Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™

Sanofi

Status and phase: Completed; Phase 3

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

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00534833

AL205

Details and patient eligibility

About

The present trial is a follow-up of AL203 study (NCT00343889).

Primary Objectives:

To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with Oral Polio Vaccine [OPV]).

Secondary Objective:

To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.

Full description

Study participants will receive a booster vaccination of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ either concomitantly with Oral Polio Vaccine (OPV) following the completion of a three dose primary series with DTaP-Hep B-PRP-T combined vaccine or Tritanrix HepB/Hib™, both given concomitantly with OPV. Participants will receive a booster dose of the vaccine they had received in the primary series, and a concomitant dose of OPV Study AL203 (NCT00343889).

Enrollment: 362 patients

Sex: All

Ages: 15 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
• Participated in the AL203 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age
• Informed consent form signed by one parent or legal representative if appropriate (independent witness 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 trial vaccination
• Planned participation in another clinical trial during the present trial period
• Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
• Known 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 in the last 3 months
• Any vaccination in the 4 weeks preceding the trial vaccination
• Vaccination planned in the 4 weeks following the trial vaccination
• Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
• History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
• Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B, or poliovirus 3 types antigen since the end of the primary series
• Thrombocytopenia or a bleeding disorder contraindicating intramuscular (IM) vaccination
• Serious adverse event related to any vaccination in the AL203 study.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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362 participants in 2 patient groups

Group 1

Experimental group

Description:

DTaP-Hep B-PRP-T + OPV vaccine group

Treatment:

Biological: DTaP-HB-PRP~T vaccine

Biological: Oral Polio Vaccine

Group 2

Active Comparator group

Description:

Tritanrix-HepB/Hib™ + OPV vaccine group

Treatment:

Biological: Oral Polio Vaccine

Biological: Tritanrix-HepB/Hib™