Comparison of DTaP-HB-PRP~T Combined Vaccine to Tritanrix-HepB/Hib™, Both Given Concomitantly With Oral Polio Vaccine

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Haemophilus Infections; Hepatitis B; Pertussis; Tetanus

Treatments: Biological: Oral Polio Vaccine; Biological: DTaP-HB-PRP~T vaccine + OPV; Biological: Tritanrix-HepB/Hib™ + OPV vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00343889

AL203

Details and patient eligibility

About

The purpose of this study is to support the registration of the pentavalent DTaP-HB-PRP~T vaccine in countries that follow the World Health Organization-Expanded Program of Immunization (WHO-EPI) schedule.

The primary objective is:

• To demonstrate that the pentavalent DTaP-HB-PRP~T combined vaccine does not induce a lower immune response than Tritanrix-HepB/Hib™ in terms of the seroprotection rate to hepatitis B (HB) one month after a 3-dose primary series at 6, 10, and 14 weeks of age.

The secondary objectives are:

• To describe in each group the immunogenicity parameters one month after the 3-dose primary series at 6, 10, and 14 weeks of age; and
• To evaluate the overall safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial.

Enrollment: 379 patients

Sex: All

Ages: 42 to 50 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Six week old infants (42 to 50 days old) on the day of inclusion; of either gender.
• Mother tested as seronegative for hepatitis B surface antigen (HBsAg) between 28 weeks of pregnancy and up to 4 days after delivery
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Informed consent form signed by one parent or other legal representative if appropriate (independent witness is mandatory if parent is illiterate)
• 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.
• Chronic illness at a stage that could interfere with the conduct or completion of the trial
• Blood or blood-derived products received since birth
• HB vaccination since birth
• Any vaccination in the four weeks preceding the first trial vaccination
• Any planned vaccination (except trial vaccines and bacillus Calmette-Guerin (BCG) during the trial
• Documented history of pertussis, tetanus (T), diphtheria (D), polio, or Haemophilus influenzae type b (Hib) infection(s) (confirmed either clinically, serologically, or microbiologically)
• Known personal or maternal history of HIV, HBsAg or hepatitis C seropositivity
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
• History of seizures
• Febrile (rectal temperature ≥ 38.0°C) or acute illness on the day of inclusion.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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379 participants in 2 patient groups

Group 1: DTaP-Hep B-PRP-T + Oral Polio Vaccine (OPV) vaccine

Experimental group

Description:

Participants received 3 doses of the DTaP-Hep B-PRP\~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.

Treatment:

Biological: Oral Polio Vaccine

Biological: DTaP-HB-PRP~T vaccine + OPV

Group 2: Tritanrix-HepB/Hib™ + OPV vaccine

Active Comparator group

Description:

Participants received 3 doses of Tritanrix-Hep B/Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10, and 14 weeks of age.

Treatment:

Biological: Oral Polio Vaccine

Biological: Tritanrix-HepB/Hib™ + OPV vaccine