Status:
COMPLETED
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
Lead Sponsor:
Sanofi Pasteur, a Sanofi Company
Conditions:
Diphtheria
Tetanus
Eligibility:
All Genders
60-99 years
Phase:
PHASE3
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 separatel...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
954 Patients enrolled
Trial Details
Trial ID
NCT01249183
Start Date
October 1 2010
End Date
September 1 2011
Last Update
September 11 2017
Active Locations (20)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi Pasteur MSD Investigational Site
Angers, France
2
Sanofi Pasteur MSD Investigational Site
Châtellerault, France
3
Sanofi Pasteur MSD Investigational Site
Clermont-Ferrand, France
4
Sanofi Pasteur MSD Investigational Site
Gières, France