Brief Title
Safety and Immunogenicity Study of Concomitant Versus Non Concomitant Administration of a Diphtheria, Tetanus, Pertussis and Poliomyelitis Vaccine (REPEVAX) and Influenza Vaccine (VAXIGRIP) in Subjects Aged From 60 Years Old
Official Title
An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older
Brief Summary
Primary objectives:
To demonstrate that REPEVAX and VAXIGRIP administered concomitantly in subjects 60 years of
age and older are at least as immunogenic as REPEVAX or VAXIGRIP administered separately.
Secondary objectives:
•Secondary immunogenicity objectives: To describe the immune responses 28 days after
concomitant or separate administration of REPEVAX and VAXIGRIP in subjects 60 years of age
and older To describe the immune response of VAXIGRIP according to European Medicines Agency
criteria in subjects 60 years of age and older (Note for Guidance, 1997: 28)
•Secondary safety objective: To describe the safety profile after vaccination in each group
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Diphtheria seroprotection rate
Secondary Outcome
Solicited injection-site reactions, solicited systemic adverse reactions
Condition
Diphtheria
Intervention
Concomitant administration
Study Arms / Comparison Groups
1- VAXIGRIP and REPEVAX concomitantly
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
954
Start Date
October 2010
Completion Date
September 2011
Primary Completion Date
September 2011
Eligibility Criteria
Inclusion Criteria:
- Adults aged ≥60 years
- At least one documented booster dose with a tetanus- and diphtheria-containing vaccine
between 5 and 15 years
- No influenza vaccine administered during the last 6 months
Exclusion Criteria:
- Receipt of a booster dose with a tetanus or diphtheria- or poliomyelitis- containing
vaccine within the last 5 years
- Receipt of pertussis-containing vaccine or pertussis disease within the last 10 years
- Receipt of medication / vaccine that may interfere with study assessments
- Febrile illness or moderate or severe acute illness/infection
- History of hypersensitivity or anaphylactic or other allergic reactions to any of the
vaccine components, or history of a life-threatening reaction to the study vaccines or
a vaccine containing any of the same substances
- History of Guillain Barré syndrome or brachial neuritis following a previous
vaccination
- History of encephalopathy of unknown origin within 7 days after immunization with a
pertussis-containing vaccine or unstable neurological disorders
- Known or suspected immune dysfunction
- Thrombocytopenia, bleeding disorder or anticoagulants contraindicating intramuscular
vaccination
- Chronic disease that is unstable or any intercurrent illness that might interfere with
the ability to participate fully in the study; or interfere with evaluation of the
vaccine
Gender
All
Ages
60 Years - 99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Medical Director, ,
Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT01249183
Organization ID
RPV03C
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