Diphtheria, Haemophilus Influenzae Type b, Hepatitis B, Pertussis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, whooping cough, Haemophilus influenzae type b, Hepatitis B, Poliomyelitis
Brief summary
The study aims to confirm that, in Peruvian infants, the investigational DTaP-IPV Hep B-PRP\ T vaccine has immunological and safety profiles that are comparable to those of the control vaccine that is already marketed (Infanrix®Hexa) Primary Objective: To demonstrate that the hexavalent DTaP-IPV-Hep B-PRP\ T combined vaccine induces an immune response that is at least as good as the response following Infanrix®Hexa in terms of seroprotection rates to HB, one month after a three-dose primary series (2, 4 and 6 months) Secondary Objectives: * To describe in each group the immunogenicity to vaccine components (for DTaP-IPV-Hep B-PRP\ T and Infanrix®Hexa) one month after the third dose of the primary series. * To assess the overall safety in each group one month after each dose of the primary series and through the entire study.
Detailed description
The present trial will involve two-month old Peruvian infants, randomly assigned to receive three doses of either the investigational or the control vaccine at 2, 4, and 6 months of age.
Interventions
BIOLOGICALDTaP IPV HB PRP~T vaccine
0.5 mL, Intramuscular
BIOLOGICALDTaP-HB-IPV and Haemophilus influenzae type b
0.5 mL, Intramuscular
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
50 Days to 71 Days
Healthy volunteers
Yes
Inclusion criteria
: * Two month old infant (50 to 71 days old) on the day of inclusion, of either gender * Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg * Mother negative for Hepatitis B surface Antigen (HBsAg) in approximately the last 30 days of pregnancy (≥ 36 weeks of amenorrhea) or in the 30 days post partum * Informed consent form signed by both parents. If one or both parent(s) are under 18 years of age, the subject's grandparent(s) should also sign. An independent witness should also sign if the parent(s)/grandparent(s) are illiterate * Able to attend all scheduled visits and to comply with all trial procedures * Received Bacillus Calmette Guerin (BCG) vaccine between birth and one month of life in agreement with the national immunization calendar.
Exclusion criteria
: * Participation in another clinical trial in the 4 weeks preceding the first trial vaccination * Planned participation in another clinical trial during the present trial period * Known 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 * Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the last four weeks * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received since birth * Any vaccination in the 4 weeks preceding the first trial vaccination * Any planned vaccination during the trial (until Visit 06), except the study vaccines, rotavirus vaccine and pneumococcal conjugate vaccines * Documented history of pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) (confirmed either clinically, serologically, or microbiologically) * Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, hepatitis B or Haemophilus influenzae type b infection(s) * Known personal or maternal history of Human Immunodeficiency Virus, hepatitis B or hepatitis C seropositivity * Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination * History of seizures * Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ | Day 150 (1 month after dose 3) | Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL. |
| Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Day 150 (1 month after dose 3) | Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Day 150 (1 month after dose 3) | Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. |
| Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Day 0 up to Day 7 after each injection | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia \> 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable. |
Countries
Peru
Participant flow
Recruitment details
Participants were enrolled from 23 May 2008 to 18 July 2008 at 1 clinical center in Peru.
Pre-assignment details
A total of 263 participants who met the inclusion and exclusion criteria were randomized and vaccinated in the study.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-Hep B-PRP~T Group All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\
T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively. | 132 |
| Infanrix Hexa™ Group All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively. | 131 |
| Total | 263 |
Baseline characteristics
| Characteristic | Infanrix Hexa™ Group | DTaP-IPV-Hep B-PRP~T Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 131 Participants | 132 Participants | 263 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 | 1.72 Months STANDARD_DEVIATION 0.123 | 1.75 Months STANDARD_DEVIATION 0.132 | 1.74 Months STANDARD_DEVIATION 0.128 |
| Region of Enrollment Peru | 131 Participants | 132 Participants | 263 Participants |
| Sex: Female, Male Female | 74 Participants | 58 Participants | 132 Participants |
| Sex: Female, Male Male | 57 Participants | 74 Participants | 131 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 102 / 132 | 106 / 131 |
| serious Total, serious adverse events | 3 / 132 | 2 / 131 |
Outcome results
Primary
Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™
Anti-hepatitis B (Hep B) antibodies were measured by chemiluminescence detection. Seroprotection was defined as a titer ≥ 10 mIU/mL.
Time frame: Day 150 (1 month after dose 3)
Population: Seroprotection against Hep B was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ | 131 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection for Anti Hep-B After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ | 130 Participants |
Primary
Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria. Seroprotection criteria were defined as: Criteria 1: Anti-Hep B titer ≥ 10 mIU/mL; Anti-PRP titer ≥ 0.15 µg/mL; Anti-diphtheria titer ≥ 0.01 IU/mL. Criteria 2: Anti-Hep B titer ≥ 100 mIU/mL; Anti-PRP titer ≥ 1 µg/mL; Anti-diphtheria titer or ≥ 0.1 IU/mL.
Time frame: Day 150 (1 month after dose 3)
Population: Seroprotection was assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Hep B (Criteria 1) | 131 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Hep B (Criteria 2) | 124 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-PRP (Criteria 1) | 132 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-PRP (Criteria 2) | 112 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Diphtheria (Criteria 1) | 126 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Diphtheria (Criteria 2) | 77 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Diphtheria (Criteria 1) | 130 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Hep B (Criteria 1) | 130 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-PRP (Criteria 2) | 109 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Hep B (Criteria 2) | 129 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-Diphtheria (Criteria 2) | 85 Participants |
| Infanrix Hexa™ Group | Number of Participants Achieving Seroprotection to Vaccine Antigens After a Primary Series Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti-PRP (Criteria 1) | 129 Participants |
Secondary
Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Antibody titers were measured by chemiluminescence detection for hepatitis B (Hep B), by Farr type radioimmunoassay for Haemophilus influenzae type b (PRP), and by toxin neutralization test for diphtheria.
Time frame: Day 150 (1 month after dose 3)
Population: Antibody GMTs were assessed in all participants who did not have any protocol violation that might have interfered with primary criteria evaluation (Per-Protocol Population).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti Hep B | 986 Titers (1/dilutions) |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti PRP | 5.22 Titers (1/dilutions) |
| DTaP-IPV-Hep B-PRP~T Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti Diphtheria | 0.156 Titers (1/dilutions) |
| Infanrix Hexa™ Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti Hep B | 1139 Titers (1/dilutions) |
| Infanrix Hexa™ Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti PRP | 3.93 Titers (1/dilutions) |
| Infanrix Hexa™ Group | Geometric Mean Titers (GMTs) of Antibodies to Vaccine Antigens After a Primary Series of Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anti Diphtheria | 0.192 Titers (1/dilutions) |
Secondary
Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine.
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 reactions were defined as: Pain, cries when injected limb is moved or movement of injected limb is reduced; Erythema and Swelling ≥ 5 cm; Pyrexia \> 39.5ºC; Vomiting ≥ 6 episodes per 24 hour or requiring parenteral hydration; Crying, \> 3 hours; Somnolence, sleeping most of the time or difficult to wake up; Anorexia refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability inconsolable.
Time frame: Day 0 up to Day 7 after each injection
Population: Solicited reactions were assessed in all participants who received at least one dose of investigational or control vaccine, according to the vaccine actually received (Safety Analysis Population).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Vomiting Post Injection 3 | 6 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Erythema Post Injection 2 | 48 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Vomiting Post Any Injection | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 3 | 28 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 1 | 81 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Pain Post Any Injection | 10 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 2 | 57 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Swelling Post Any Injection | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 3 | 43 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | ErythemaPost Injection 3 | 45 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Crying Post Any Injection | 1 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 1 | 11 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 1 | 55 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 3 | 53 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 2 | 41 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 2 | 21 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 3 | 23 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Erythema Post Any Injection | 3 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Somnolence Post Any Injection | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 3 | 18 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Anorexia Post Injection 1 | 35 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Erythema Post Injection 1 | 32 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anorexia Post Injection 2 | 24 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Gade 3 Pyrexia Post Any Injection | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anorexia Post Injection 3 | 24 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 1 | 34 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Anorexia Post Any Injection | 0 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Vomiting Post Injection 1 | 20 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 1 | 85 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 2 | 68 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 2 | 63 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Vomiting Post Injection 2 | 8 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 3 | 40 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 2 | 26 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Irritability Post Any Injection | 2 Participants |
| DTaP-IPV-Hep B-PRP~T Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 1 | 82 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Irritability Post Any Injection | 1 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 1 | 71 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 2 | 68 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pain Post Injection 3 | 55 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Pain Post Any Injection | 6 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Erythema Post Injection 1 | 16 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Erythema Post Injection 2 | 30 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | ErythemaPost Injection 3 | 46 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Erythema Post Any Injection | 5 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 1 | 12 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 2 | 24 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Swelling Post Injection 3 | 32 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Swelling Post Any Injection | 2 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 1 | 11 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 2 | 17 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Pyrexia Post Injection 3 | 18 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Gade 3 Pyrexia Post Any Injection | 3 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Vomiting Post Injection 1 | 24 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Vomiting Post Injection 2 | 6 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Vomiting Post Injection 3 | 10 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Vomiting Post Any Injection | 0 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 1 | 68 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 2 | 52 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Crying Post Injection 3 | 47 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Crying Post Any Injection | 1 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 1 | 65 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 2 | 37 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Somnolence Post Injection 3 | 28 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Somnolence Post Any Injection | 2 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Any Anorexia Post Injection 1 | 42 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anorexia Post Injection 2 | 22 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Anorexia Post Injection 3 | 25 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Grade 3 Anorexia Post Any Injection | 1 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 1 | 81 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 2 | 65 Participants |
| Infanrix Hexa™ Group | Number of Participants Reporting Solicited Injection Site or Solicited Systemic Reactions After Vaccination With Either DTaP-IPV-Hep B-PRP~T or Infanrix Hexa™ Vaccine. | Irritability Post Injection 3 | 55 Participants |