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

September 8, 2017 updated by: Sanofi Pasteur, a Sanofi Company

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

278

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • SPMSD Investigational Site 120
      • Arras, France
        • SPMSD Investigational Site 103
      • Asnieres, France
        • SPMSD Investigational Site 155
      • Bersee, France
        • SPMSD Investigational Site 125
      • Besancon, France
        • SPMSD Investigational Site 121
      • Besancon, France
        • SPMSD Investigational Site 141
      • Blois, France
        • SPMSD Investigational Site 124
      • Blois, France
        • SPMSD Investigational Site 161
      • Boulogne Billancourt, France
        • SPMSD Investigational Site 194
      • Brest, France
        • SPMSD Investigational Site 148
      • Caen, France
        • SPMSD Investigational Site 117
      • Caen, France
        • SPMSD Investigational Site 147
      • Chalons En Champagne, France
        • SPMSD Investigational Site 135
      • Champdeniers, France
        • SPMSD Investigational Site 163
      • Chigny Les Roses, France
        • SPMSD Investigational Site 145
      • Cholet, France
        • SPMSD Investigational Site 157
      • Clamart, France
        • SPMSD Investigational Site 101
      • Collombey Les Belles, France
        • SPMSD Investigational Site 160
      • Collombey Les Belles, France
        • SPMSD Investigational Site 162
      • DAX, France
        • SPMSD Investigational Site 139
      • Draguignan, France
        • SPMSD Investigational Site 193
      • Essey Les Nancy, France
        • SPMSD Investigational Site 106
      • Essey Les Nancy, France
        • SPMSD Investigational Site 123
      • Essey Les Nancy, France
        • SPMSD Investigational Site 164
      • Floirac, France
        • SPMSD Investigational Site 136
      • Frouard, France
        • SPMSD Investigational Site 114
      • Haguenau, France
        • SPMSD Investigational Site 150
      • Illkirch Graffenstaden, France
        • SPMSD Investigational Site 113
      • Le Havre, France
        • SPMSD Investigational Site 197
      • Le Havre, France
        • SPMSD Investigational Site 198
      • Lingolsheim, France
        • SPMSD Investigational Site 107
      • Louverne, France
        • SPMSD Investigational Site 115
      • Manduel, France
        • SPMSD Investigational Site 140
      • Maromme, France
        • SPMSD Investigational Site 116
      • Marseille, France
        • SPMSD Investigational Site 153
      • Montpellier, France
        • SPMSD Investigational Site 134
      • Nogent Sur Marne, France
        • SPMSD Investigational Site 129
      • Ostwald, France
        • SPMSD Investigational Site 133
      • Poitiers, France
        • SPMSD Investigational Site 128
      • Pont A Mousson, France
        • SPMSD Investigational Site 130
      • Quimper, France
        • SPMSD Investigational Site 151
      • Rouen, France
        • SPMSD Investigational Site 102
      • Rouen, France
        • SPMSD Investigational Site 110
      • Rouen, France
        • SPMSD Investigational Site 199
      • Saint Ouen, France
        • SPMSD Investigational Site 152

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TETRAVAC-ACELLULAIRE
Biological: Diphtheria, tetanus, polio and pertussis vaccination
1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi Pasteur, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

March 2, 2012

First Submitted That Met QC Criteria

March 2, 2012

First Posted (Estimate)

March 7, 2012

Study Record Updates

Last Update Posted (Actual)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 8, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RVX01C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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