Antibody persistence in 11 to 13-year-old children previously vaccinated at 6 years old with either REVAXIS or DT Polio, and immune response to a booster dose of TETRAVAC-ACELLULAIRE - Antibody persistence to REVAXIS or DT Polio and Immune response to TETRAVAC-ACELLULAIRE

Phase 1

• Conditions: Persistence of antibody against diphtheria, tetanus and poliomyelitis in 11 to 13-year-old children who received either REVAXIS or DT Polio at 6 year of age, and immune response to TETRAVAC-ACELLULAIRE; MedDRA version: 14.0Level: PTClassification code 10054175Term: Polio immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10054129Term: Diphtheria immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10069577Term: Pertussis immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 14.0Level: PTClassification code 10054131Term: Tetanus immunisationSystem Organ Class: 10042613 - Surgical and medical procedures; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2011-004458-25-FR
• Lead Sponsor: Sanofi Pasteur MSD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-11
• Last Update Posted: 2 October 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 476

Inclusion Criteria

Healthy child of either gender 11 to 13 years of age and vaccinated in Study F05-TdI-301 with either REVAXIS or DT Polio at approximately 6 years of age,
Consent form signed by both parents, or by the legal guardian, properly informed about the study,
Assent form signed by the child,
Affiliated to a health social security system.

Are the trial subjects under 18? yes
Number of subjects for this age range: 476
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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,
Immune impairment or humoral/cellular deficiency, neoplasic disease or depressed immunity,
Receipt of any chemotherapy agents to treat cancer received within 6 months prior to vaccination
Receipt of serum immune globulin or any other blood-derived product within 3 months prior to vaccination
Receipt of immunomodulator therapy within 6 weeks prior to vaccination
Receipt of daily -or on alternate days- systemic corticosteroids at a dose =20 mg/day of prednisone (or equivalent) for =14 days within 4 weeks prior to vaccination
Receipt of any live non-study vaccine within 28 days or of any inactivated non-study vaccine within 14 days prior to vaccination or with a vaccination planned during the whole study period,
Known true hypersensitivity to at least one of the components of TETRAVAC-ACELLULAIRE, to glutaraldehyde, neomycin, streptomycin and polymyxin B, to pertussis, vaccines (acellular or whole cell pertussis), or to a vaccine containing the same substances,
Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
Any medical condition that, in the opinion of the investigator, could interfere with the evaluation of the study objectives,
Child who participated in another clinical study within 28 days prior to vaccination or would participate in another clinical study during the whole study period,
Acute severe febrile illness and/or body temperature >=38.0°C within 72 hours prior to vaccination.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified