NCT01546909

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 278 (actual)
• Sponsor: Sanofi Pasteur, a Sanofi Company · Industry
• Sex: All
• Age: 11 Years – 13 Years
• Healthy volunteers: Accepted

Summary

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

Conditions

• Diphtheria
• Tetanus
• Poliomyelitis

Interventions

Type	Name	Description
BIOLOGICAL	Diphtheria, tetanus, polio and pertussis vaccination	1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

Timeline

• Start date: 2012-02-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2012-03-07
• Last updated: 2017-09-11

Locations

45 sites across 1 country: France