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.

NCT ID: NCT00313911

Last Updated: 2014-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2133 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2008-02-29

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.

Conditions

Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Hepatitis B

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Group 1: DTaP-IPV-Hep B-PRP-T

Group Type: EXPERIMENTAL

DTaP-IPV-HB-PRP~T

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular (IM)

Group 2: Tritanrix-Hep B/Hib™+OPV

Group Type: ACTIVE_COMPARATOR

Tritanrix-HepB/Hib

Intervention Type: BIOLOGICAL

0.5 mL, Intramuscular

Interventions

DTaP-IPV-HB-PRP~T

0.5 mL, Intramuscular (IM)

Intervention Type: BIOLOGICAL

Tritanrix-HepB/Hib

0.5 mL, Intramuscular

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 50 Days
• Maximum Eligible Age: 71 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sanofi Pasteur, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Sanofi Pasteur Inc.

Locations

Mexico City, , Mexico

Lima, , Peru

Countries

Mexico; Peru

References

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.

Reference Type: RESULT

PMID: 22531237 (View on PubMed)

Related Links

http://www.sanofipasteur.com

Related Info

Other Identifiers

A3L04

Identifier Type: -

Identifier Source: org_study_id