Clinical trial NCT00313911: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Haemophilus Influenzae Type b
Hepatitis B
Keywords: Diphtheria
Tetanus
Pertussis
Recombinant Hepatitis B
Poliomyelitis
Haemophilus influenzae type b
Tetanus protein
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-04-12
Enrollment: 2133
Sex: ALL
Minimum age (years): 50
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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.
timeFrame: Day 0 up to Day 7 post-injection
Secondary outcomes:
measure: 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
timeFrame: Day 30 post-dose 3
measure: Percentage of Participants Reaching Seroprotection Threshold Following Vaccination With Either DTaP-IPV-Hep B-PRP~T Vaccine + Placebo or Tritanrix-Hep B/Hib™ + Placebo
timeFrame: Day 30 post-dose 3
measure: Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Each Vaccination
timeFrame: Day 0 up to Day 7 Post-injection
Other outcomes:
Locations:
city: Mexico DF
country: Mexico
city: Lima
country: Peru
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Macias M, Lanata CF, Zambrano B, Gil AI, Amemiya I, Mispireta M, Ecker L, Santos-Lima E. Safety and immunogenicity of an investigational fully liquid hexavalent DTaP-IPV-Hep B-PRP-T vaccine at two, four and six months of age compared with licensed vaccines in Latin America. Pediatr Infect Dis J. 2012 Aug;31(8):e126-32. doi: 10.1097/INF.0b013e318258400d.