Study of Immunogenicity and Safety of a Booster Dose of DTaP-IPV-HB-PRP~T Combined Vaccine in Healthy Turkish Infants

Sanofi

Status and phase: Completed; Phase 3

Conditions: Diphtheria; Polio; Hepatitis B; Pertussis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00619502

A3L22

Details and patient eligibility

About

This is a follow-up of Study A3L10 (NCT00315055)

Immunogenicity

• To describe the antibody persistence following a primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B®.
• To describe the immunogenicity of a booster dose of DTaP-IPV-HB-PRP~T.

Safety

• To describe the safety profile after a booster dose of DTaP-IPV-HB-PRP~T.

Enrollment: 254 patients

Sex: All

Ages: 15 to 18 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Toddler previously included in Study A3L10 who completed the three-dose primary series vaccination of either DTaP-IPV-HB-PRP~T or PENTAXIM™ and ENGERIX B® at 2, 3 and 4 months of age.
• Toddler of 15 to 18 months of age (range: 456 to 578 days of age inclusive).
• 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 booster 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 in the last 3 months.
• Any vaccination in the 4 weeks preceding the booster vaccination.
• Any vaccination planned until second Visit.
• History of documented pertussis, tetanus, diphtheria, polio, Haemophilus influenzae type b or hepatitis B infection(s) (confirmed either clinically, serologically or microbiologically).
• Previous booster vaccination against pertussis, tetanus, diphtheria, polio or Haemophilus influenzae type b, and hepatitis B infection(s).
• Coagulopathy, thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination.
• Any vaccine-related serious adverse event that occurred following the three-dose primary series administration of the investigational vaccine or of the reference vaccine in Study A3L10 (NCT00315055).
• Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion.
• Known contraindication to further vaccination with a pertussis vaccine, i.e.: Encephalopathy; temperature > 40.0°C within 48 hours following a vaccine injection, not due to another identifiable cause during the primary series; Inconsolable crying that occurred for > 3 hours within 48 hours following vaccine injection during the primary series; Hypotonic hyporesponsive episode within 48 hours following vaccine injection during the primary series; Seizures with or without fever within 3 days following vaccine injection.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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254 participants in 2 patient groups

DTaP-IPV-Hep B-PRP~T Vaccine Group

Experimental group

Description:

Participants received a primary series of 3 vaccinations with DTaP-IPV-Hep B-PRP\~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-HepB-PRP\~T at 15 to 18 months of age in the present study

Treatment:

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

Pentaxim™ + Engerix B™ Vaccines Group

Active Comparator group

Description:

Participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they will receive a booster dose of DTaP-IPV-Hep B-PRP\~T at 15 to 18 months of age in the present study.

Treatment:

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