Immunogenicity of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared With PENTAXIM™ and ENGERIX B® at 2-3-4 Months Schedule

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Polio; Pertussis; Hepatitis B

Treatments: Biological: DTaP-IPV-HB-PRP~T vaccine; Biological: Hepatitis B vaccine; Biological: DTaP-IPV//PRP~T combined

Study type: Interventional

Funder types: Industry

Identifiers

NCT00315055

A3L10

Details and patient eligibility

About

To demonstrate that the immune response to hepatitis B antigen of the DTaP-IPV-Hep B-PRP~T is non-inferior to that of the association of PENTAXIM™ and ENGERIX B® one month after a three dose (2-3-4 month) primary series.

Immunogenicity

• To assess pre- and post-primary series
• To assess pre- and post-booster series.

Enrollment: 310 patients

Sex: All

Ages: 50 to 71 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Two-month old infants of either gender 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 the parent(s) or other legal representative(s) and an institution official other than an investigator
• Able to attend all scheduled visits and to comply with all trial procedures.

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 corticosteroid therapy
• Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to 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 (except BCG) in the 4 weeks preceding the first trial vaccination
• Vaccination planned in the 4 weeks following trial vaccination
• History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically)
• Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity
• Previous vaccination against pertussis, tetanus, diphtheria, polio or Hib, and HB infection(s)
• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
• History of seizures
• Febrile (axillary temperature 37.4°C [rectal equivalent temperature >=38.0°C]) or acute illness on the day of inclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

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

Experimental group

Description:

Participants will receive 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP\~T); One dose each at 2, 3, and 4 months of age.

Treatment:

Biological: DTaP-IPV-HB-PRP~T vaccine

Group 2: PENTAXIM™ and ENGERIX B® PEDIATRIC

Active Comparator group

Description:

Participants will receive 3 vaccinations with DTaP-IPV-PRP\~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines. One dose each at 2, 3, and 4 months of age.

Treatment:

Biological: DTaP-IPV//PRP~T combined

Biological: Hepatitis B vaccine