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DiphtheriaPhase 3NCT00447525

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

A Phase 3 study testing REVAXIS® and DT-Polio® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 64 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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® Read more about this study

Who is it for?
Ages 6 to 6 yearsHealthy volunteers can take part
Conditions the study is for
Diphtheria, Tetanus, Poliomyelitis
What is being tested?
REVAXIS® and DT-Polio®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
760 participants
Where
64 sitesFrance
Study dates
Feb 2007to Jan 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 6 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy child without chronic severe disease of either gender,
  • 6 year-old child on vaccination day,
  • 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),
  • Consent form signed by both parents, or by the legal representative, properly informed about the study.

Who cannot join

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

Trial locations and contacts

64 sites in 1 country.

64 sites in 1 country

France64 sites

  • Study site

    Albertville, 95880

  • Study site

    Albi, 81000

  • Study site

    Angers, 49100

  • Study site

    Annecy, 74000

  • Study site

    Anzin, 59410

  • Study site

    Arras, 62000

  • Study site

    Asnières, 92600

  • Study site

    Avion, 62210

  • Study site

    Bassens, 33530

  • Study site

    Bersée, 59235

  • Study site

    Besançon, 25000

  • Study site

    Blois, 41000

  • Study site

    Boulogne, 92100

  • Study site

    Brest, 29200

  • Study site

    Broglie, 27270

  • Study site

    Caen, 14000

  • Study site

    Chalon-en-champagne, 51000

  • Study site

    Champdeniers, 79220

  • Study site

    Chigny-les-Roses, 51500

  • Study site

    Cholet, 49300

  • Study site

    Claix, 38640

  • Study site

    Clamart, 92141

  • Study site

    Collombey Les Belles, 54170

  • Study site

    Draguignan, 83300

  • Study site

    Enghien-les-Bains, 95880

  • Study site

    Floirac, 33270

  • Study site

    Frouard, 54390

  • Study site

    Haguenau, 67500

  • Study site

    Illkirch-Graffenstaden, 67400

  • Study site

    Issy-les-Moulineaux, 92130

  • Study site

    La Neuville-Roy, 60190

  • Study site

    Laon, 02000

  • Study site

    Le Havre, 76600

  • Study site

    Les Pieux, 50340

  • Study site

    Louverné, 53950

  • Study site

    Louvigné-de-Bais, 35680

  • Study site

    Manduel, 30129

  • Study site

    Marcq-en-barouel, 59700

  • Study site

    Maromme, 76150

  • Study site

    Marseille, 13004

  • Study site

    Miniac-Morvan, 35540

  • Study site

    Montpellier, 34080

  • Study site

    Montsang/orge, 91390

  • Study site

    Morangis, 91420

  • Study site

    Nancy, 54000

  • Study site

    Nantes, 44300

  • Study site

    Nogent-sur-Marne, 94130

  • Study site

    Ostwald, 67540

  • Study site

    Paris, 75013

  • Study site

    Paris, 75019

  • Study site

    Plouzané, 29280

  • Study site

    Poitiers, 86000

  • Study site

    Pont-à-Mousson, 54700

  • Study site

    Quimper, 29000

  • Study site

    Rouen, 76000

  • Study site

    Rouen, 76100

  • Study site

    Saint Sebastien Sur Loir, 44230

  • Study site

    Saint-Ouen, 93400

  • Study site

    Saint-Raphaël, 83700

  • Study site

    Sanary Mer, 83110

  • Study site

    Sèvres, 92310

  • Study site

    Strasbourg, 67000

  • Study site

    Toulouse, 31000

  • Study site

    Villemomble, 93250

Other trials in France

About this study

Official title: 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®
Being tested
REVAXIS®, DT-Polio®
Keywords
Prevention of : Diphtheria, Tetanus and Poliomyelitis
Medical subject headings
Diphtheria, Tetanus, Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REVAXIS®Biological

  • DT-Polio®Biological

Study groups in NCT00447525
Study groupRoleWhat they receive
1ExperimentalNot described
Receives: Biological: REVAXIS®
2Active comparatorNot described
Receives: Biological: DT-Polio®

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2007 (estimated)
  2. Study startFeb 2007
  3. Primary completionJan 2008
  4. Study completionJan 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00447525
Sponsor's protocol ID
F05-TdI-301
Status last verified
Sep 2017
First submitted
12 Mar 2007
Last updated
11 Sep 2017
Results posted
No

Publications

  • Gajdos V, Soubeyrand B, Vidor E, Richard P, Boyer J, Sadorge C, Fiquet A. Immunogenicity and safety of combined adsorbed low-dose diphtheria, tetanus and inactivated poliovirus vaccine (REVAXIS ((R))) versus combined diphtheria, tetanus and inactivated poliovirus vaccine (DT Polio ((R))) given as a booster dose at 6 years of age. Hum Vaccin. 2011 May;7(5):549-56. doi: 10.4161/hv.7.5.14982. Epub 2011 May 1.

    PubMed 21441781

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing REVAXIS® and DT-Polio® in people with Diphtheria and Tetanus, run by Sanofi Pasteur, a Sanofi Company at 64 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00447525, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2017.

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