Hepatitis B, Polio, Diphtheria, Pertussis, Haemophilus Influenzae Type b
Conditions
Keywords
Hepatitis B, Polio, Diphtheria, Pertussis, H. influenzae type b
Brief summary
The purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule The primary objective is to demonstrate that the hexavalent DTaP-IPV-HB-PRP\ T combined vaccine does not induce lower immune responses than CombAct-HIB® with Engerix B® Paediatric and OPV in terms of seroprotection rates to Diphtheria (D), Tetanus (T), polio, Hepatitis B (HB), and Polyribosyl ribitol phosphate (PRP), one month after a 3-dose primary series (6, 10, and 14 weeks) with no HB vaccination at birth. The secondary Objectives are: To describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. To describe Immunogenicity after the primary series and prior to and after a booster vaccination.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
BIOLOGICALCombAct-HIB®
0.5 mL, IM
BIOLOGICALEngerix B® Pediatric
0.5 mL, IM
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 3 Days
Healthy volunteers
Yes
Inclusion criteria
* 0 to 3 day old infants * Mother seronegative for Human Immunodeficiency Virus (HIV) * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Apgar score \>7 at 5 or 10 minutes of life * Informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Current or planned participation in another clinical trial during the entire duration of the present trial * Suspected congenital or acquired immunodeficiency * Suspected maternal acute seroconversion syndrome to HIV after 24 weeks gestation based on clinical history * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received since birth * Any planned vaccination (except Bacille Calmette Guérin and trial vaccinations) from birth to 18 weeks of age * Oral Poliovirus Vaccine (OPV) administration at birth * Known maternal history of HIV, Hepatitis B (HB) (HbsAg carrier) or Hepatitis C seropositivity * Thrombocytopenia or bleeding disorder contraindicating intramuscular (IM) vaccination * History of seizures * Febrile or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | 1 month post-Dose 3 | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Day 42 before Dose 1 and 1 month post-Dose 3 | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. |
| Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Day 540 pre-booster and Day 570 post-booster | Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA. |
| Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | 1 month post-Dose 3 | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline. |
| Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Day 0 up to Day 7 post each dose | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable. |
| Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Day 0 up to 7 post-booster vaccination | Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable. |
| Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Day 540 pre-booster and Day 570, post-booster | Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. |
Countries
South Africa
Participant flow
Recruitment details
Participants were enrolled from 28 August 2006 to 11 February 2007 in 2 clinical centers in South Africa.
Pre-assignment details
A total of 622 of the 715 recruited participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-Hep B-PRP~T Group Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age. | 243 |
| CombAct-Hib™ + Engerix B™ + OPV Group Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age. | 242 |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age. | 137 |
| Total | 622 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Serious Adverse Event | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 3 | 3 | 1 |
Baseline characteristics
| Characteristic | CombAct-Hib™ + Engerix B™ + OPV Group | DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | DTaP-IPV-Hep B-PRP~T Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 242 Participants | 137 Participants | 243 Participants | 622 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.07 Days STANDARD_DEVIATION 0.762 | 1.11 Days STANDARD_DEVIATION 0.773 | 1.04 Days STANDARD_DEVIATION 0.729 | 1.07 Days STANDARD_DEVIATION 0.751 |
| Region of Enrollment South Africa | 242 Participants | 137 Participants | 243 Participants | 622 Participants |
| Sex: Female, Male Female | 118 Participants | 68 Participants | 131 Participants | 317 Participants |
| Sex: Female, Male Male | 124 Participants | 69 Participants | 112 Participants | 305 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 202 / 243 | 210 / 242 | 119 / 137 |
| serious Total, serious adverse events | 7 / 243 | 6 / 242 | 5 / 137 |
Outcome results
Primary
Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti-Diphtheria (D) by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Poliovirus types 1, 2, and 3 by neutralization assay. Seroprotection was defined as the following antibody titers: Anti-Tetanus ≥ 0.01 International Unit (IU)/mL; Anti-Diphtheria ≥ 0.01 IU/mL; Anti-Hepatitis B ≥ 10 mIU/mL; Anti-Polyribosyl ribitol phosphate ≥ 0.15 µg/mL; Anti-polio 1, 2, and 3 ≥ 8 (1/dil).
Time frame: 1 month post-Dose 3
Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 (N = 182, 179, 98) | 182 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 209 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 (N = 186, 187, 104) | 186 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 (N = 196, 192, 113) | 193 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus (N = 213, 210, 122) | 213 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 176 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria (N = 206, 206, 122) | 201 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 (N = 186, 187, 104) | 174 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 (N = 196, 192, 113) | 192 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria (N = 206, 206, 122) | 198 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 (N = 182, 179, 98) | 176 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 185 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 212 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus (N = 213, 210, 122) | 210 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 (N = 182, 179, 98) | 98 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 97 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria (N = 206, 206, 122) | 116 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus (N = 213, 210, 122) | 122 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 119 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 (N = 186, 187, 104) | 103 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Seroprotection After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 (N = 196, 192, 113) | 111 Participants |
Secondary
Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio-immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
Time frame: Day 42 before Dose 1 and 1 month post-Dose 3
Population: GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Post-dose 3 (N = 178, 153, 99) | 207 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-dose 3 (N = 206, 206, 122) | 0.074 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Pre-dose 1 (N = 192, 175, 107) | 9.27 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 Post-dose 3 (N = 186, 187, 104) | 579 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Post-dose 3 (N = 213, 210, 122) | 1.51 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B Post-dose 3 (N = 184, 194, 98) | 330 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Post-dose 3 (N = 192, 156, 108) | 332 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 Post-dose 3 (N = 182, 179, 98) | 975 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Pre-Dose 1 (N = 192, 174, 118) | 7.77 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 Post-dose 3 (N = 196, 192, 113) | 620 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP Post-dose 3 (N = 219, 212, 122) | 3.31 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Post-dose 3 (N = 213, 210, 122) | 1.88 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Post-dose 3 (N = 192, 156, 108) | 191 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Pre-dose 1 (N = 192, 175, 107) | 8.02 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B Post-dose 3 (N = 184, 194, 98) | 148 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP Post-dose 3 (N = 219, 212, 122) | 5.18 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-dose 3 (N = 206, 206, 122) | 0.040 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 Post-dose 3 (N = 186, 187, 104) | 198 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 Post-dose 3 (N = 196, 192, 113) | 446 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 Post-dose 3 (N = 182, 179, 98) | 228 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Pre-Dose 1 (N = 192, 174, 118) | 7.66 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Post-dose 3 (N = 178, 153, 99) | 37.4 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 2 Post-dose 3 (N = 196, 192, 113) | 371 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Pre-dose 1 (N = 192, 175, 107) | 8.30 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP Post-dose 3 (N = 219, 212, 122) | 3.83 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 3 Post-dose 3 (N = 182, 179, 98) | 811 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA Post-dose 3 (N = 178, 153, 99) | 188 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Pre-Dose 1 (N = 192, 174, 118) | 6.62 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Post-dose 3 (N = 213, 210, 122) | 1.33 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Post-dose 3 (N = 206, 206, 122) | 0.074 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Polio Type 1 Post-dose 3 (N = 186, 187, 104) | 557 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B Post-dose 3 (N = 184, 194, 98) | 1913 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PT Post-dose 3 (N = 192, 156, 108) | 288 Titers |
Secondary
Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), anti-Poliovirus types 1, 2, and 3 by neutralization assay, and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA.
Time frame: Day 540 pre-booster and Day 570, post-booster
Population: GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 51.3 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post/Pre Ratio (N = 192, 0, 112) | 88.7 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post/Pre Ratio (N = 203, 199, 115) | 89.0 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Pre (N=164, 141, 104) | 11.6 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 6411 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 116) | 68.5 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 30.5 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 161 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N=153, 133, 99) | 26.1 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 0.060 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post/Pre Ratio (N=179, 182, 103) | 32.4 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 9.37 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 7298 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 210 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post/Pre Ratio (N = 189, 199, 111) | 158 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 127 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 0.219 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 10.0 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 18.9 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post/Pre Ratio (N=178, 181, 105) | 59.0 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 570 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Post (N=187, 184, 109) | 288 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N = 204, 200, 116) | 0.757 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 6637 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 4630 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post/Pre Ratio (N=176, 180, 106) | 40.5 Titers |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post/Pre Ratio (N = 185, 192, 114) | 45.5 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post/Pre Ratio (N=178, 181, 105) | 2.27 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 0 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N = 204, 200, 116) | 1.19 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 0.027 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post/Pre Ratio (N = 189, 199, 111) | 123 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 0.311 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 8.23 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post/Pre Ratio (N = 185, 192, 114) | 26.5 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 151 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 329 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 103 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 246 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 114 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post/Pre Ratio (N=176, 180, 106) | 2.92 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post/Pre Ratio (N = 192, 0, 112) | 0 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 116) | 52.2 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post/Pre Ratio (N = 203, 199, 115) | 43.6 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 3.33 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 863 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post/Pre Ratio (N=179, 182, 103) | 3.82 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 315 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Pre (N=164, 141, 104) | 10.4 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Post (N=187, 184, 109) | 110 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N=153, 133, 99) | 10.6 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 5.43 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 211 Titers |
| CombAct-Hib™ + Engerix B™ + OPV Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 40.8 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 0.045 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 228 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post/Pre Ratio (N=179, 182, 103) | 23.2 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 116) | 63.1 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 127 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N = 204, 200, 116) | 0.631 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 25.1 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 5144 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post/Pre Ratio (N=176, 180, 106) | 41.2 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post/Pre Ratio (N = 192, 0, 112) | 191 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 44893 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Pre (N=164, 141, 104) | 12.0 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post/Pre Ratio (N=178, 181, 105) | 38.4 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 20.3 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti PT Post (N=187, 184, 109) | 235 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 142 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 472 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N=153, 133, 99) | 20.5 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 0.173 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 8.13 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post/Pre Ratio (N = 185, 192, 114) | 47.4 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post/Pre Ratio (N = 189, 199, 111) | 153 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 5346 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 7.00 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 191 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post/Pre Ratio (N = 203, 199, 115) | 97.4 Titers |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Geometric Mean Titers (GMTs) of Antibodies Pre- and Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 4190 Titers |
Secondary
Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Anti-Hepatitis B (Hep B) was measured by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (Hib) by Farr type radio immunoassay, anti diphtheria by toxin neutralization assay, anti-Tetanus (T) by indirect enzyme-linked immunosorbent assay (ELISA), and anti-Pertussis toxoid (PT) and anti-Filamentous hemagglutinin (FHA) by ELISA. Seroprotection was defined as a titer ≥ 100 mIU/mL for anti-Hep B; ≥ 1 µg/mL for anti-PRP; ≥ 0.1 IU/mL (Level 1) and ≥ 1.0 IU/mL (Level 2) for anti-Diphtheria and anti-Tetanus. Seroconversion for anti-PT and anti-FHA was a ≥ 4-fold increase from baseline.
Time frame: 1 month post-Dose 3
Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 174 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA (N = 160, 130, 90) | 149 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 1 ( N = 206, 206, 122) | 82 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 145 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Pertussis Toxoid (N = 172, 137, 103) | 161 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 2 (N = 213, 210, 122) | 158 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 2 (N = 206, 206, 122) | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 1 (N = 213, 210, 122) | 213 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 127 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 2 (N = 206, 206, 122) | 0 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 2 (N = 213, 210, 122) | 173 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA (N = 160, 130, 90) | 75 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 196 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 1 ( N = 206, 206, 122) | 28 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 1 (N = 213, 210, 122) | 210 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Pertussis Toxoid (N = 172, 137, 103) | 114 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 2 (N = 206, 206, 122) | 4 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Diphtheria Level 1 ( N = 206, 206, 122) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 2 (N = 213, 210, 122) | 83 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-FHA (N = 160, 130, 90) | 81 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Pertussis Toxoid (N = 172, 137, 103) | 98 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Hep B (N = 184, 194, 98) | 95 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-Tetanus Level 1 (N = 213, 210, 122) | 122 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants Attaining Other Seroprotection and Seroconversion Titers After Primary Series Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anti-PRP (N = 219, 212, 122) | 97 Participants |
Secondary
Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV
Antibodies were measured by the following methods: anti-Hepatitis B (Hep B) by enhanced chemiluminescence detection, anti-Haemophilus influenzae type b (PRP) by Farr type radio immunoassay, anti-Diphtheria by toxin neutralization assay, anti-Tetanus by indirect enzyme-linked immunosorbent assay (ELISA), anti-poliovirus types 1, 2, and 3 by neutralization assay. Persistence and response were defined as a titer ≥ 10 mIU/mL for anti-Hep B, ≥ 0.15 µg/mL for anti-PRP, ≥ 0.01 IU/mL for anti-Diphtheria and anti-Tetanus, ≥ 8 (1/dil) for anti-Poliovirus, and ≥ 4 EU/mL for anti-PT and anti-FHA.
Time frame: Day 540 pre-booster and Day 570 post-booster
Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 157 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N =2 04, 200, 116) | 166 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 170 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 186 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 195 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N = 153, 133, 99) | 145 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 189 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 184 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 115) | 203 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 200 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 188 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 184 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 185 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Pre (N = 164, 141, 104) | 151 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 189 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 145 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post (N= 187, 184, 109) | 187 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 187 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 194 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 191 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post (N= 187, 184, 109) | 173 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 190 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 115) | 201 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 185 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 185 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N = 153, 133, 99) | 111 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Pre (N = 164, 141, 104) | 100 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 99 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 183 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 190 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 138 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 0 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N =2 04, 200, 116) | 185 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 173 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 200 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 195 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 199 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 178 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 186 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 190 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post/Pre Ratio (N = 159, 143, 94) | 89 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Post (N = 195, 200, 111) | 111 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post (N= 187, 184, 109) | 109 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Pre (N = 199, 199, 113) | 107 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Pre (N =2 04, 200, 116) | 88 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PRP Post (N = 203, 201, 115) | 115 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Diphtheria Pre (N = 197, 201, 116) | 98 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Pre (N = 189, 195, 116) | 116 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Tetanus Post (N = 200, 199, 114) | 114 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Pre (N = 190, 189, 112) | 108 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 1 Post (N = 189, 191, 108) | 108 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Pre (N = 190, 191, 111) | 109 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 2 Post (N = 191, 190, 107) | 107 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Pre (N = 189, 189, 111) | 110 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Polio Type 3 Post (N = 188, 187, 108) | 108 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Pre (N = 164, 141, 104) | 95 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-PT Post/Pre Ratio (N = 153, 133, 99) | 93 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Pre (N = 173, 148, 103) | 102 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-FHA Post (N = 184, 190, 105) | 105 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Antibody Persistence Pre-Booster and Response Post-Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + OPV | Anti-Hep B Post (N = 197, 0, 113) | 113 Participants |
Secondary
Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV).
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain - crying when injected limb is moved or the movement reduced; Erythema and Swelling - ≥ 5 cm; Fever - temperature ≥ 39.0ºC; Vomiting - ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying abnormal - \> 3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability - inconsolable.
Time frame: Day 0 up to Day 7 post each dose
Population: Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received - Safety Analysis Population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 3 (N = 231, 232, 134) | 94 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 3 (N = 231, 233, 134) | 106 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Swelling Post-Any Dose (N = 236, 238, 136) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 2 (N = 234, 232, 134) | 114 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Crying Post-Any Dose (N = 236, 238, 135) | 15 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 2 (N = 233, 230, 133) | 88 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 3 (N = 231, 232, 134) | 64 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 1 (N = 232, 238, 133) | 100 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 1 (N = 234, 238, 132) | 50 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 2 (N = 234, 232, 134) | 66 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 2 (N = 234, 232, 134) | 79 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pyrexia Post-Any Dose (N = 236, 238, 136) | 4 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 1 (N = 233, 238, 134) | 62 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 3 (N = 231, 232, 134) | 72 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Somnolence Post-Any Dose (N=236, 238, 135) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 1 (N = 233, 237, 132) | 112 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 2 (N = 234, 233, 134) | 52 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 1 (N = 233, 238, 133) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Erythema Post-Any Dose (N = 236, 238, 135) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 3 (N = 231, 233, 134) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 3 (N = 230, 232, 134) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 3 (N = 231, 234, 132) | 103 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 1 (N = 231, 238, 134) | 87 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 2 (N = 232, 231, 133) | 116 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pain Post-Any Dose (N = 237, 238, 136) | 17 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Anorexia Post-Any Dose (N=236, 238, 136) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 2 (N = 234, 233, 134) | 171 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 3 ( N = 232, 234, 134) | 143 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 1 (N=234, 238, 132) | 128 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 1 (N = 234, 237, 134) | 166 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Vomiting Post-Any Dose (N = 236, 238, 135) | 14 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grd 3 Irritability Post-Any Dose (N=236, 238, 135) | 18 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 1 (N = 234, 238, 133) | 138 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 2 (N = 234, 232, 134) | 43 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 2 (N = 234, 233, 134) | 131 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 3 (N = 232, 232, 133) | 74 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 3 (N = 231, 233, 134) | 49 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Erythema Post-Any Dose (N = 236, 238, 135) | 15 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 1 (N = 231, 238, 134) | 102 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 1 (N = 234, 238, 132) | 38 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 2 (N = 234, 232, 134) | 35 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pyrexia Post-Any Dose (N = 236, 238, 136) | 1 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Vomiting Post-Any Dose (N = 236, 238, 135) | 7 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 3 (N = 231, 232, 134) | 69 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Anorexia Post-Any Dose (N=236, 238, 136) | 13 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 1 (N = 234, 238, 133) | 154 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 2 (N = 234, 233, 134) | 135 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 3 (N = 231, 233, 134) | 116 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Crying Post-Any Dose (N = 236, 238, 135) | 20 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 1 (N = 232, 238, 133) | 103 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 2 (N = 234, 232, 134) | 90 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Somnolence Post-Any Dose (N=236, 238, 135) | 9 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 1 (N = 233, 238, 134) | 87 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 2 (N = 234, 232, 134) | 68 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 3 (N = 231, 232, 134) | 76 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 1 (N=234, 238, 132) | 137 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 2 (N = 234, 232, 134) | 118 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 3 (N = 231, 232, 134) | 99 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grd 3 Irritability Post-Any Dose (N=236, 238, 135) | 16 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 2 (N = 234, 233, 134) | 171 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 3 ( N = 232, 234, 134) | 162 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pain Post-Any Dose (N = 237, 238, 136) | 24 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 1 (N = 233, 237, 132) | 133 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 2 (N = 232, 231, 133) | 114 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 3 (N = 231, 234, 132) | 106 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 2 (N = 233, 230, 133) | 109 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 3 (N = 232, 232, 133) | 89 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Swelling Post-Any Dose (N = 236, 238, 136) | 10 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 3 (N = 230, 232, 134) | 34 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 1 (N = 233, 238, 133) | 59 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 2 (N = 234, 233, 134) | 56 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 1 (N = 234, 237, 134) | 177 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 3 (N = 231, 233, 134) | 31 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 1 (N = 234, 238, 132) | 27 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 2 (N = 234, 233, 134) | 97 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Anorexia Post-Any Dose (N=236, 238, 136) | 5 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 2 (N = 233, 230, 133) | 43 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 3 (N = 231, 232, 134) | 39 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 2 (N = 234, 232, 134) | 18 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pain Post-Any Dose (N = 237, 238, 136) | 7 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Erythema Post-Any Dose (N = 236, 238, 135) | 2 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 1 (N = 233, 237, 132) | 69 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 2 (N = 234, 232, 134) | 39 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 1 (N = 233, 238, 133) | 30 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 2 (N = 232, 231, 133) | 59 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 1 (N = 234, 238, 133) | 91 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pyrexia Post-dose 3 (N = 230, 232, 134) | 21 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 3 (N = 231, 232, 134) | 43 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Erythema Post-dose 3 (N = 231, 234, 132) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Somnolence Post-Any Dose (N=236, 238, 135) | 8 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 2 (N = 234, 232, 134) | 47 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Vomiting Post-dose 2 (N = 234, 233, 134) | 35 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Anorexia Post-dose 1 (N = 233, 238, 134) | 42 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Somnolence Post-dose 1 (N = 232, 238, 133) | 57 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 1 (N = 231, 238, 134) | 48 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Crying Post-Any Dose (N = 236, 238, 135) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Swelling Post-Any Dose (N = 236, 238, 136) | 4 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 3 ( N = 232, 234, 134) | 83 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 1 (N=234, 238, 132) | 77 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 3 (N = 231, 233, 134) | 66 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Swelling Post-dose 3 (N = 232, 232, 133) | 39 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 2 (N = 234, 232, 134) | 66 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Crying Post-dose 2 (N = 234, 233, 134) | 74 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Pyrexia Post-Any Dose (N = 236, 238, 136) | 0 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Irritability Post-dose 3 (N = 231, 232, 134) | 53 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grade 3 Vomiting Post-Any Dose (N = 236, 238, 135) | 6 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Pain Post-dose 1 (N = 234, 237, 134) | 95 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site and Systemic Reactions After Primary Vaccination Series With With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV). | Grd 3 Irritability Post-Any Dose (N=236, 238, 135) | 5 Participants |
Secondary
Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV)
Solicited Injection Site Reactions: Pain, Erythema, Swelling, and Extensive swelling of vaccinated limb. Solicited System Reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 was defined as: Pain, crying when injected limb is moved or the movement reduced; Erythema and Swelling, ≥ 5 cm; Fever, temperature ≥ 39.0ºC; Vomiting, ≥ 6 episodes/24 hours or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refusing ≥ 3 feeds or refusing most feeds/meals; and Irritability, inconsolable.
Time frame: Day 0 up to 7 post-booster vaccination
Population: Solicited reactions were assessed in all participants who received at least 1 dose of investigational or reference vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Irritability | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pain | 138 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Irritability | 98 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Erythema | 102 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pain | 5 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Anorexia | 8 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Extensive swelling of vaccinated limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pyrexia | 61 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Vomiting | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pyrexia | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Vomiting | 22 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Swelling | 75 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Crying | 106 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Extensive swelling of vaccinated limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Crying | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Somnolence | 85 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Somnolence | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anorexia | 88 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Swelling | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Erythema | 3 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Crying | 115 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Swelling | 98 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Vomiting | 2 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Irritability | 1 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pain | 149 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pain | 4 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Erythema | 104 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Swelling | 11 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Extensive swelling of vaccinated limb | 0 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Extensive swelling of vaccinated limb | 0 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pyrexia | 50 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pyrexia | 2 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Vomiting | 28 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Erythema | 2 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Crying | 0 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Somnolence | 80 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Somnolence | 1 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anorexia | 99 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Anorexia | 4 Participants |
| CombAct-Hib™ + Engerix B™ + OPV Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Irritability | 103 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pyrexia | 2 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Irritability | 1 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Vomiting | 14 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pyrexia | 37 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Vomiting | 0 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Swelling | 5 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Pain | 1 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Pain | 84 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Erythema | 2 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Erythema | 54 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Irritability | 52 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Anorexia | 55 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Crying | 2 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Anorexia | 4 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Extensive swelling of vaccinated limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Crying | 58 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Somnolence | 43 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Extensive swelling of vaccinated limb | 0 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Swelling | 48 Participants |
| DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group | Number of Participants With Solicited Injection Site (Study Vaccine Site) and Systemic Reactions After Booster Vaccination With DTaP-IPV-Hep B-PRT~T (With or Without Engerix B™ at Birth) or CombAct Hib™ + Engerix B™ + Oral Polio Vaccine (OPV) | Grade 3 Somnolence | 1 Participants |