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
NCT ID: NCT01249183
Last Updated: 2017-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
954 participants
INTERVENTIONAL
2010-10-31
2011-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1- VAXIGRIP and REPEVAX concomitantly
Concomitant administration
1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
2-REPEVAX 28 days after VAXIGRIP
Separate administration
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
Interventions
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Concomitant administration
1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
Separate administration
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
Eligibility Criteria
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Inclusion Criteria
* 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 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
60 Years
99 Years
ALL
Yes
Sponsors
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Sanofi Pasteur, a Sanofi Company
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur, a Sanofi Company
Locations
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Sanofi Pasteur MSD Investigational Site
Angers, , France
Sanofi Pasteur MSD Investigational Site
Châtellerault, , France
Sanofi Pasteur MSD Investigational Site
Clermont-Ferrand, , France
Sanofi Pasteur MSD Investigational Site
Gières, , France
Sanofi Pasteur MSD Investigational Site
Grenoble, , France
Sanofi Pasteur MSD Investigational Site
Hérouville-Saint-Clair, , France
Sanofi Pasteur MSD Investigational Site
La Rochelle, , France
Sanofi Pasteur MSD Investigational Site
Lyon, , France
Sanofi Pasteur MSD Investigational Site
Poitiers, , France
Sanofi Pasteur MSD Investigational Site
Strasbourg, , France
Sanofi Pasteur MSD Investigational Site
Tiercé, , France
Sanofi Pasteur MSD Investigational Site
Tours, , France
Sanofi Pasteur MSD Investigational Site
Berlin, , Germany
Sanofi Pasteur MSD Investigational Site
Dresden, , Germany
Sanofi Pasteur MSD Investigational Site
Essen, , Germany
Sanofi Pasteur MSD Investigational Site
Hamburg, , Germany
Sanofi Pasteur MSD Investigational Site
Heilbronn, , Germany
Sanofi Pasteur MSD Investigational Site
Künzing, , Germany
Sanofi Pasteur MSD Investigational Site
Potsdam, , Germany
Sanofi Pasteur MSD Investigational Site
Reichenbach, , Germany
Countries
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Other Identifiers
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RPV03C
Identifier Type: -
Identifier Source: org_study_id
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