Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE

Sanofi

Status and phase

Completed

Phase 4

Conditions

Poliomyelitis

Diphtheria

Tetanus

Treatments

Biological: Diphtheria, tetanus, polio and pertussis vaccination

Study type

Interventional

Funder types

Industry

Identifiers

RVX01C

Details and patient eligibility

About

PRIMARY OBJECTIVES

To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and poliovirus types 1, 2 and 3
To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses against diphtheria, tetanus, and poliovirus types 1, 2 and 3

SECONDARY OBJECTIVES

To describe other parameters of the antibody persistence against diphtheria, tetanus and poliomyelitis antigens
To describe other parameters of the immune responses to diphtheria, tetanus and poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE
To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE

Enrollment

278 patients

Sex

All

Ages

11 to 13 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Exclusion criteria

Immunization against diphtheria, tetanus, pertussis and/or poliomyelitis beyond Study F05-TdI-301
Previous clinical or bacteriological diagnosis of diphtheria, tetanus, pertussis or poliomyelitis
Known or suspected immune dysfunction
Receipt of medications / vaccination that may interfere with study assessments
Known true hypersensitivity to any of the vaccine components or to a vaccine containing the same substances
Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition
Thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection
Any medical condition that might interfere with the evaluation of the study objectives
Febrile illness