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

Brief Title

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

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

Brief 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®
    


Study Phase

Phase 3

Study Type

Interventional




Condition

Diphtheria

Intervention

REVAXIS®

Study Arms / Comparison Groups

 1
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

760

Start Date

February 2007

Completion Date

January 2008

Primary Completion Date

January 2008

Eligibility Criteria

        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
      

Gender

All

Ages

6 Years - 6 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Medical Director, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT00447525

Organization ID

F05-TdI-301


Responsible Party

Sponsor

Study Sponsor

Sanofi Pasteur, a Sanofi Company


Study Sponsor

Medical Director, Study Director, Sanofi Pasteur, a Sanofi Company


Verification Date

September 2017