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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Poliomyelitis

Diphtheria

Pertussis

Tetanus

Treatments

Biological: Separate administration

Biological: Concomitant administration

Study type

Interventional

Funder types

Industry

Identifiers

NCT01249183

RPV03C

Details and patient eligibility

About

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

Enrollment

954 patients

Sex

All

Ages

60 to 99 years old

Volunteers

Accepts Healthy Volunteers

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