REVAXIS® Versus DT Polio® as a Second Booster in 6 Year-old Children

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

Comparison of the Immunogenicity and Safety of a Combined Adsorbed Low Dose Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (REVAXIS®) With a Combined Diphtheria, Tetanus and Inactivated Poliomyelitis Vaccine (DT Polio®) When Given as a Booster Dose at 6 Years of Age

Primary objective:

To demonstrate the non inferiority between REVAXIS® and DT Polio® when given as a second booster to healthy 6 year-old children .

Secondary objectives:

  • Additional immunogenicity assessments.
  • To describe the safety profile of a single dose of REVAXIS® or DT-Polio®

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

760

Phase

  • Phase 3

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
      • Albertville, France, 95880
      • Albi, France, 81000
      • Angers, France, 49100
      • Annecy, France, 74000
      • Anzin, France, 59410
      • Arras, France, 62000
      • Asnieres, France, 92600
      • Avion, France, 62210
      • Bassens, France, 33530
      • Bersee, France, 59235
      • Besancon, France, 25000
      • Blois, France, 41000
      • Boulogne, France, 92100
      • Brest, France, 29200
      • Broglie, France, 27270
      • Caen, France, 14000
      • Chalon-en-champagne, France, 51000
      • Champdeniers, France, 79220
      • Chigny Les Roses, France, 51500
      • Cholet, France, 49300
      • Claix, France, 38640
      • Clamart, France, 92141
      • Collombey Les Belles, France, 54170
      • Draguignan, France, 83300
      • Enghien-les-bains, France, 95880
      • Floirac, France, 33270
      • Frouard, France, 54390
      • Haguenau, France, 67500
      • Illkirch-graffenstaden, France, 67400
      • Issy Les Moulineaux, France, 92130
      • La Neuville Roy, France, 60190
      • Laon, France, 02000
      • Le Havre, France, 76600
      • Les Pieux, France, 50340
      • Louverne, France, 53950
      • Louvigne de Bais, France, 35680
      • Manduel, France, 30129
      • Marcq-en-barouel, France, 59700
      • Maromme, France, 76150
      • Marseille, France, 13004
      • Miniac Morvan, France, 35540
      • Montpellier, France, 34080
      • Montsang/orge, France, 91390
      • Morangis, France, 91420
      • Nancy, France, 54000
      • Nantes, France, 44300
      • Nogent Sur Marne, France, 94130
      • Ostwald, France, 67540
      • Paris, France, 75013
      • Paris, France, 75019
      • Plouzane, France, 29280
      • Poitiers, France, 86000
      • Pont A Mousson, France, 54700
      • Quimper, France, 29000
      • Rouen, France, 76000
      • Rouen, France, 76100
      • Saint Sebastien Sur Loir, France, 44230
      • Saint-ouen, France, 93400
      • Saint-raphael, France, 83700
      • Sanary Mer, France, 83110
      • Sevres, France, 92310
      • Strasbourg, France, 67000
      • Toulouse, France, 31000
      • Villemomble, France, 93250

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

6 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy child without chronic severe disease of either gender,
  2. 6 year-old child on vaccination day,
  3. Child previously vaccinated with three doses of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination within the first 6 months of life and a booster dose of a diphtheria, tetanus and poliomyelitis containing vaccine given alone or in combination at 16 - 18 months of life (±2 months),
  4. Consent form signed by both parents, or by the legal representative, properly informed about the study.

Exclusion Criteria:

  1. Child who had received less or more than 4 doses of a diphtheria, tetanus and/or poliomyelitis containing vaccine,
  2. Previous clinical or bacteriological diagnosis of diphtheria, tetanus or poliomyelitis,
  3. Child who had received any vaccine in the previous 30 days or with a vaccination scheduled during the course of the study,
  4. Child who present with immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity,
  5. Child who had received within the previous 150 days or who will receive during the course of the study, any immunoglobulins or blood derived products,
  6. Child with true hypersensitivity to at least one of the components of a study vaccine or to streptomycin, neomycin or polymixin B,
  7. Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
  8. Child who had presented severe hypersensitivity following an earlier immunization against diphtheria and/or tetanus,
  9. Known history of thrombocytopenia or any coagulation disorder that would contraindicate intramuscular injection,
  10. Acute severe febrile illness and/or oral temperature ≥37.5°C at the time of vaccination

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: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 2
Biological: DT-Polio®
EXPERIMENTAL: 1
Biological: REVAXIS®

Collaborators and Investigators

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

Sponsor

Sanofi Pasteur, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2007

Primary Completion (ACTUAL)

January 1, 2008

Study Completion (ACTUAL)

January 1, 2008

Study Registration Dates

First Submitted

March 12, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (ESTIMATE)

March 14, 2007

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F05-TdI-301

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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