Diphtheria, Hepatitis B, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B, Poliomyelitis, Invasive Haemophilus influenzae type b.
Brief summary
The purpose of this trial is to clinically confirm that the manufacturing process of the final bulk products of the investigational DTaP-IPV-HB-PRP\ T vaccine is consistent. The primary objective is to demonstrate the equivalence of three batches of DTaP-IPV-HB-PRP\ T vaccine, in terms of seroprotection and seroconversion rates for the vaccine antigens after the three-dose primary series. The secondary objectives are: * To describe in each group, the immunogenicity parameters for all antigens one month after the third dose of the primary series * To assess the overall safety in each group one month after the third dose of the primary series.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T vaccine
0.5 mL, intramuscular (IM)
BIOLOGICALDTaP-HBV-IPV vaccine
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
: * Two months old infants on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by one or both parents or by the guardian and two independent witnesses * Able to attend all scheduled visits and to comply with all trial procedures * Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
Exclusion criteria
: * Participation in another clinical trial in the four weeks preceding the (first) trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency * Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received since birth * Any vaccination in the four weeks preceding the first trial visit * Any planned vaccination (except BCG, rotavirus, and pneumococcal conjugated vaccines) during the study * Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) * Previous vaccination against hepatitis B, pertussis, tetanus, diphtheria, poliovirus, or Haemophilus influenzae type b infection(s) * Known personal or maternal history of HIV, Hepatitis B (HBsAg) or Hepatitis C seropositivity * Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination * History of seizures * Febrile (rectal equivalent temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Day 150 (one month post-dose 3) | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies. |
| Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Day 150 (one month post-dose 3) | Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3. |
| Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Day 150 (one month post-dose 3) | Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Day 150 (one month post-dose 3) | Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). |
| Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Day 0 (pre-each vaccination) up to 7 days post-each dose | Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (\[pyrexia\] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability |
Countries
Mexico
Participant flow
Recruitment details
Participants were enrolled from 14 November 2006 to 13 July 2007 in 6 clinical centers in Mexico.
Pre-assignment details
A total of 1189 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\
T), with one dose each at 2, 4, and 6 months of age. | 340 |
| DTaP-IPV-HB-PRP~T Batch 2 Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\
T), with one dose each at 2, 4, and 6 months of age. | 343 |
| DTaP-IPV-HB-PRP~T Batch 3 Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP\
T), with one dose each at 2, 4, and 6 months of age. | 339 |
| Infanrix Hexa™ Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age. | 167 |
| Total | 1,189 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 15 | 11 | 13 | 10 |
| Overall Study | Protocol Violation | 10 | 5 | 14 | 5 |
| Overall Study | Serious Adverse Event | 0 | 0 | 2 | 0 |
| Overall Study | Withdrawal by Subject | 14 | 12 | 16 | 6 |
Baseline characteristics
| Characteristic | DTaP-IPV-HB-PRP~T Batch 2 | DTaP-IPV-HB-PRP~T Batch 3 | DTaP-IPV-HB-PRP~T Batch 1 | Infanrix Hexa™ | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 343 Participants | 339 Participants | 340 Participants | 167 Participants | 1189 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 2.00 Months STANDARD_DEVIATION 0.197 | 2.01 Months STANDARD_DEVIATION 0.193 | 2.00 Months STANDARD_DEVIATION 0.2 | 1.98 Months STANDARD_DEVIATION 0.189 | 2.00 Months STANDARD_DEVIATION 0.195 |
| Region of Enrollment Mexico | 343 Participants | 339 Participants | 340 Participants | 167 Participants | 1189 Participants |
| Sex: Female, Male Female | 163 Participants | 167 Participants | 160 Participants | 82 Participants | 572 Participants |
| Sex: Female, Male Male | 180 Participants | 172 Participants | 180 Participants | 85 Participants | 617 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 220 / 337 | 237 / 345 | 225 / 340 | 95 / 167 |
| serious Total, serious adverse events | 5 / 337 | 5 / 345 | 12 / 340 | 6 / 167 |
Outcome results
Primary
Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA). Seroconversion was defined as a ≥ 4 fold increase in titer from Day 0 (before dose 1) to Day 150, one month post-dose 3.
Time frame: Day 150 (one month post-dose 3)
Population: Seroconversion was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-FHA (N= 227, 233, 221, 115) | 225 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Pertussis (N= 228, 234, 223, 118) | 223 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Pertussis (N= 228, 234, 223, 118) | 226 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-FHA (N= 227, 233, 221, 115) | 229 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Pertussis (N= 228, 234, 223, 118) | 218 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-FHA (N= 227, 233, 221, 115) | 216 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-FHA (N= 227, 233, 221, 115) | 111 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Pertussis in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Pertussis (N= 228, 234, 223, 118) | 113 Participants |
Primary
Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine
Antibody titers were measured for poliovirus types 1, 2, and 3 by Enzyme immuno assay. Seroprotection against Poliovirus Types 1, 2, and 3 was defined as a titer ≥ 8 (1/dilutions).
Time frame: Day 150 (one month post-dose 3)
Population: Seroprotection was assessed in all participants who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 230 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 236, 226, 119) | 229 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 230 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 236 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 236, 226, 119) | 235 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 236 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 226 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 225 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 236, 226, 119) | 226 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 119 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 236, 226, 119) | 117 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Poliovirus Types 1, 2, and 3 in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 118 Participants |
Primary
Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for Diphtheria (D) by toxin neutralization test, and for Tetanus (T) by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as a titer ≥ 0.10 mIU/mL for Hep B, ≥ 0.15 µg/mL for PRP, and ≥ 0.01 IU/mL for D and T antibodies.
Time frame: Day 150 (one month post-dose 3)
Population: Seroprotection was assessed in participants that received a vaccine who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population). Total number (N) are those with available data for the endpoint.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 220 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 229 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 231 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 236, 119) | 226 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 232 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 236, 119) | 231 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 228 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 236 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 222 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 226 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 227 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 236, 119) | 221 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 118 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 119 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 236, 119) | 119 Participants |
| Infanrix Hexa™ | Equivalence of Seroprotection Against Vaccine Antigens in Study Participants After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 118 Participants |
Secondary
Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Antibody titers were measured for hepatitis B (Hep B) by enhanced chemiluminescence detection, for Haemophilus influenzae type b (PRP) by Farr type radioimmunoassay, for diphtheria (D) by toxin neutralization test, and for tetanus by enzyme linked immunosorbent assay. Antibody titers were measured for poliovirus types 1, 2, and 3 by neutralization assay. Antibody titers were measured for pertussis toxoid (PT) and filamentous hemagglutinin (FHA) by enzyme linked immunosorbent assay (ELISA).
Time frame: Day 150 (one month post-dose 3)
Population: Geometric Mean Titers were assessed in all participants with endpoint data who did not have any protocol deviation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 11.9 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 0.176 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Pertusiss toxoid (N = 230, 235, 226, 119) | 242 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 1.90 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 1689 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-FHA (N = 230, 234, 226, 118) | 243 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 860 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 226, 119) | 935 Titers |
| DTaP-IPV-HB-PRP~T Batch 1 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 235, 226, 117) | 1198 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 226, 119) | 1566 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 13.1 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 235, 226, 117) | 1170 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 0.246 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 1.86 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 1665 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-FHA (N = 230, 234, 226, 118) | 256 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Pertusiss toxoid (N = 230, 235, 226, 119) | 238 Titers |
| DTaP-IPV-HB-PRP~T Batch 2 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 945 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 235, 226, 117) | 962 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Pertusiss toxoid (N = 230, 235, 226, 119) | 241 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-FHA (N = 230, 234, 226, 118) | 220 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 226, 119) | 1009 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 11.5 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 1.77 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 843 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 1612 Titers |
| DTaP-IPV-HB-PRP~T Batch 3 | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 0.173 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Tetanus (N = 231, 236, 227, 119) | 2.20 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-FHA (N = 230, 234, 226, 118) | 182 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 2 (N = 230, 236, 226, 118) | 2337 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 1 (N = 231, 236, 225, 119) | 1370 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Pertusiss toxoid (N = 230, 235, 226, 119) | 228 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-PRP (N = 231, 236, 228, 119) | 6.68 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Diphtheria (N = 231, 236, 228, 119) | 0.173 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Hep B (N = 230, 234, 226, 119) | 1576 Titers |
| Infanrix Hexa™ | Geometric Mean Titers of Antibodies After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anti-Polio 3 (N = 230, 235, 226, 117) | 2186 Titers |
Secondary
Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine
Solicited Injection Site Reactions: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Fever (\[pyrexia\] - temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability
Time frame: Day 0 (pre-each vaccination) up to 7 days post-each dose
Population: Solicited reactions were assessed in all subjects who received at least one dose of vaccine, according to the vaccine actually received (Safety Analysis Population). Two batch 1 subjects got batch 2 vaccine, and 1 batch 1 got batch 3 vaccine. Total number (N) are those with available data for the outcome
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 1 (N = 323, 336, 329, 155) | 220 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 2 (N = 310, 319, 316, 153) | 37 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 1 (N = 323, 336, 329, 156) | 68 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 2 (N = 310, 319, 315, 153) | 74 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 3 (N = 302, 317, 306, 149) | 61 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 3 (N = 302, 317, 306, 149) | 69 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 2 (N = 310, 318, 315, 153) | 75 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 3 (N = 302, 317, 306, 149) | 66 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 2 (N = 310, 319, 315, 153) | 56 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 1 (N = 323, 336, 329, 156) | 63 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Pos-dose 3 (N = 302, 317, 306, 149) | 188 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dse 3 (N = 302, 317, 306, 149) | 158 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 1 (N = 323, 336, 329, 156) | 62 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 3 (N = 302, 317, 306, 149) | 56 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema-Post dose 1 (N = 323, 336, 329, 156) | 92 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 2 (N = 310, 319, 316, 153) | 158 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dse 2 (N = 310, 319, 316, 153) | 69 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 1 (N = 323, 336, 329, 156) | 93 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 2 (N = 310, 319, 315, 153) | 94 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 1 (N = 323, 336, 329, 156) | 188 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 3 (N=302, 317, 306, 149) | 110 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 2 (N=310, 319, 316, 153) | 133 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 3 (N = 302, 317, 306, 149) | 95 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 2 (N = 310, 319, 316, 153) | 191 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 1 (N = 323, 336, 329, 156) | 160 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 3 (N = 302, 317, 306, 149) | 51 Participants |
| DTaP-IPV-HB-PRP~T Batch 1 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 1 (N = 323, 336, 329, 156) | 67 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 3 (N = 302, 317, 306, 149) | 57 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 1 (N = 323, 336, 329, 155) | 237 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 2 (N = 310, 319, 316, 153) | 220 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Pos-dose 3 (N = 302, 317, 306, 149) | 209 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema-Post dose 1 (N = 323, 336, 329, 156) | 97 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 2 (N = 310, 319, 315, 153) | 101 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 3 (N = 302, 317, 306, 149) | 94 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 1 (N = 323, 336, 329, 156) | 86 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 2 (N = 310, 319, 315, 153) | 70 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 3 (N = 302, 317, 306, 149) | 65 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 1 (N = 323, 336, 329, 156) | 77 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 2 (N = 310, 318, 315, 153) | 84 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 3 (N = 302, 317, 306, 149) | 85 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 1 (N = 323, 336, 329, 156) | 63 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 2 (N = 310, 319, 316, 153) | 46 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 3 (N = 302, 317, 306, 149) | 46 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 1 (N = 323, 336, 329, 156) | 156 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 2 (N=310, 319, 316, 153) | 145 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 3 (N=302, 317, 306, 149) | 118 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 1 (N = 323, 336, 329, 156) | 110 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dse 2 (N = 310, 319, 316, 153) | 78 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 1 (N = 323, 336, 329, 156) | 75 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 2 (N = 310, 319, 315, 153) | 64 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 3 (N = 302, 317, 306, 149) | 58 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 1 (N = 323, 336, 329, 156) | 198 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 2 (N = 310, 319, 316, 153) | 192 Participants |
| DTaP-IPV-HB-PRP~T Batch 2 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dse 3 (N = 302, 317, 306, 149) | 167 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 2 (N=310, 319, 316, 153) | 134 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 3 (N = 302, 317, 306, 149) | 47 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 2 (N = 310, 319, 315, 153) | 96 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Pos-dose 3 (N = 302, 317, 306, 149) | 198 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 2 (N = 310, 319, 316, 153) | 174 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 1 (N = 323, 336, 329, 156) | 70 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 1 (N = 323, 336, 329, 156) | 148 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 3 (N=302, 317, 306, 149) | 122 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 2 (N = 310, 319, 316, 153) | 34 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 2 (N = 310, 319, 315, 153) | 65 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 3 (N = 302, 317, 306, 149) | 101 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 3 (N = 302, 317, 306, 149) | 72 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 1 (N = 323, 336, 329, 155) | 225 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 1 (N = 323, 336, 329, 156) | 82 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 1 (N = 323, 336, 329, 156) | 102 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 1 (N = 323, 336, 329, 156) | 193 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 2 (N = 310, 319, 316, 153) | 199 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 2 (N = 310, 318, 315, 153) | 85 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema-Post dose 1 (N = 323, 336, 329, 156) | 97 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 2 (N = 310, 319, 315, 153) | 60 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 3 (N = 302, 317, 306, 149) | 54 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 3 (N = 302, 317, 306, 149) | 70 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dse 3 (N = 302, 317, 306, 149) | 165 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dse 2 (N = 310, 319, 316, 153) | 65 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 3 (N = 302, 317, 306, 149) | 65 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 1 (N = 323, 336, 329, 156) | 56 Participants |
| DTaP-IPV-HB-PRP~T Batch 3 | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 1 (N = 323, 336, 329, 156) | 80 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 1 (N = 323, 336, 329, 156) | 27 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 3 (N = 302, 317, 306, 149) | 29 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 2 (N = 310, 319, 316, 153) | 18 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 3 (N = 302, 317, 306, 149) | 43 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 1 (N = 323, 336, 329, 155) | 95 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Vomiting Post-dose 3 (N = 302, 317, 306, 149) | 20 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dse 3 (N = 302, 317, 306, 149) | 69 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 1 (N = 323, 336, 329, 156) | 62 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema Post-dose 2 (N = 310, 319, 315, 153) | 33 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 2 (N=310, 319, 316, 153) | 59 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 1 (N = 323, 336, 329, 156) | 83 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Crying Post-dose 3 (N=302, 317, 306, 149) | 40 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Erythema-Post dose 1 (N = 323, 336, 329, 156) | 41 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 1 (N = 323, 336, 329, 156) | 45 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dse 2 (N = 310, 319, 316, 153) | 24 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Pos-dose 3 (N = 302, 317, 306, 149) | 87 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Somnolence Post-dose 3 (N = 302, 317, 306, 149) | 20 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 1 (N = 323, 336, 329, 156) | 27 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pain Post-dose 2 (N = 310, 319, 316, 153) | 88 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Irritability Post-dose 2 (N = 310, 319, 316, 153) | 72 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 3 (N = 302, 317, 306, 149) | 22 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Anorexia Post-dose 2 (N = 310, 319, 315, 153) | 25 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 1 (N = 323, 336, 329, 156) | 17 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 2 (N = 310, 319, 315, 153) | 26 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 2 (N = 310, 318, 315, 153) | 32 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Pyrexia Post-dose 3 (N = 302, 317, 306, 149) | 28 Participants |
| Infanrix Hexa™ | Number of Participants Reporting Solicited Injection Site or Systemic Reactions After Vaccination With Either One of the Batches of DTaP-IPV-HB-PRP~T Vaccine or Infanrix Hexa™ Vaccine | Swelling Post-dose 1 (N = 323, 336, 329, 156) | 35 Participants |