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

Phase 4

Completed

• Conditions: Diphtheria; Tetanus; Poliomyelitis

• Registration Number: NCT01546909
• Lead Sponsor: Sanofi Pasteur, a Sanofi Company

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-02
• Study First Submitted QC: 2012-03-02
• Study First Posted: 2012-03-07
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 278

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proportion of subjects with an anti-diphtheria concentration ≥0.01 IU/mL	Pre-booster dose (Day 0)
Proportion of subjects with an anti-tetanus concentration ≥0.01 IU/mL	Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 1 titer ≥ 8 (1/dilution)	Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 2 titer ≥ 8 (1/dilution)	Pre-booster dose (Day 0)
Proportion of subjects with an anti-polio type 3 titer ≥ 8 (1/dilution)	Pre-booster dose (Day 0)
Proportion of subjects with an anti-diphtheria concentration ≥0.1 IU/mL	1 month post-booster dose
Proportion of subjects with an anti-tetanus concentration ≥0.1 IU/mL	1 month post-booster dose
Proportion of subjects with an anti-polio type 1 titer ≥8 (1/dilution)	1 month post-booster dose
Proportion of subjects with an anti-polio type 2 titer ≥8 (1/dilution)	1 month post-booster dose
Proportion of subjects with an anti-polio type 3 titer ≥8 (1/dilution)	1 month post-booster dose

Secondary Outcome Measures

Name	Time	Method
Geometric mean titer for diphtheria	Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for tetanus	Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 1	Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 2	Pre-booster (Day 0) and 1 month post-booster dose
Geometric mean titer for polio type 3	Pre-booster (Day 0) and 1 month post-booster dose
Solicited injection site and solicited systemic reactions	From Day 0 to Day 7 post vaccination
Unsolicited injection site reactions and unsolicited systemic adverse events	From Day 0 to Day 28 days post vaccination
Serious adverse events	From signature of informed consent up to last study visit of the subject

Trial Locations

Locations (45)

SPMSD Investigational Site 120; 🇫🇷 Angers, France

SPMSD Investigational Site 103; 🇫🇷 Arras, France

SPMSD Investigational Site 155; 🇫🇷 Asnieres, France

SPMSD Investigational Site 125; 🇫🇷 Bersee, France

SPMSD Investigational Site 121; 🇫🇷 Besancon, France

SPMSD Investigational Site 141; 🇫🇷 Besancon, France

SPMSD Investigational Site 124; 🇫🇷 Blois, France

SPMSD Investigational Site 161; 🇫🇷 Blois, France

SPMSD Investigational Site 194; 🇫🇷 Boulogne Billancourt, France

SPMSD Investigational Site 148; 🇫🇷 Brest, France

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