Diphtheria, Tetanus, Pertussis, Haemophilus Influenzae Type b, Hepatitis B
Conditions
Keywords
Diphtheria, Tetanus, Pertussis, Recombinant Hepatitis B, Poliomyelitis, Haemophilus influenzae type b, Tetanus protein
Brief summary
To demonstrate that DTaP-IPV-HB-PRP\ T combined vaccine does not induce a higher incidence rate of high fever than Tritanrix-HepB/Hib™ and Oral Polio Vaccine (OPV) after any of the three vaccinations at 2, 4, and 6 months of age for each subject. To evaluate the overall safety in terms of: Any solicited adverse reactions in the first 7 days after each injection, Any adverse events and reactions in the first 30 days after each injection, Any serious adverse events during the trial. Immunogenicity: To document the immune response to Hepatitis B antigen of the three batches of the investigational DTaP-IPV-HB-PRP\ T vaccine.
Interventions
BIOLOGICALDTaP-IPV-HB-PRP~T
0.5 mL, Intramuscular (IM)
BIOLOGICALTritanrix-HepB/Hib
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
* 2 months old infants on the day of inclusion * Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * Informed consent form signed by one or both parents or by the legally acceptable representative and 1 or 2 independent witnesses * Able to attend all scheduled visits and to comply with all trial procedures * Has complied with the national immunization calendar (BCG for both countries) for the first 2 months of life.
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 corticosteroids therapy * Subjects with congenital or acquired immunodeficiency in the child's surrounding * Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances * Chronic illness at a stage that could interfere with trial conduct or completion * Blood or blood-derived products received since birth * Any vaccination in the 4 weeks preceding the first trial vaccination * Vaccination planned in the 4 weeks following the trial vaccination * Documented history of pertussis, tetanus, diphtheria, poliomyelitis, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically) * Mother known as seropositive for HIV or Hepatitis C, or known carrier of Hepatitis B surface antigen * Previous vaccination against pertussis, tetanus, diphtheria, poliomyelitis, or Haemophilus influenzae type b infection(s) * Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating IM vaccination * History of seizures * Febrile or acute illness on the day of inclusion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Day 0 up to Day 7 post-injection | High fever was defined as rectal temperature equivalent to ≥ 39.6ºC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. |
| Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | Day 30 post-dose 3 | Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively. |
| Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Day 0 up to Day 7 Post-injection | Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable. |
Countries
Mexico, Peru
Participant flow
Recruitment details
Participants were enrolled and treated from 17 July 2006 to 02 January 2008 in 1 clinical center in Mexico and 1 clinical center in Peru.
Pre-assignment details
A total of 2133 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| DTaP-IPV-Hep B-PRP~T Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B \[recombinant DNA\]) and poliomyelitis (Inactivated \[IPV\]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP\
T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 1,422 |
| Tritanrix-Hep B/Hib™ + OPV Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age. | 711 |
| Total | 2,133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 3 |
| Overall Study | Did not meet age criteria | 1 | 1 |
| Overall Study | Lost to Follow-up | 27 | 14 |
| Overall Study | Protocol Violation | 19 | 10 |
| Overall Study | Serious adverse event | 6 | 1 |
| Overall Study | Withdrawal by Subject | 39 | 12 |
Baseline characteristics
| Characteristic | DTaP-IPV-Hep B-PRP~T | Tritanrix-Hep B/Hib™ + OPV | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1422 Participants | 711 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 Age Continuous | 1.89 Months STANDARD_DEVIATION 0.195 | 1.88 Months STANDARD_DEVIATION 0.197 | 1.88 Months STANDARD_DEVIATION 0.196 |
| Region of Enrollment Mexico | 712 Participants | 355 Participants | 1067 Participants |
| Region of Enrollment Peru | 710 Participants | 356 Participants | 1066 Participants |
| Sex: Female, Male Female | 706 Participants | 344 Participants | 1050 Participants |
| Sex: Female, Male Male | 716 Participants | 367 Participants | 1083 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 945 / 1,423 | 576 / 710 |
| serious Total, serious adverse events | 91 / 1,423 | 46 / 710 |
Outcome results
Primary
Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection.
High fever was defined as rectal temperature equivalent to ≥ 39.6ºC.
Time frame: Day 0 up to Day 7 post-injection
Population: The occurrence of high fever was assessed for all enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants in each group adjusted for the participant that got a vaccine assigned for the other group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Any Dose (N = 1411, 703) | 56 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 1 (N = 1408, 703) | 5 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 2 (N = 1348, 681) | 25 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 3 (N = 1328, 672) | 26 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 3 (N = 1328, 672) | 23 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Any Dose (N = 1411, 703) | 39 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 2 (N = 1348, 681) | 15 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants With High Fever Observed After Either DTaP-IPV-Hep B-PRP~T or Tritanrix Hep B/Hib™ + Placebo or Tritanrix-Hep B/Hib™ + Placebo Injection. | Post Dose 1 (N = 1408, 703) | 4 Participants |
Secondary
Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti-hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay.
Time frame: Day 30 post-dose 3
Population: Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| DTaP-IPV-Hep B-PRP~T | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | 1075 Titers |
| Tritanrix-Hep B/Hib™ + OPV | Geometric Mean Titers of Anti Hepatitis B Antibodies Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | 3376 Titers |
Secondary
Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Severe solicited reactions were defined as follows: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm; Fever ≥39.6 ºC; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, \>3 hours; Somnolence, sleeping most of the time or difficulty to wake up; Anorexia, refuses ≥3 feeds or refuses most feeds; Irritability, inconsolable.
Time frame: Day 0 up to Day 7 Post-injection
Population: Solicited injection site and systemic reactions were assessed in the enrolled and vaccinated participants, intent-to-treat (safety) population. Total numbers of participants (N) in each group adjusted for the participant that got a vaccine assigned for the other group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 1 (N=1409, 703) | 800 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 1 (N=1408, 703) | 175 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 2 (N=1348, 681) | 744 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 1 (N=1408, 703) | 11 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 2 (N=1348, 681) | 6 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 3 (N=1327, 672) | 587 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 1 (N=1406, 703) | 151 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 1 (N=1406, 703) | 8 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 3 (N=1327, 672) | 400 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 2 (N=1348, 681) | 27 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 3 (N=1328, 672) | 552 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 3 (N=1328, 672) | 30 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 1 (N=1408, 703) | 230 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 1 (N=1410, 703) | 831 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 1 (N=1409, 703) | 21 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 2 (N=1348, 681) | 721 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 2 (N=1348, 681) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 3 (N=1327, 672) | 466 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 3 (N=1327, 672) | 9 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 1 (N=1408, 703) | 635 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 1 (N=1408, 703) | 46 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 2 (N=1348, 681) | 405 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 2 (N=1348, 681) | 16 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 1 (N=1408, 703) | 11 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 2 (N=1348, 681) | 12 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 1 (N=1408, 703) | 945 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 1 (N=1408, 703) | 42 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 2 (N=1348, 681) | 799 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 2 (N=1348, 681) | 41 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 3 (N=1327, 672) | 546 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 3 (N=1327, 672) | 11 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 2 (N=1348, 681) | 105 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 3 (N=1327, 672) | 519 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 3 (N=1327, 672) | 29 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 1 (N=1408, 703) | 245 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 2 (N=1348, 681) | 427 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 3 (N=1327, 672) | 23 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 2 (N=1348, 681) | 259 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 2 (N=1348, 681) | 3 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 3 (N=1327, 672) | 3 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 1 (N=1408, 703) | 538 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 1 (N=1408, 703) | 5 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 2 (N=1348, 681) | 675 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 1 (N=1408, 703) | 10 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 2 (N=1348, 681) | 152 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 2 (N=1348, 681) | 2 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 3 (N=1328, 672) | 167 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 3 (N=1328, 672) | 17 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 3 (N=1327, 672) | 272 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 3 (N=1327, 672) | 12 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 1 (N=1408, 703) | 388 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 2 (N=1348, 681) | 327 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 3 (N=1327, 672) | 294 Participants |
| DTaP-IPV-Hep B-PRP~T | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 3 (N=1327, 672) | 18 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 1 (N=1408, 703) | 473 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 1 (N=1410, 703) | 574 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 2 (N=1348, 681) | 492 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 1 (N=1408, 703) | 193 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 3 (N=1328, 672) | 10 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 2 (N=1348, 681) | 506 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 2 (N=1348, 681) | 25 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 1 (N=1408, 703) | 15 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 2 (N=1348, 681) | 308 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 1 (N=1408, 703) | 4 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 3 (N=1327, 672) | 416 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 3 (N=1327, 672) | 340 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 3 (N=1327, 672) | 12 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 1 (N=1409, 703) | 26 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 1 (N=1406, 703) | 188 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 3 (N=1327, 672) | 17 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 2 (N=1348, 681) | 457 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 3 (N=1327, 672) | 323 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 2 (N=1348, 681) | 95 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 2 (N=1348, 681) | 16 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 3 (N=1327, 672) | 189 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pyrexia Post Dose 3 (N=1328, 672) | 445 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Pain Post Dose 3 (N=1327, 672) | 448 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pyrexia Post Dose 3 (N=1328, 672) | 23 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 1 (N=1408, 703) | 4 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 1 (N=1408, 703) | 120 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Pain Post Dose 3 (N=1327, 672) | 65 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 1 (N=1409, 703) | 564 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 3 (N=1327, 672) | 204 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Erythema Post Dose 1 (N=1408, 703) | 234 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 2 (N=1348, 681) | 481 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 2 (N=1348, 681) | 75 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 2 (N=1348, 681) | 8 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Erythema Post Dose 2 (N=1348, 681) | 16 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Crying Post Dose 3 (N=1327, 672) | 391 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 2 (N=1348, 681) | 11 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Crying Post Dose 3 (N=1327, 672) | 8 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 1 (N=1406, 703) | 24 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 1 (N=1408, 703) | 375 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Vomiting Post Dose 2 (N=1348, 681) | 4 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 1 (N=1408, 703) | 26 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Swelling Post Dose 2 (N=1348, 681) | 270 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Somnolence Post Dose 2 (N=1348, 681) | 247 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 3 (N=1327, 672) | 11 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Somnolence Post Dose 2 (N=1348, 681) | 12 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 1 (N=1408, 703) | 278 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 2 (N=1348, 681) | 11 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 1 (N=1408, 703) | 14 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Anorexia Post Dose 2 (N=1348, 681) | 195 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Vomiting Post Dose 3 (N=1328, 672) | 95 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Swelling Post Dose 3 (N=1327, 672) | 7 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Any Irritability Post Dose 1 (N=1408, 703) | 576 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Anorexia Post Dose 3 (N=1327, 672) | 17 Participants |
| Tritanrix-Hep B/Hib™ + OPV | Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination | Severe Irritability Post Dose 1 (N=1408, 703) | 47 Participants |
Secondary
Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
Anti hepatitis B (Hep B) antibodies were measured by automated enhanced chemiluminescence assay. Two Seroprotection thresholds were defined: a titer ≥ 10 mIU/mL and ≥ 100 mIU/mL, respectively.
Time frame: Day 30 post-dose 3
Population: Anti-hepatitis B antibody titers were assessed in a subset of the enrolled and vaccinated participants, intent-to-treat population.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| DTaP-IPV-Hep B-PRP~T | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | ≥ 10 mIU/mL | 100 Percentage of Participants |
| DTaP-IPV-Hep B-PRP~T | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | ≥ 100 mIU/mL | 96 Percentage of Participants |
| Tritanrix-Hep B/Hib™ + OPV | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | ≥ 10 mIU/mL | 100 Percentage of Participants |
| Tritanrix-Hep B/Hib™ + OPV | Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo | ≥ 100 mIU/mL | 99 Percentage of Participants |