Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Infections
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b, Haemophilus Influenzae
Brief summary
The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP\ T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule. The primary objective is: * To demonstrate that the pentavalent DTaP-HB-PRP\ T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age. The secondary objectives are: * To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and * To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.
Interventions
BIOLOGICALDTaP-HB-PRP~T vaccine + OPV
0.5 mL, Intramuscular
BIOLOGICALTritanrix-HepB/Hib™ + OPV vaccine
0.5 mL, Intramuscular
BIOLOGICALOral Polio Vaccine
Oral co-administered with study vaccine
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 50 Days
Healthy volunteers
Yes
Inclusion criteria
* Six week old infants (42 to 50 days old) on the day of inclusion; of either gender. * Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate) * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
* Participation in another clinical trial in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Congenital or acquired immunodeficiency; immunosuppressive therapy such as long-term systemic corticosteroid therapy. * Chronic illness at a stage that could interfere with the conduct or completion of the trial * Blood or blood-derived products received since birth * HB vaccination since birth * Any vaccination in the four weeks preceding the first trial vaccination * Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial * Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically) * Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity * Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination * History of seizures * Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination. |
| Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150). |
| Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination. |
| Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 1 month post third vaccination | Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination. |
| Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 0 up to Day 7 after each vaccination | Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable. |
Countries
Philippines
Participant flow
Recruitment details
Participants were enrolled and treated from 07 July 2006 to 26 September 2006 in 2 clinical centers in the Philippines.
Pre-assignment details
A total of 379 participants who met all the inclusion and none of the exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV Participants received 3 doses of the DTaP-Hep B-PRP\
T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | 190 |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age. | 189 |
| Total | 379 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 189 Participants | 190 Participants | 379 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 6.31 Weeks STANDARD_DEVIATION 0.304 | 6.31 Weeks STANDARD_DEVIATION 0.308 | 6.31 Weeks STANDARD_DEVIATION 0.306 |
| Region of Enrollment Philippines | 189 Participants | 190 Participants | 379 Participants |
| Sex: Female, Male Female | 92 Participants | 101 Participants | 193 Participants |
| Sex: Female, Male Male | 97 Participants | 89 Participants | 186 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 123 / 190 | 152 / 189 |
| serious Total, serious adverse events | 17 / 190 | 10 / 189 |
Outcome results
Primary
Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Seroprotection was defined as titers ≥ 10 mIU/mL at 30 days after the third vaccination.
Time frame: 1 month post third vaccination
Population: Seroprotection to hepatitis H Antigen was assessed in the per-protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 146 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroprotection to Hepatitis H Antigen After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 167 Participants |
Secondary
Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity were assessed by means of enzyme immunoassay (EIA) for antibodies to the vaccine antigens 1 month after the third vaccination (Day 150).
Time frame: 1 month post third vaccination
Population: Geometric Mean Titers (GMTs) of Vaccine Antibodies were assessed in the per protocol population.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B (N = 184, 186) | 39.1 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP (N = 178, 185) | 2.35 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria (N = 184, 186) | 0.018 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus (N = 184, 186) | 1.30 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis (N = 183, 184) | 5.16 Titers |
| Group 1: DTaP-Hep B-PRP~T + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Filamentous Hemagglutinin (N = 184, 186) | 5.50 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis (N = 183, 184) | 5.84 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hepatitis B (N = 184, 186) | 86.2 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus (N = 184, 186) | 1.76 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP (N = 178, 185) | 7.82 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Filamentous Hemagglutinin (N = 184, 186) | 5.71 Titers |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Geometric Mean Titers (GMTs) of Vaccine Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria (N = 184, 186) | 0.018 Titers |
Secondary
Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions defined as: Tenderness - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.6ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for \>3 hours; Somnolence - sleeping most of the time or difficulty to wake up; Anorexia - refuses ≥3 feeds; and Irritability - inconsolable.
Time frame: Day 0 up to Day 7 after each vaccination
Population: Safety was assessed on the safety analysis (intent-to-treat) population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post any vaccination | 123 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain post any vaccination | 7 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 1 | 100 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 2 | 86 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 3 | 62 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post any vaccination | 121 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injec. site Erythema post any vaccination | 2 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 1 | 70 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 2 | 70 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 3 | 76 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post any vaccination | 60 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injec. site Swelling post any vaccination | 4 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 1 | 41 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 2 | 28 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 3 | 24 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post any vaccination | 85 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Pyrexia post any vaccination | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 1 | 59 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 2 | 40 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 3 | 22 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post any vaccination | 43 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting post any vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 1 | 37 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 2 | 16 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 3 | 9 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post any vaccination | 56 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Crying post any vaccination | 0 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 1 | 41 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 2 | 29 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 3 | 16 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post any vaccination | 52 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence post any vaccination | 2 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 1 | 43 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 2 | 24 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 3 | 10 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post any vaccination | 48 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia post any vaccination | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 1 | 32 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 2 | 20 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 3 | 16 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post any vaccination | 102 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability post any vaccination | 4 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 1 | 90 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 2 | 48 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 3 | 32 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 1 | 40 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post any vaccination | 152 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 3 | 27 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain post any vaccination | 24 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 2 | 24 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 1 | 142 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 3 | 18 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 2 | 109 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post-vaccination 3 | 13 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post-vaccination 3 | 88 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 1 | 116 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post any vaccination | 148 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post any vaccination | 97 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injec. site Erythema post any vaccination | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post any vaccination | 67 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 1 | 89 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Crying post any vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 2 | 105 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post any vaccination | 128 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema post-vaccination 3 | 104 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 1 | 71 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post any vaccination | 107 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia post any vaccination | 1 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injec. site Swelling post any vaccination | 7 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 2 | 42 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 1 | 89 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 3 | 56 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 2 | 57 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 3 | 34 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling post-vaccination 3 | 49 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 1 | 50 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post any vaccination | 129 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post any vaccination | 63 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Pyrexia post any vaccination | 4 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability post any vaccination | 7 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 1 | 106 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence post any vaccination | 2 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 2 | 54 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 2 | 25 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Pyrexia post-vaccination 3 | 51 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 1 | 49 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting post any vaccination | 61 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 2 | 71 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting post any vaccination | 0 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site and Systemic Reaction Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 2 | 26 Participants |
Secondary
Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity was assessed by means of radioimmunoassay (RIA) for Diphtheria and Tetanus antibodies. Anti-Diphtheria and anti-tetanus Responses were assayed at ≥ 0.01 IU/mL and at ≥ 0.1 IU/mL at 30 days after the third vaccination.
Time frame: 1 month post third vaccination
Population: Anti-Hepatitis B Responses was assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria ≥ 0.01 IU/mL | 137 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria ≥ 0.1 IU/mL | 13 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus ≥ 0.01 IU/mL | 184 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus ≥ 0.1 IU/mL | 184 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus ≥ 0.1 IU/mL | 186 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria ≥ 0.01 IU/mL | 134 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus ≥ 0.01 IU/mL | 186 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Anti-Diphtheria and Anti-Tetanus Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria ≥ 0.1 IU/mL | 11 Participants |
Secondary
Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Immunogenicity was assessed by means of radioimmunoassay (RIA) for hepatitis B (HBs) antibodies. Anti-Hepatitis B Responses was defined as titers ≥ 100 mIU/mL at 30 days after the third vaccination.
Time frame: 1 month post third vaccination
Population: Anti-Hepatitis B Responses was assessed in the per-protocol population.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 54 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Anti-Hepatitis B Responses After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With Oral Polio Vaccine (OPV) or Tritanrix-Hep B/Hib™ Concomitantly With OPV | 97 Participants |
Secondary
Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Anti-Pertussis toxoid and Anti-Filamentous Hemagglutinin antibodies were assessed by means of enzyme immunoassay (EIA). Seroconversion was defined as ≥ 4 fold increase in antibody titers from Day 0 to 30 days after the third vaccination.
Time frame: 1 month post third vaccination
Population: Seroconversion for anti-Pertussis toxoid and anti-Filamentous Hemagglutinin antibodies were assessed in the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Toxoid (N =184, 180) | 183 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Filamentous Hemagglutinin (N = 178, 131) | 178 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Pertussis Toxoid (N =184, 180) | 168 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroconversion for Anti-Pertussis and Anti-Filamentous Hemagglutinin Antibodies After Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Filamentous Hemagglutinin (N = 178, 131) | 116 Participants |