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

Sanofi Pasteur, a Sanofi Company278 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

278

Conditions

Diphtheria Tetanus Poliomyelitis

Interventions

Eligibility

Sex: ALLMin age: 11 YearsMax age: 13 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301 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

Locations (45)

SPMSD Investigational Site 120

Angers, France

SPMSD Investigational Site 103

Arras, France

SPMSD Investigational Site 155

Asnières, France

SPMSD Investigational Site 125

Bersée, France

SPMSD Investigational Site 121

Besançon, France

SPMSD Investigational Site 141