Diphtheria, Hepatitis B, Influenza, Pertussis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Hepatitis B Hansenula (HB), Haemophilus influenzae type b
Brief summary
This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP\ T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.
Interventions
BIOLOGICALDTaP-HB-PRP~T combined vaccine
0.5 mL, Intramuscular
BIOLOGICALTritanrix-HepB/Hib™ vaccine
0.5 mL, Intramuscular
BIOLOGICALOral poliomyelitis vaccine (OPV)
Oral co-administered with study vaccine.
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 50 Days
Healthy volunteers
Yes
Inclusion criteria
At Screening: * 0 to 3 day old infants * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Apgar score ≥ 7 at three minutes after birth * Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate) At Inclusion: * Six weeks of age * Received a dose of Hepatitis B (HB) in the first three days of life * Able to attend all scheduled visits and to comply with all trial procedures.
Exclusion criteria
At Screening: * Illness at a stage that could interfere with trial conduct or completion * Any vaccination before HB vaccination (except bacille Calmette-Guérin \[BCG\] given at birth) * Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth) * Acute illness on the day of screening. At Screening and at Inclusion: * Blood or blood-derived products received since birth * Planned participation in another clinical trial during the present trial period * Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg) * Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B) At Inclusion: * Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG) * Participation in another clinical trial before the first trial vaccination * Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroid therapy * Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances * Chronic illness at a stage that could interfere with trial conduct or completion * Vaccination other than with the study vaccines planned in the 12 weeks following inclusion * Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically) * 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 for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria 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 | Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination. |
| Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Day 0 to Day 7 post-vaccination | Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination. |
| Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Day 0 to Day 7 after vaccination | Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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 17 May 2006 to 26 September 2006 in 1 clinic center in the Philippines.
Pre-assignment details
A total of 2133 participants who met the inclusion and 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 poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age. | 1,424 |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age. | 709 |
| Total | 2,133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 0 |
| Overall Study | Lost to Follow-up | 12 | 6 |
| Overall Study | Serious Adverse Event | 0 | 2 |
| Overall Study | Withdrawal by Subject | 3 | 4 |
Baseline characteristics
| Characteristic | Group 2: Tritanrix-Hep B/ Hib™ + OPV | Group 1: DTaP-Hep B-PRP~T + OPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 709 Participants | 1424 Participants | 2133 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 | 6.30 Weeks STANDARD_DEVIATION 0.31 | 6.27 Weeks STANDARD_DEVIATION 0.28 | 6.28 Weeks STANDARD_DEVIATION 0.291 |
| Region of Enrollment Philippines | 709 Participants | 1424 Participants | 2133 Participants |
| Sex: Female, Male Female | 356 Participants | 718 Participants | 1074 Participants |
| Sex: Female, Male Male | 353 Participants | 706 Participants | 1059 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1,092 / 1,425 | 636 / 708 |
| serious Total, serious adverse events | 31 / 1,425 | 12 / 708 |
Outcome results
Primary
Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV.
Occurence of at least one high fever episode (≥ 39.6ºC rectal temperature equivalent) observed within 7 days after any of the three injections.
Time frame: Day 0 to Day 7 post-vaccination
Population: Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received and with the total number (N) available for the endpoint at each time-point.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 1 (N = 1419, 705) | 3 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-any Vaccination (N = 1419, 705) | 5 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 2 (N = 1408, 698) | 1 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 3 (N = 1405, 698) | 1 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 3 (N = 1405, 698) | 4 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 2 (N = 1408, 698) | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-any Vaccination (N = 1419, 705) | 8 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Observed High Fever During the 7-Day After Vaccination With DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/ Hib™ Concomitantly With OPV. | Post-vaccination 1 (N = 1419, 705) | 1 Participants |
Primary
Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Seroprotection was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies, enzyme immunoassay (EIA) for anti-Tetanus, and serum neutralization (SN) for anti-Diphtheria. Seroprotection was defined as titers ≥ 10 mIU/mL for anti-Hep Bs; ≥ 0.15 μg/mL for anti-PRP; ≥ 0.01 IU/mL for anti-Tetanus and anti-Diphtheria at 30 days after the third vaccination.
Time frame: 1 month post third vaccination
Population: Seroprotection was assessed in a subset of participants available for the endpoint, the per-protocol population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep Bs (N = 246, 122) | 239 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP (N = 218, 122) | 210 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria (N = 246, 123) | 217 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus (N = 246,123) | 246 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Tetanus (N = 246,123) | 123 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Hep Bs (N = 246, 122) | 119 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-Diphtheria (N = 246, 123) | 109 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants With Seroprotection for Anti-Hep Bs, Anti-PRP, Anti-Tetanus, and Anti-Diphtheria Antibodies After Vaccination With Either DTaP-Hep B-PRP~T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anti-PRP (N = 218, 122) | 121 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 was assessed by means of radioimmunoassay (RIA) for anti-Hepatitis B (Hep Bs) and anti-PRP antibodies; enzyme immunoassay (EIA) for anti-Tetanus; serum neutralization (SN) for anti-Diphtheria; and enzyme-linked immunosorbent assay (ELISA) for anti-Pertusiss (PT) and anti-Filamentous Hemagglutinin (FHA) titers at Day 150, 1 month after the third vaccination.
Time frame: 1 month post third vaccination
Population: GMTs were assessed in a subset of the participants available for the endpoint, 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-Hep Bs (N = 246, 122) | 464 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 = 218, 121) | 3.02 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 = 246, 123) | 0.025 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 = 246, 123) | 1.05 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-Pertusiss (N = 245, 108) | 139 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 = 205, 94) | 86.7 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-Pertusiss (N = 245, 108) | 81.5 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-Hep Bs (N = 246, 122) | 343 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 = 246, 123) | 1.31 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 = 218, 121) | 10.3 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 = 205, 94) | 9.17 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 = 246, 123) | 0.023 Titers |
Secondary
Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV
Solicited injection site reactions: Pain, Erythema, and Swelling; Solicited systemic reactions; Fever (temperature), Vomiting, Abnormal Crying, Drowsiness, Loss of Appetite, and irritability. Grade 3 reactions are defined as: Pain - cries when injected limb is moved; Erythema and Swelling - ≥ 5cm; Fever - rectal 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 to Day 7 after vaccination
Population: Safety was assessed on the safety analysis (intent-to-treat) population. Two participants in Group 1 were given the Group 2 vaccine; 3 participants in Group 2 were given the Group 1 vaccine. The data were analyzed and presented according to the actual treatment received.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 1 | 193 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post any vaccination | 719 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 2 | 105 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 3 | 187 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 3 | 72 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Inject. site Swelling Post any vaccination | 15 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post any vaccination | 567 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 3 | 616 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Crying post any vaccination | 5 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 1 | 576 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 1 | 431 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain post any vaccination | 344 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 2 | 275 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 2 | 438 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 3 | 205 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post any vaccination | 794 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post any vaccination | 673 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 3 | 365 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence post any vaccination | 43 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 2 | 222 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 1 | 527 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 2 | 368 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post any vaccination | 523 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 3 | 255 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Inject. site Erythema Post any vaccination | 16 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post any vaccination | 396 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Fever Post any vaccination | 5 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia post any vaccination | 10 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 1 | 958 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 1 | 235 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 1 | 282 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 2 | 201 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 1 | 543 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 3 | 130 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post any vaccination | 1092 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post any vaccination | 945 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 2 | 448 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability post any vaccination | 33 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post any vaccination | 266 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 1 | 823 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 2 | 751 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 2 | 499 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting Post any vaccination | 2 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 3 | 369 Participants |
| Group 1: DTaP-Hep B-PRP~T + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 3 | 408 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 3 | 266 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 1 | 282 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain post any vaccination | 636 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Injection site Pain post any vaccination | 295 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 1 | 573 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 2 | 463 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Pain Post-vaccination 3 | 407 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post any vaccination | 497 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Inject. site Erythema Post any vaccination | 16 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 1 | 353 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 2 | 320 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post any vaccination | 503 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Inject. site Swelling Post any vaccination | 35 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 1 | 423 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 2 | 343 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Swelling Post-vaccination 3 | 288 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post any vaccination | 394 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Fever Post any vaccination | 8 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 1 | 248 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 2 | 165 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Fever Post-vaccination 3 | 156 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post any vaccination | 172 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Vomiting Post any vaccination | 3 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 1 | 118 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 2 | 83 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Vomiting Post-vaccination 3 | 52 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post any vaccination | 381 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With 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 Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 1 | 301 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 2 | 193 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Crying post-vaccination 3 | 152 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post any vaccination | 360 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Somnolence post any vaccination | 35 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 2 | 216 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Somnolence post-vaccination 3 | 150 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post any vaccination | 250 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Anorexia post any vaccination | 8 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 1 | 159 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 2 | 118 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Anorexia post-vaccination 3 | 97 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post any vaccination | 539 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Grade 3 Irritability post any vaccination | 32 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 1 | 471 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Irritability post-vaccination 2 | 331 Participants |
| Group 2: Tritanrix-Hep B/ Hib™ + OPV | Number of Participants Reporting At Least One Solicited Injection Site Reaction or Systemic Reactions Following Each Vaccination With Either DTaP-Hep B-PRP-T Concomitantly With OPV or Tritanrix-Hep B/Hib™ Concomitantly With OPV | Injection site Erythema Post-vaccination 3 | 283 Participants |