|
0.43 μg/mL
Interval 0.37 to 0.5
|
0.38 μg/mL
Interval 0.34 to 0.43
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-5, Month 9
|
0.41 μg/mL
Interval 0.36 to 0.47
|
0.42 μg/mL
Interval 0.37 to 0.48
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-6B, Month 9
|
0.3 μg/mL
Interval 0.25 to 0.36
|
0.32 μg/mL
Interval 0.27 to 0.38
|
0.13 μg/mL
Interval 0.11 to 0.16
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-7F, Month 9
|
0.6 μg/mL
Interval 0.54 to 0.68
|
0.62 μg/mL
Interval 0.55 to 0.71
|
0.03 μg/mL
Interval 0.03 to 0.03
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-9V, Month 9
|
0.68 μg/mL
Interval 0.6 to 0.78
|
0.76 μg/mL
Interval 0.66 to 0.89
|
0.55 μg/mL
Interval 0.49 to 0.62
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-14, Month 9
|
1.06 μg/mL
Interval 0.9 to 1.26
|
1.14 μg/mL
Interval 0.95 to 1.36
|
1.55 μg/mL
Interval 1.35 to 1.79
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-18C, Month 9
|
0.58 μg/mL
Interval 0.49 to 0.68
|
0.43 μg/mL
Interval 0.36 to 0.5
|
0.4 μg/mL
Interval 0.35 to 0.45
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-19F, Month 9
|
0.79 μg/mL
Interval 0.64 to 0.99
|
0.9 μg/mL
Interval 0.73 to 1.11
|
0.31 μg/mL
Interval 0.25 to 0.37
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-23F, Month 9
|
0.33 μg/mL
Interval 0.27 to 0.39
|
0.38 μg/mL
Interval 0.32 to 0.46
|
0.26 μg/mL
Interval 0.22 to 0.3
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-1, Month 10
|
2.16 μg/mL
Interval 1.89 to 2.46
|
2.5 μg/mL
Interval 2.19 to 2.89
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-4, Month 10
|
3.04 μg/mL
Interval 2.7 to 3.42
|
3.29 μg/mL
Interval 2.89 to 3.73
|
4.01 μg/mL
Interval 3.53 to 4.56
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-5, Month 10
|
3.27 μg/mL
Interval 2.9 to 3.7
|
3.27 μg/mL
Interval 2.9 to 3.68
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-6B, Month 10
|
1.45 μg/mL
Interval 1.23 to 1.71
|
1.41 μg/mL
Interval 1.19 to 1.67
|
2.52 μg/mL
Interval 2.15 to 2.96
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-7F, Month 10
|
3.79 μg/mL
Interval 3.4 to 4.23
|
4.06 μg/mL
Interval 3.63 to 4.54
|
0.03 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-9V, Month 10
|
3.96 μg/mL
Interval 3.58 to 4.39
|
4.23 μg/mL
Interval 3.78 to 4.74
|
6.05 μg/mL
Interval 5.38 to 6.8
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-14, Month 10
|
4.59 μg/mL
Interval 4.06 to 5.19
|
4.95 μg/mL
Interval 4.38 to 5.6
|
7.31 μg/mL
Interval 6.37 to 8.39
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-18C, Month 10
|
6.36 μg/mL
Interval 5.56 to 7.27
|
4.63 μg/mL
Interval 4.09 to 5.25
|
5.08 μg/mL
Interval 4.47 to 5.78
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-19F, Month 10
|
5.45 μg/mL
Interval 4.72 to 6.3
|
5.8 μg/mL
Interval 5.04 to 6.68
|
2.4 μg/mL
Interval 2.14 to 2.7
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - Booster Vaccination
Anti-23F, Month 10
|
2.32 μg/mL
Interval 1.98 to 2.71
|
2.6 μg/mL
Interval 2.24 to 3.02
|
5.32 μg/mL
Interval 4.49 to 6.31
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=156 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=154 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=168 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-6B, Month 10
|
681.4 Titers
Interval 514.6 to 902.1
|
763.3 Titers
Interval 581.9 to 1001.3
|
1807.5 Titers
Interval 1408.0 to 2320.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-1, Month 9
|
5.5 Titers
Interval 4.7 to 6.4
|
5.6 Titers
Interval 4.7 to 6.7
|
5 Titers
Interval 4.4 to 5.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-4, Month 9
|
11.3 Titers
Interval 8.6 to 14.9
|
15.3 Titers
Interval 11.3 to 20.6
|
12.3 Titers
Interval 9.3 to 16.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-5, Month 9
|
7.2 Titers
Interval 6.1 to 8.5
|
7 Titers
Interval 6.0 to 8.1
|
4.3 Titers
Interval 4.0 to 4.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-6B, Month 9
|
52 Titers
Interval 34.8 to 77.7
|
96.7 Titers
Interval 63.1 to 148.0
|
27.4 Titers
Interval 18.6 to 40.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-7F, Month 9
|
818.9 Titers
Interval 642.2 to 1044.3
|
754.3 Titers
Interval 598.4 to 950.8
|
138.1 Titers
Interval 91.2 to 209.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-9V, Month 9
|
267.2 Titers
Interval 212.7 to 335.8
|
338.7 Titers
Interval 264.8 to 433.2
|
149.5 Titers
Interval 112.4 to 198.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-14, Month 9
|
117.3 Titers
Interval 82.9 to 165.9
|
142.5 Titers
Interval 101.3 to 200.4
|
156 Titers
Interval 114.5 to 212.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-18C, Month 9
|
8.2 Titers
Interval 6.2 to 10.8
|
6.8 Titers
Interval 5.3 to 8.5
|
7 Titers
Interval 5.7 to 8.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-19F, Month 9
|
13.8 Titers
Interval 10.6 to 18.1
|
15.4 Titers
Interval 11.8 to 20.2
|
7.8 Titers
Interval 6.2 to 9.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-23F, Month 9
|
314.1 Titers
Interval 198.6 to 496.7
|
350.4 Titers
Interval 229.8 to 534.2
|
338.9 Titers
Interval 219.9 to 522.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-1, Month 10
|
208.8 Titers
Interval 106.6 to 271.7
|
221.4 Titers
Interval 165.1 to 297.0
|
4.6 Titers
Interval 4.2 to 5.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-4, Month 10
|
1046.8 Titers
Interval 865.8 to 1265.7
|
1121.6 Titers
Interval 909.4 to 1383.3
|
2335.8 Titers
Interval 1946.3 to 2803.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-5, Month 10
|
149.3 Titers
Interval 119.2 to 187.0
|
132.4 Titers
Interval 103.8 to 168.9
|
4.1 Titers
Interval 4.0 to 4.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-7F, Month 10
|
3936.5 Titers
Interval 3413.2 to 4540.0
|
3976 Titers
Interval 3390.2 to 4663.1
|
129.1 Titers
Interval 85.9 to 193.9
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-9V, Month 10
|
2512.9 Titers
Interval 2213.1 to 2853.2
|
2257.6 Titers
Interval 1974.3 to 2581.5
|
3889.5 Titers
Interval 3260.1 to 4640.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-14, Month 10
|
1534.2 Titers
Interval 1290.9 to 1823.3
|
1896.3 Titers
Interval 1591.3 to 2259.7
|
1867.9 Titers
Interval 1540.5 to 2265.1
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-18C, Month 10
|
720.7 Titers
Interval 597.5 to 869.4
|
385.9 Titers
Interval 303.5 to 490.8
|
660.4 Titers
Interval 520.9 to 837.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-19F, Month 10
|
435.7 Titers
Interval 336.3 to 564.5
|
475.4 Titers
Interval 377.8 to 598.1
|
123.2 Titers
Interval 95.9 to 158.2
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - Booster Vaccination
Opsono-23F, Month 10
|
2895.4 Titers
Interval 2276.1 to 3683.1
|
2895.3 Titers
Interval 2419.3 to 3465.0
|
12418.7 Titers
Interval 10171.8 to 15161.9
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after the administration of the booster dose(Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=187 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=196 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=201 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.
Anti-6A, Month 9
|
50 Participants
|
56 Participants
|
28 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.
Anti-19A, Month 9
|
61 Participants
|
63 Participants
|
29 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.
Anti-6A, Month 10
|
135 Participants
|
142 Participants
|
160 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - Booster Vaccination.
Anti-19A, Month 10
|
130 Participants
|
139 Participants
|
97 Participants
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after the administration of the booster dose (Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=187 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=196 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=201 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination
Anti-6A, Month 9
|
0.1 μg/mL
Interval 0.09 to 0.12
|
0.11 μg/mL
Interval 0.09 to 0.13
|
0.06 μg/mL
Interval 0.05 to 0.07
|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination
Anti-19A, Month 9
|
0.12 μg/mL
Interval 0.1 to 0.15
|
0.12 μg/mL
Interval 0.09 to 0.13
|
0.06 μg/mL
Interval 0.05 to 0.07
|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination
Anti-6A, Month 10
|
0.45 μg/mL
Interval 0.36 to 0.55
|
0.49 μg/mL
Interval 0.4 to 0.61
|
0.71 μg/mL
Interval 0.58 to 0.88
|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - Booster Vaccination
Anti-19A, Month 10
|
0.5 μg/mL
Interval 0.39 to 0.63
|
0.52 μg/mL
Interval 0.41 to 0.66
|
0.21 μg/mL
Interval 0.17 to 0.25
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after the administration of the booster dose (Month 10)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=151 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=148 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=167 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.
Opsono-6A, Month 9
|
23.3 Titers
Interval 15.7 to 34.6
|
30.7 Titers
Interval 20.8 to 45.2
|
15.5 Titers
Interval 11.1 to 21.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.
Opsono-19A, Month 9
|
5.7 Titers
Interval 4.6 to 7.0
|
5.5 Titers
Interval 4.6 to 6.5
|
5.5 Titers
Interval 4.6 to 6.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.
Opsono-6A, Month 10
|
143.3 Titers
Interval 99.1 to 207.3
|
197.1 Titers
Interval 138.0 to 281.3
|
493.3 Titers
Interval 357.1 to 681.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - Booster Vaccination.
Opsono-19A, Month 10
|
34.9 Titers
Interval 24.8 to 49.2
|
24.6 Titers
Interval 17.7 to 34.3
|
7.7 Titers
Interval 6.2 to 9.5
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=189 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=198 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=201 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.
Anti-PD, Month 9
|
421 EL.U/mL
Interval 370.3 to 478.5
|
520.5 EL.U/mL
Interval 455.8 to 594.3
|
80.8 EL.U/mL
Interval 73.1 to 89.4
|
|
Concentrations of Antibodies Against Protein D (Anti-PD) - Booster Vaccination.
Anti-PD, Month 10
|
1715 EL.U/mL
Interval 1510.3 to 1947.5
|
1936.8 EL.U/mL
Interval 1710.5 to 2193.2
|
84.1 EL.U/mL
Interval 76.0 to 93.1
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-D and anti-T antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in international units per milliliter (IU/mL). The seropositivity cut-off value was greater than or equal to (≥) 0.1 IU/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=186 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=194 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=197 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.
Anti-diphteria, Month 9
|
0.235 IU/mL
Interval 0.205 to 0.27
|
0.232 IU/mL
Interval 0.203 to 0.264
|
0.266 IU/mL
Interval 0.235 to 0.301
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.
Anti-tetanus, Month 9
|
0.728 IU/mL
Interval 0.656 to 0.809
|
0.536 IU/mL
Interval 0.477 to 0.603
|
0.232 IU/mL
Interval 0.202 to 0.267
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.
Anti-diphteria, Month 10
|
4.061 IU/mL
Interval 3.601 to 4.58
|
3.226 IU/mL
Interval 2.866 to 3.632
|
4.882 IU/mL
Interval 4.425 to 5.386
|
|
Concentrations of Antibodies Against Diphtheria and Tetanus Toxoids (Anti-D and T) - Booster Vaccination.
Anti-tetanus, Month 10
|
8.628 IU/mL
Interval 7.867 to 9.462
|
5.989 IU/mL
Interval 5.461 to 6.568
|
3.248 IU/mL
Interval 2.859 to 3.69
|
SECONDARY outcome
Timeframe: Prior to (Month 9) and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-PRP antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (µg/mL). The seropositivity cut-off value was ≥ 0.15 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=184 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=192 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=197 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination
Anti-PRP, Month 9
|
0.475 µg/mL
Interval 0.386 to 0.585
|
0.855 µg/mL
Interval 0.682 to 1.072
|
0.371 µg/mL
Interval 0.298 to 0.461
|
|
Anti-polyribosyl-ribitol Phosphate (Anti-PRP) Antibody Concentrations - Booster Vaccination
Anti-PRP, Month 10
|
19.331 µg/mL
Interval 16.144 to 23.147
|
39.383 µg/mL
Interval 32.617 to 47.551
|
23.676 µg/mL
Interval 18.944 to 29.591
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-PT, anti-FHA and anti-PRN antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value was ≥ 5 EL.U/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=186 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=194 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=197 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-FHA, Month 9
|
34 EL.U/mL
Interval 29.4 to 39.4
|
35.3 EL.U/mL
Interval 30.8 to 40.6
|
34.7 EL.U/mL
Interval 30.1 to 39.9
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-PT, Month 9
|
7.4 EL.U/mL
Interval 6.6 to 8.4
|
6 EL.U/mL
Interval 5.4 to 6.7
|
6.6 EL.U/mL
Interval 5.9 to 7.3
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-PRN, Month 9
|
14.1 EL.U/mL
Interval 12.3 to 16.2
|
6.8 EL.U/mL
Interval 5.9 to 7.9
|
8.6 EL.U/mL
Interval 7.4 to 10.0
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-PT, Month 10
|
53.5 EL.U/mL
Interval 48.3 to 59.2
|
47.4 EL.U/mL
Interval 42.9 to 52.5
|
54.8 EL.U/mL
Interval 48.9 to 61.4
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-FHA, Month 10
|
343.5 EL.U/mL
Interval 308.0 to 383.1
|
135.7 EL.U/mL
Interval 121.2 to 151.9
|
140 EL.U/mL
Interval 123.2 to 159.1
|
|
Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN) Antibody Concentrations - Booster Vaccination.
Anti-PRN, Month 10
|
281.7 EL.U/mL
Interval 247.2 to 321.0
|
97.8 EL.U/mL
Interval 85.4 to 112.0
|
106.4 EL.U/mL
Interval 91.5 to 123.8
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). A seroprotected subject was a subject whose antibody ChemiLuminescence ImmunoAssay (CLIA) concentration was greater than or equal to the cut-off value ≥ 10 milli-international units per milliliter (mIU/mL). Note: investigations on the quality of some serology assays revealed that the anti-HBs ELISA overestimated concentration between 10-100 mIU/mL while values \> 100 mIU/mL were confirmed valid. Therefore, all available samples at one month post-dose III and one month post-dose IV timepoints for which the anti-HBs antibody concentration was between 10-100 mIU/mL by in-house ELISA, were retested by the commercial assay Centaur™, an FDA-approved and CE-marked CLIA with a cut-off defining seropositivity of 6.2 mIU/mL. Anti-HBs seroprotection was redefined as in-house ELISA concentration \> 100 mIU/mL or CLIA concentration \> 10 mIU/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=125 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=124 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=135 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.
Anti-HBs, Month 9
|
142.1 mIU/mL
Interval 113.4 to 178.1
|
9.9 mIU/mL
Interval 8.8 to 11.2
|
9.9 mIU/mL
Interval 8.8 to 11.2
|
|
Anti-hepatitis B Surface Antigen (Anti-HBs) Antibody Concentrations - Booster Vaccination.
Anti-HBs, Month 10
|
1981 mIU/mL
Interval 1552.0 to 2528.7
|
8.6 mIU/mL
Interval 7.6 to 9.9
|
8.5 mIU/mL
Interval 7.6 to 9.5
|
SECONDARY outcome
Timeframe: Prior (Month 9) to and one month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-polio 1, -polio 2, -polio 3 antibody titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value ≥ 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=167 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=173 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=182 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 1, Month 9
|
8.3 Titers
Interval 7.0 to 10.0
|
7.3 Titers
Interval 6.3 to 8.4
|
7 Titers
Interval 6.1 to 8.0
|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 2, Month 9
|
13.4 Titers
Interval 10.8 to 16.6
|
10.6 Titers
Interval 8.8 to 12.7
|
10.4 Titers
Interval 8.9 to 12.2
|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 3, Month 9
|
11.3 Titers
Interval 9.3 to 13.9
|
9 Titers
Interval 7.5 to 10.7
|
8.7 Titers
Interval 7.4 to 10.3
|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 1, Month 10
|
370.7 Titers
Interval 289.8 to 474.2
|
177.5 Titers
Interval 135.8 to 231.9
|
221.2 Titers
Interval 171.5 to 285.3
|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 2, Month 10
|
710.8 Titers
Interval 588.0 to 859.0
|
338.8 Titers
Interval 272.7 to 420.8
|
481.4 Titers
Interval 391.0 to 592.7
|
|
Anti-polio Types 1, 2 and 3 Titers - Booster Vaccination.
Anti-polio 3, Month 10
|
631.5 Titers
Interval 495.7 to 804.4
|
311.9 Titers
Interval 240.4 to 404.6
|
348.3 Titers
Interval 263.6 to 460.2
|
SECONDARY outcome
Timeframe: One month after (Month 10) the administration of the booster dosePopulation: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
A booster responder to PT/FHA/PRN was defined as a subject with antibodies concentration ≥ 5 EL.U/mL against PT/FHA/PRN in subjects who were initially seronegative for anti-PT/FHA/PRN antibodies (i.e., subjects with anti-PT/FHA/PRN antibody concentrations \< 5 EL.U/mL), or antibody concentration ≥ 2 fold the pre-vaccination antibody concentration in subjects who were initially seropositive (i.e., subjects with anti-PT/FHA/PRN antibody concentrations ≥ 5 EL.U/mL).
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=140 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=145 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=155 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-PT, S- seronegative
|
40 Participants
|
47 Participants
|
48 Participants
|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-PT, S+ seropositive
|
95 Participants
|
94 Participants
|
98 Participants
|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-FHA, S- seronegative
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-FHA, S+ seropositive
|
128 Participants
|
119 Participants
|
125 Participants
|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-PRN, S- seronegative
|
18 Participants
|
56 Participants
|
51 Participants
|
|
Number of Subjects With Booster Vaccine Response Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antibodies - Booster Vaccination.
Anti-PRN, S+ seropositive
|
122 Participants
|
88 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Antibody concentrations against the pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=166 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=169 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=177 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-1, Month 21
|
106 Participants
|
108 Participants
|
6 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-4, Month 21
|
101 Participants
|
102 Participants
|
130 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-5, Month 21
|
129 Participants
|
129 Participants
|
10 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-6B, Month 21
|
94 Participants
|
96 Participants
|
133 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-7F, Month 21
|
157 Participants
|
157 Participants
|
15 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-9V, Month 21
|
155 Participants
|
157 Participants
|
160 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-14, Month 21
|
149 Participants
|
156 Participants
|
173 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-18C, Month 21
|
160 Participants
|
155 Participants
|
161 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-19F, Month 21
|
158 Participants
|
158 Participants
|
134 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-23F, Month 21
|
123 Participants
|
126 Participants
|
153 Participants
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-pneumococcal serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=166 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=169 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=177 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-1, Month 21
|
0.3 μg/mL
Interval 0.26 to 0.35
|
0.32 μg/mL
Interval 0.28 to 0.38
|
0.04 μg/mL
Interval 0.03 to 0.04
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-4, Month 21
|
0.25 μg/mL
Interval 0.22 to 0.29
|
0.29 μg/mL
Interval 0.25 to 0.34
|
0.36 μg/mL
Interval 0.32 to 0.42
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-5, Month 21
|
0.45 μg/mL
Interval 0.39 to 0.53
|
0.47 μg/mL
Interval 0.39 to 0.55
|
0.05 μg/mL
Interval 0.04 to 0.05
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-6B, Month 21
|
0.3 μg/mL
Interval 0.25 to 0.36
|
0.32 μg/mL
Interval 0.26 to 0.4
|
0.46 μg/mL
Interval 0.38 to 0.56
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-7F, Month 21
|
0.72 μg/mL
Interval 0.63 to 0.81
|
0.73 μg/mL
Interval 0.64 to 0.84
|
0.04 μg/mL
Interval 0.03 to 0.05
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-9V, Month 21
|
0.74 μg/mL
Interval 0.63 to 0.88
|
0.78 μg/mL
Interval 0.66 to 0.91
|
0.81 μg/mL
Interval 0.7 to 0.94
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-14, Month 21
|
0.73 μg/mL
Interval 0.62 to 0.86
|
0.85 μg/mL
Interval 0.73 to 0.99
|
1.28 μg/mL
Interval 1.1 to 1.48
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-18C, Month 21
|
1.03 μg/mL
Interval 0.89 to 1.19
|
0.64 μg/mL
Interval 0.56 to 0.74
|
1.66 μg/mL
Interval 1.59 to 1.75
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-19F, Month 21
|
1.48 μg/mL
Interval 1.22 to 1.8
|
1.46 μg/mL
Interval 1.2 to 1.78
|
1.76 μg/mL
Interval 1.59 to 1.98
|
|
Antibody Concentrations Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F (Anti-1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) - 12 Months After Booster Dose.
Anti-23F, Month 21
|
0.51 μg/mL
Interval 0.41 to 0.63
|
0.52 μg/mL
Interval 0.42 to 1.63
|
1.01 μg/mL
Interval 0.83 to 1.24
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=159 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=152 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=165 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-1, Month 21
|
10.9 Titers
Interval 8.5 to 14.1
|
9.9 Titers
Interval 7.8 to 12.5
|
4.3 Titers
Interval 3.9 to 4.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-4, Month 21
|
12 Titers
Interval 9.1 to 15.9
|
15.5 Titers
Interval 11.0 to 21.7
|
45.2 Titers
Interval 30.8 to 66.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-5, Month 21
|
12.9 Titers
Interval 10.4 to 16.0
|
13.7 Titers
Interval 11.0 to 17.1
|
4.1 Titers
Interval 3.9 to 4.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-6B, Month 21
|
77.7 Titers
Interval 48.8 to 123.8
|
137.6 Titers
Interval 83.5 to 226.6
|
220 Titers
Interval 145.4 to 332.8
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-7F, Month 21
|
1982.9 Titers
Interval 1568.8 to 2506.2
|
2205.6 Titers
Interval 1833.4 to 2653.4
|
738.1 Titers
Interval 549.8 to 990.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-9V, Month 21
|
465.9 Titers
Interval 324.2 to 669.5
|
470 Titers
Interval 325.8 to 677.9
|
476.2 Titers
Interval 317.8 to 713.5
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-14, Month 21
|
93.1 Titers
Interval 60.0 to 144.4
|
151.6 Titers
Interval 97.7 to 235.4
|
238.7 Titers
Interval 163.5 to 348.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-18C, Month 21
|
21.6 Titers
Interval 15.2 to 30.6
|
12.5 Titers
Interval 8.9 to 17.6
|
15.3 Titers
Interval 10.9 to 21.3
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-19F, Month 21
|
31.1 Titers
Interval 22.6 to 42.8
|
32.9 Titers
Interval 23.8 to 45.4
|
15.1 Titers
Interval 11.0 to 20.6
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F - 12 Months After Booster Dose.
Opsono-23F, Month 21
|
366.5 Titers
Interval 218.3 to 615.3
|
706.1 Titers
Interval 443.5 to 1124.3
|
3879.8 Titers
Interval 2774.4 to 5425.5
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Antibody concentrations against the cross-reactive pneumococcal serotypes were assessed by 22F-inhibition ELISA. The reference cut-off value of the assay was an antibody concentration greater than or equal to (≥) 0.02 µg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=165 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=166 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=176 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-6A, Month 21
|
54 Participants
|
57 Participants
|
92 Participants
|
|
Number of Subjects With Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) ≥ 0.2 μg/mL - 12 Months After Booster Dose.
Anti-19A, Month 21
|
120 Participants
|
97 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-pneumococcal cross-reactive serotype 6A and 19A antibody concentrations were assessed by 22F-inhibition ELISA, presented as geometric mean concentrations (GMCs) and expressed in micrograms per milliliter (μg/mL). The seropositivity cut-off value was ≥ 0.05 μg/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=165 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=166 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=176 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.
Anti-6A, Month 21
|
0.14 μg/mL
Interval 0.12 to 0.17
|
0.15 μg/mL
Interval 0.12 to 0.19
|
0.22 μg/mL
Interval 0.18 to 0.27
|
|
Antibody Concentrations Against Pneumococcal Cross-reactive Serotypes 6A and 19A (Anti-6A and 19A) - 12 Months After Booster Dose.
Anti-19A, Month 21
|
0.43 μg/mL
Interval 0.35 to 0.53
|
0.29 μg/mL
Interval 0.23 to 0.36
|
0.21 μg/mL
Interval 0.16 to 0.27
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Titers were presented as geometric mean titers (GMTs), for the seropositivity cut-off value of 8.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=150 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=146 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=158 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.
Opsono-6A, Month 21
|
21.6 Titers
Interval 14.1 to 33.1
|
24.8 Titers
Interval 15.5 to 39.5
|
56.5 Titers
Interval 36.4 to 87.7
|
|
Opsonophagocytic Activity (OPA) Titers Against Pneumococcal Cross-reactive Serotypes 6A and 19A - 12 Months After Booster Dose.
Opsono-19A, Month 21
|
12.6 Titers
Interval 9.5 to 16.7
|
9.1 Titers
Interval 7.0 to 11.9
|
9.6 Titers
Interval 7.1 to 12.9
|
SECONDARY outcome
Timeframe: At Month 21, 12 months after the administration of the booster dose (at 23-25 months of age)Population: The Booster ATP cohort for immunogenicity included all evaluable subjects, for whom assay results were available for antibodies against at least one study vaccine antigen component after booster vaccination.
Anti-PD antibody concentrations were presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the assay was ≥ 100 EL.U/mL.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=168 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=170 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=178 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Concentrations of Antibodies Against Protein D (Anti-PD) - 12 Months After Booster Dose.
|
332 EL.U/mL
Interval 287.1 to 384.0
|
423 EL.U/mL
Interval 359.9 to 497.1
|
81.4 EL.U/mL
Interval 73.1 to 90.6
|
SECONDARY outcome
Timeframe: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Positive cultures of H. influenzae\* (HI) and S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), M9 (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=259 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=259 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any SP, Month 3
|
102 Participants
|
109 Participants
|
100 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any SP, Month 9
|
115 Participants
|
134 Participants
|
119 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any SP, Month 12
|
121 Participants
|
131 Participants
|
126 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any SP, Month 16
|
151 Participants
|
135 Participants
|
148 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any SP, Month 21
|
154 Participants
|
139 Participants
|
131 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any HI, Month 3
|
94 Participants
|
91 Participants
|
85 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any HI, Month 9
|
152 Participants
|
155 Participants
|
144 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any HI, Month 12
|
159 Participants
|
160 Participants
|
165 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any HI, Month 16
|
185 Participants
|
169 Participants
|
162 Participants
|
|
Number of Subjects With Positive Cultures of Haemophilus Influenzae and/or Streptococcus Pneumoniae in the Nasopharynx - Primary Vaccination.
Any HI, Month 21
|
192 Participants
|
192 Participants
|
177 Participants
|
SECONDARY outcome
Timeframe: One month after the third dose (Month 3), prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Positive cultures of S. pneumoniae (SP) identified in the nasopharynx at each swab time point: one month post-Dose III (M3), pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=259 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=259 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, VS - M3
|
18 Participants
|
25 Participants
|
21 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, VS - M9
|
16 Participants
|
20 Participants
|
18 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, VS - M12
|
11 Participants
|
18 Participants
|
13 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, VS - M16
|
15 Participants
|
12 Participants
|
12 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, VS - M21
|
8 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, CRS - M3
|
25 Participants
|
32 Participants
|
20 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, CRS - M9
|
15 Participants
|
30 Participants
|
25 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, CRS - M12
|
25 Participants
|
26 Participants
|
27 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, CRS - M16
|
33 Participants
|
33 Participants
|
31 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, CRS - M21
|
28 Participants
|
13 Participants
|
25 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, OS - M3
|
45 Participants
|
40 Participants
|
51 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, OS - M9
|
69 Participants
|
61 Participants
|
60 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, OS - M12
|
74 Participants
|
69 Participants
|
70 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, OS - M16
|
86 Participants
|
67 Participants
|
89 Participants
|
|
Number of Subjects With Positive Cultures of Streptococcus Pneumoniae Vaccine Seroptypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) in the Nasopharynx - Primary Vaccination.
S. pneumoniae, OS - M21
|
97 Participants
|
81 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Acquisition of new H. influenzae\* (HI) and S. pneumoniae (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age). \*Data presented only include results from samples confirmed as positive for H. influenzae / Non-typeable H. influenzae after differentiation from H. haemolyticus by Polymerase Chain Reaction (PCR) assay.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=256 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=259 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=258 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any SP, M9
|
103 Participants
|
114 Participants
|
107 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any SP, M12
|
86 Participants
|
95 Participants
|
90 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any SP, M16
|
128 Participants
|
105 Participants
|
125 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any SP, M21
|
132 Participants
|
113 Participants
|
110 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any HI, M9
|
88 Participants
|
84 Participants
|
83 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any HI, M12
|
47 Participants
|
48 Participants
|
58 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any HI, M16
|
71 Participants
|
55 Participants
|
64 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae and Haemophilus Influenzae Strains Identified in Nasopharyngeal Swabs - Primary Vaccination.
Any HI, M21
|
73 Participants
|
75 Participants
|
71 Participants
|
SECONDARY outcome
Timeframe: Prior to the booster dose (Month 9), 3 months after the booster dose (Month 12), 7 months after the booster dose (Month 16) and 12 months after the booster dose (Month 21)Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Acquisition of new S. pneumonia (SP) strains, identified in the nasopharynx at each swab time point: pre-booster vaccination (11-13 months of age), M12 (14-16 months of age), M16 (18-20 months of age) and M21 (23-25 months of age).
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=256 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=259 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=258 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, VS - M9
|
14 Participants
|
11 Participants
|
15 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, VS - M12
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, VS - M16
|
13 Participants
|
7 Participants
|
9 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, VS - M21
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, CRS - M9
|
13 Participants
|
26 Participants
|
20 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, CRS - M12
|
19 Participants
|
15 Participants
|
20 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, CRS - M16
|
27 Participants
|
25 Participants
|
24 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, CRS - M21
|
22 Participants
|
8 Participants
|
18 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, OS - M9
|
64 Participants
|
55 Participants
|
57 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, OS - M12
|
52 Participants
|
59 Participants
|
52 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, OS - M16
|
74 Participants
|
55 Participants
|
77 Participants
|
|
Number of Subjects With Acquisition of New Streptococcus Pneumoniae Vaccine Serotypes (VS), Cross-reactive Serotypes (CRS) or Other Serotypes (OS) Identified in Nasopharyngeal Swabs - Primary Vaccination.
S. pneumoniae, OS - M21
|
87 Participants
|
69 Participants
|
69 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across dosesPopulation: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling spreading beyond (\>) 30 millimeters from injection site.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Pain, Dose 3
|
9 Participants
|
4 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Redness, Dose 3
|
141 Participants
|
119 Participants
|
121 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Redness, Dose 3
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Swelling, Dose 3
|
142 Participants
|
133 Participants
|
118 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Swelling, Dose 3
|
4 Participants
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Pain, Across doses
|
205 Participants
|
193 Participants
|
178 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Pain, Across doses
|
42 Participants
|
40 Participants
|
29 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Redness, Across doses
|
197 Participants
|
193 Participants
|
184 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Redness, Across doses
|
12 Participants
|
26 Participants
|
19 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Pain, Dose 2
|
130 Participants
|
120 Participants
|
104 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Pain, Dose 2
|
11 Participants
|
12 Participants
|
13 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Redness, Dose 2
|
125 Participants
|
131 Participants
|
121 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Redness, Dose 2
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Swelling, Dose 2
|
143 Participants
|
135 Participants
|
125 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Swelling, Dose 2
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Pain, Dose 3
|
100 Participants
|
87 Participants
|
73 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Pain, Dose 1
|
168 Participants
|
159 Participants
|
142 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Pain, Dose 1
|
30 Participants
|
31 Participants
|
22 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Redness, Dose 1
|
105 Participants
|
134 Participants
|
120 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Redness, Dose 1
|
7 Participants
|
21 Participants
|
15 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Swelling, Dose 1
|
140 Participants
|
145 Participants
|
113 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Swelling, Dose 1
|
12 Participants
|
18 Participants
|
15 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Any Swelling, Across doses
|
205 Participants
|
199 Participants
|
179 Participants
|
|
Number of Subjects With Solicited Local Symptoms - Primary Vaccination
Grade 3 Swelling, Across doses
|
18 Participants
|
29 Participants
|
24 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following each dose and across dosesPopulation: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Drowsiness, Dose 1
|
183 Participants
|
171 Participants
|
164 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Drowsiness, Dose 1
|
4 Participants
|
7 Participants
|
6 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Drowsiness, Dose 1
|
178 Participants
|
171 Participants
|
160 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Temperature, Dose 1
|
88 Participants
|
63 Participants
|
40 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Temperature, Dose 1
|
88 Participants
|
62 Participants
|
40 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Irritability, Dose 1
|
190 Participants
|
185 Participants
|
180 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Irritability, Dose 1
|
18 Participants
|
18 Participants
|
8 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Irritability, Dose 1
|
186 Participants
|
182 Participants
|
173 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Loss of appetite, Dose 1
|
88 Participants
|
94 Participants
|
87 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Loss of appetite, Dose 1
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Loss of appetite, Dose 1
|
85 Participants
|
94 Participants
|
84 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Drowsiness, Dose 2
|
157 Participants
|
141 Participants
|
143 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Drowsiness, Dose 2
|
5 Participants
|
5 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Drowsiness, Dose 2
|
152 Participants
|
141 Participants
|
141 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Temperature, Dose 2
|
82 Participants
|
60 Participants
|
60 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Temperature, Dose 2
|
81 Participants
|
58 Participants
|
59 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Irritability, Dose 2
|
181 Participants
|
176 Participants
|
165 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Irritability, Dose 2
|
14 Participants
|
12 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Irritability, Dose 2
|
177 Participants
|
172 Participants
|
154 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Loss of appetite, Dose 2
|
82 Participants
|
73 Participants
|
85 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Loss of appetite, Dose 2
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Loss of appetite, Dose 2
|
80 Participants
|
69 Participants
|
81 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Drowsiness, Dose 3
|
127 Participants
|
114 Participants
|
118 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Drowsiness, Dose 3
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Drowsiness, Dose 3
|
124 Participants
|
111 Participants
|
115 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Temperature, Dose 3
|
70 Participants
|
50 Participants
|
38 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Temperature, Dose 3
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Temperature, Dose 3
|
67 Participants
|
47 Participants
|
34 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Irritability, Dose 3
|
138 Participants
|
137 Participants
|
138 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Irritability, Dose 3
|
19 Participants
|
15 Participants
|
5 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Irritability, Dose 3
|
132 Participants
|
133 Participants
|
133 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Loss of appetite, Dose 3
|
63 Participants
|
59 Participants
|
59 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Loss of appetite, Dose 3
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Loss of appetite, Dose 3
|
58 Participants
|
55 Participants
|
54 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Drowsiness, Across doses
|
231 Participants
|
220 Participants
|
215 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Drowsiness, Across doses
|
14 Participants
|
13 Participants
|
7 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Drowsiness, Across doses
|
227 Participants
|
219 Participants
|
213 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Temperature, Across doses
|
153 Participants
|
124 Participants
|
110 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Temperature, Across doses
|
149 Participants
|
120 Participants
|
106 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Irritability, Across doses
|
241 Participants
|
230 Participants
|
235 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Irritability, Across doses
|
42 Participants
|
37 Participants
|
16 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Irritability, Across doses
|
238 Participants
|
227 Participants
|
232 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Any Loss of appetite, Across doses
|
155 Participants
|
145 Participants
|
153 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Grade 3 Loss of appetite, Across doses
|
4 Participants
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Primary Vaccination
Related Loss of appetite, Across doses
|
152 Participants
|
144 Participants
|
148 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) post-primary vaccinationPopulation: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
An AE is 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. "Any" is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs) - Primary Vaccination.
|
181 Participants
|
177 Participants
|
185 Participants
|
SECONDARY outcome
Timeframe: Throughout the entire study period (up to Month 21)Population: The Primary Total Vaccinated cohort included all vaccinated subjects who received at least one primary dose.
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs)
|
35 Participants
|
26 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following booster dosePopulation: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any occurrence of the specified symptom regardless of intensity. Grade 3 pain was defined as cried when limb was moved/spontaneously painful. Grade 3 redness/swelling was defined as redness/swelling \> 30 millimeters from injection site.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=257 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=258 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=258 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Any Pain
|
174 Participants
|
161 Participants
|
145 Participants
|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Grade 3 Pain
|
21 Participants
|
21 Participants
|
7 Participants
|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Any Redness
|
175 Participants
|
144 Participants
|
180 Participants
|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Grade 3 Redness
|
22 Participants
|
10 Participants
|
10 Participants
|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Any Swelling
|
185 Participants
|
146 Participants
|
160 Participants
|
|
Number of Subjects With Solicited Local Symptoms -Booster Vaccination
Grade 3 Swelling
|
27 Participants
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: During the 4-day (Days 0-3) post-vaccination period following booster dosePopulation: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
Solicited general symptoms assessed include drowsiness, fever (defined as rectal temperature ≥ 38.0°C), irritability, and loss of appetite. Any was defined as incidence of the specified symptom regardless of intensity. Grade 3 drowsiness was defined as drowsiness which prevented normal everyday activities. Grade 3 fever was defined as fever (rectal temperature) above (\>) 40.0 degree Celsius (°C). Grade 3 irritability was defined as crying that could not be comforted/preventing normal activity. Grade 3 loss of appetite was defined as the subject not eating at all. Related symptom was defined as a general symptom assessed by the investigator as causally related to study vaccination.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=256 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=258 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=258 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Any Drowsiness
|
131 Participants
|
118 Participants
|
128 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Grade 3 Drowsiness
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Related Drowsiness
|
126 Participants
|
110 Participants
|
121 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Any Temperature
|
100 Participants
|
100 Participants
|
103 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Grade 3 Temperature
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Related Temperature
|
95 Participants
|
89 Participants
|
93 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Any Irritability
|
167 Participants
|
161 Participants
|
166 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Grade 3 Irritability
|
11 Participants
|
8 Participants
|
1 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Related Irritability
|
161 Participants
|
147 Participants
|
159 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Any Loss of appetite
|
93 Participants
|
83 Participants
|
111 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Grade 3 Loss of appetite
|
5 Participants
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Solicited General Symptoms - Booster Vaccination.
Related Loss of appetite
|
89 Participants
|
72 Participants
|
101 Participants
|
SECONDARY outcome
Timeframe: Within the 31-day (Days 0-30) after booster vaccinationPopulation: The Booster Total Vaccinated cohort included all subjects vaccinated with the booster dose.
An AE is 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. "Any" was defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination.
Outcome measures
| Measure |
Synflorix + Infanrix Hexa Group
n=257 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=259 Participants
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=258 Participants
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Number of Subjects With Unsolicited Adverse Events (AEs) - Booster Vaccination.
|
106 Participants
|
105 Participants
|
105 Participants
|
Adverse Events
Synflorix + Infanrix Hexa Group
Serious events: 35 serious events
Other events: 260 other events
Deaths: 0 deaths
Synflorix + Pediacel Group
Serious events: 26 serious events
Other events: 260 other events
Deaths: 0 deaths
Prevenar + Pediacel Group
Serious events: 35 serious events
Other events: 260 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Synflorix + Infanrix Hexa Group
n=260 participants at risk
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 participants at risk
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 participants at risk
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Congenital, familial and genetic disorders
Velo-cardio-facial syndrome
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Coeliac disease
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Intestinal stenosis
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Adhesion
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Pyrexia
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Bronchiolitis
|
1.2%
3/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Bronchopneumonia
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Cellulitis
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Enterovirus infection
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis
|
3.1%
8/260 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.5%
4/260 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.9%
5/260 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis adenovirus
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Meningitis
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Oral herpes
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Otitis media
|
1.2%
3/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Pneumonia
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.2%
3/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Pneumonia primary atypical
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Pyelonephritis
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.2%
3/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
1.9%
5/260 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.9%
5/260 • Number of events 5 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.5%
4/260 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Injury, poisoning and procedural complications
Concussion
|
1.2%
3/260 • Number of events 3 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Injury, poisoning and procedural complications
Greenstick fracture
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Injury, poisoning and procedural complications
Poisoning
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Metabolism and nutrition disorders
Feeding disorder neonatal
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Nervous system disorders
Convulsion
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Respiratory, thoracic and mediastinal disorders
Apparent life threatening event
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.77%
2/260 • Number of events 2 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
1.5%
4/260 • Number of events 4 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Vascular disorders
Haematoma
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.38%
1/260 • Number of events 1 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
0.00%
0/260 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
Other adverse events
| Measure |
Synflorix + Infanrix Hexa Group
n=260 participants at risk
Subjects received 3 doses of Synflorix vaccine co-administered with Infanrix hexa at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Infanrix hexa) thigh or deltoid.
|
Synflorix + Pediacel Group
n=260 participants at risk
Subjects received 3 doses of Synflorix vaccine co-administered with Pediacel at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Synflorix) or left (Pediacel) thigh or deltoid.
|
Prevenar + Pediacel Group
n=260 participants at risk
Subjects received 3 doses of Prevenar co-administered with Pediacel vaccine at 2, 3 and 4 months of age (Study Months 0, 1, 2) and received a booster dose of each vaccine between 11 and 13 months of age (Study Month 9). All vaccines were administered intramuscularly in the right (Prevenar) or left (Pediacel) thigh or deltoid.
|
|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
45.0%
117/260 • Number of events 153 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
48.1%
125/260 • Number of events 160 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
51.2%
133/260 • Number of events 170 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
70.0%
182/260 • Number of events 326 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
66.9%
174/260 • Number of events 309 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
73.5%
191/260 • Number of events 342 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Diarrhoea
|
8.5%
22/260 • Number of events 25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
8.1%
21/260 • Number of events 24 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
5.8%
15/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
9.6%
25/260 • Number of events 25 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.2%
16/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.9%
18/260 • Number of events 19 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Enteritis
|
6.5%
17/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
3.1%
8/260 • Number of events 9 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
4.6%
12/260 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
88.8%
231/260 • Number of events 546 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
80.8%
210/260 • Number of events 528 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
85.4%
222/260 • Number of events 542 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Gastroenteritis
|
8.8%
23/260 • Number of events 24 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.5%
17/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.5%
17/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Injection site haematoma
|
4.6%
12/260 • Number of events 15 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.2%
16/260 • Number of events 16 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
2.7%
7/260 • Number of events 8 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Psychiatric disorders
Irritability
|
96.9%
252/260 • Number of events 676 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
93.1%
242/260 • Number of events 659 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
95.0%
247/260 • Number of events 649 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Otitis media
|
8.5%
22/260 • Number of events 22 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
5.4%
14/260 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
3.8%
10/260 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Pain
|
87.3%
227/260 • Number of events 573 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
84.2%
219/260 • Number of events 527 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
80.0%
208/260 • Number of events 464 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Pyrexia
|
75.0%
195/260 • Number of events 364 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
68.8%
179/260 • Number of events 297 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
63.1%
164/260 • Number of events 275 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Nervous system disorders
Somnolence
|
92.3%
240/260 • Number of events 598 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
91.2%
237/260 • Number of events 544 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
86.5%
225/260 • Number of events 553 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
General disorders
Swelling
|
89.2%
232/260 • Number of events 610 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
84.6%
220/260 • Number of events 559 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
81.2%
211/260 • Number of events 516 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Infections and infestations
Viral infection
|
3.8%
10/260 • Number of events 12 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
9.2%
24/260 • Number of events 24 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
3.8%
10/260 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
13/260 • Number of events 14 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.2%
16/260 • Number of events 20 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
3.8%
10/260 • Number of events 10 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.3%
19/260 • Number of events 21 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
3.8%
10/260 • Number of events 11 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
6.5%
17/260 • Number of events 17 • Solicited local and general symptoms: during the 4-day (Days 0-3) post-primary and post-booster vaccination; Unsolicited AEs: during the 31-day (Days 0-30) post-primary and post-booster vaccination; SAEs: during the entire study period (up to Month 21).
|
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