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

NCT01546909 | Completed Phase 4

• 1 other identifier: RVX01C
• Study Type: interventional
• Target: 278
• Locations: 1 country
• Sites: 45

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

Conditions

Diphtheria; Tetanus; Poliomyelitis

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (8)

• 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

Study Arms (1)

TETRAVAC-ACELLULAIRE

EXPERIMENTAL

Biological: Diphtheria, tetanus, polio and pertussis vaccination

Interventions

Diphtheria, tetanus, polio and pertussis vaccination BIOLOGICAL

1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

TETRAVAC-ACELLULAIRE

Eligibility Criteria

• Age: 11 Years - 13 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy child 11 to 13 years of age previously vaccinated in Study F05-TdI-301

You may not qualify if:

• 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

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (45)

SPMSD Investigational Site 120

Angers, France

Location

SPMSD Investigational Site 103

Arras, France

Location

SPMSD Investigational Site 155

Asnières, France

Location

SPMSD Investigational Site 125

Bersée, France

Location

SPMSD Investigational Site 121

Besançon, France

Location

SPMSD Investigational Site 141

Besançon, France

Location

SPMSD Investigational Site 124

Blois, France

Location

SPMSD Investigational Site 161

Blois, France

Location

SPMSD Investigational Site 194

Boulogne-Billancourt, France

Location

SPMSD Investigational Site 148

Brest, France

Location

SPMSD Investigational Site 117

Caen, France

Location

SPMSD Investigational Site 147

Caen, France

Location

SPMSD Investigational Site 163

Champdeniers, France

Location

SPMSD Investigational Site 135

Châlons-en-Champagne, France

Location

SPMSD Investigational Site 145

Chigny-les-Roses, France

Location

SPMSD Investigational Site 157

Cholet, France

Location

SPMSD Investigational Site 101

Clamart, France

Location

SPMSD Investigational Site 160

Collombey Les Belles, France

Location

SPMSD Investigational Site 162

Collombey Les Belles, France

Location

SPMSD Investigational Site 139

Dax, France

Location

SPMSD Investigational Site 193

Draguignan, France

Location

SPMSD Investigational Site 106

Essey-lès-Nancy, France

Location

SPMSD Investigational Site 123

Essey-lès-Nancy, France

Location

SPMSD Investigational Site 164

Essey-lès-Nancy, France

Location

SPMSD Investigational Site 136

Floirac, France

Location

SPMSD Investigational Site 114

Frouard, France

Location

SPMSD Investigational Site 150

Haguenau, France

Location

SPMSD Investigational Site 113

Illkirch-Graffenstaden, France

Location

SPMSD Investigational Site 197

Le Havre, France

Location

SPMSD Investigational Site 198

Le Havre, France

Location

SPMSD Investigational Site 107

Lingolsheim, France

Location

SPMSD Investigational Site 115

Louverné, France

Location

SPMSD Investigational Site 140

Manduel, France

Location

SPMSD Investigational Site 116

Maromme, France

Location

SPMSD Investigational Site 153

Marseille, France

Location

SPMSD Investigational Site 134

Montpellier, France

Location

SPMSD Investigational Site 129

Nogent-sur-Marne, France

Location

SPMSD Investigational Site 133

Ostwald, France

Location

SPMSD Investigational Site 128

Poitiers, France

Location

SPMSD Investigational Site 130

Pont-à-Mousson, France

Location

SPMSD Investigational Site 151

Quimper, France

Location

SPMSD Investigational Site 102

Rouen, France

Location

SPMSD Investigational Site 110

Rouen, France

Location

SPMSD Investigational Site 199

Rouen, France

Location

SPMSD Investigational Site 152

Saint-Ouen, France

Location

MeSH Terms

Conditions

Diphtheria; Tetanus; Poliomyelitis

Interventions

Tetanus Toxoid

Condition Hierarchy (Ancestors)

Corynebacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Clostridium Infections; Myelitis; Central Nervous System Infections; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Virus Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Neuroinflammatory Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Toxoids; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Medical Director

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 7, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 11, 2017

Record last verified: 2017-09

Locations

FR (45)