Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,133 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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