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
Phase 3
Completed
- Conditions
- TetanusPertussisDiphtheriaPoliomyelitis
- Interventions
- Biological: Concomitant administrationBiological: Separate administration
- Registration Number
- NCT01249183
- Lead Sponsor
- Sanofi Pasteur, a Sanofi Company
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 954
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1- VAXIGRIP and REPEVAX concomitantly Concomitant administration - 2-REPEVAX 28 days after VAXIGRIP Separate administration -
- Primary Outcome Measures
Name Time Method Pertussis antibody titre 28 to 35 days after vaccine administration Flu geometric mean of titres ratio 28 to 35 days after vaccine administration Diphtheria seroprotection rate 28 to 35 days after vaccine administration Tetanus seroprotection rate 28 to 35 days after vaccine administration Polio seroprotection rate 28 to 35 days after vaccine administration
- Secondary Outcome Measures
Name Time Method Number and proportion of Serious adverse events From the first visit to the last visit of the subject Unsolicited injection-site adverse reactions and systemic adverse events From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination Solicited injection-site reactions, solicited systemic adverse reactions From Day 0 to Day 7 following REPEVAX vaccination
Trial Locations
- Locations (1)
Sanofi Pasteur MSD Investigational Site
🇩🇪Reichenbach, Germany