Study Comparing a DTaP-HB-PRP~T Combined Vaccine With Tritanrix HepB/Hib™, Concomitantly With OPV in Healthy Infants

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Influenza; Hepatitis B; Pertussis; Tetanus

Treatments: Biological: DTaP-HB-PRP~T combined vaccine; Biological: Oral poliomyelitis vaccine (OPV); Biological: Tritanrix-HepB/Hib™ vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00348881

AL201

Details and patient eligibility

About

This is a study to compare the safety and immune response of a pentavalent DTaP-HB-PRP~T combined vaccine with Tritanrix-HepB/Hib™, when both are given concomitantly with OPV at 6, 10, and 14 weeks of age.

Enrollment: 2,133 patients

Sex: All

Ages: 42 to 50 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

At Screening:

• 0 to 3 day old infants
• Born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg
• Apgar score ≥ 7 at three minutes after birth
• Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)

At Inclusion:

• Six weeks of age
• Received a dose of Hepatitis B (HB) in the first three days of life
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria

At Screening:

• Illness at a stage that could interfere with trial conduct or completion
• Any vaccination before HB vaccination (except bacille Calmette-Guérin [BCG] given at birth)
• Vaccination planned in the 4 to 6 weeks following the first trial vaccination (except BCG if not given at birth)
• Acute illness on the day of screening.

At Screening and at Inclusion:

• Blood or blood-derived products received since birth
• Planned participation in another clinical trial during the present trial period
• Mother known as seropositive to Human immunodeficiency virus (HIV) or Hepatitis C, or as carrying the HB surface antigen (HBsAg)
• Known thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination
• Known hypersensitivity to any component of any vaccine to be used in the trial (including neomycin and polymixin B)

At Inclusion:

• Non-trial vaccine administered since birth, except Bacille Calmette-Guérin (BCG)
• Participation in another clinical trial before the first trial vaccination
• 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 the trial vaccine or a vaccine containing the same substances
• Chronic illness at a stage that could interfere with trial conduct or completion
• Vaccination other than with the study vaccines planned in the 12 weeks following inclusion
• Documented history of pertussis, tetanus, diphtheria, polio, H. influenza type b, or HB infection (confirmed clinically, serologically, or microbiologically)
• 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: Quadruple Blind

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2,133 participants in 2 patient groups

Group 1: DTaP-Hep B-PRP-T + OPV vaccine

Experimental group

Description:

Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Treatment:

Biological: DTaP-HB-PRP~T combined vaccine

Biological: Oral poliomyelitis vaccine (OPV)

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

Active Comparator group

Description:

Participants received 3 doses of the Tritanrix-HepB/Hib™ concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.

Treatment:

Biological: Oral poliomyelitis vaccine (OPV)

Biological: Tritanrix-HepB/Hib™ vaccine