REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

Sanofi

Status and phase: Completed; Phase 3

Conditions: Poliomyelitis; Diphtheria; Tetanus

Treatments: Biological: REVAXIS®; Biological: DT-Polio®

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447525

F05-TdI-301

Details and patient eligibility

About

Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

• Additional immunogenicity assessments.
• To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

Enrollment: 760 patients

Sex: All

Ages: 6 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy child without chronic severe disease of either gender,
2. 6 year-old child on vaccination day,
3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
4. Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion criteria

1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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760 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: REVAXIS®

2

Active Comparator group

Treatment:

Biological: DT-Polio®