Brief Title
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.
Official Title
Large Scale Safety Study of a DTaP-IPV-Hep B-PRP~T Combined Vaccine, in Comparison to Tritanrix-Hep B/Hib™ and OPV Administered at 2, 4, and 6 Months of Age in Latin American Infants
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
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
Condition
Diphtheria
Intervention
DTaP-IPV-HB-PRP~T
Study Arms / Comparison Groups
Group 1: DTaP-IPV-Hep B-PRP-T
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
2133
Start Date
July 2006
Completion Date
February 2008
Primary Completion Date
January 2008
Eligibility Criteria
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.
Gender
All
Ages
50 Days - 71 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Monitor, ,
Location Countries
Mexico
Location Countries
Mexico
Administrative Informations
NCT ID
NCT00313911
Organization ID
A3L04
Responsible Party
Sponsor
Study Sponsor
Sanofi Pasteur, a Sanofi Company
Study Sponsor
Medical Monitor, Study Director, Sanofi Pasteur Inc.
Verification Date
April 2014