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 Pasteur, a Sanofi Company954 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

954

Conditions

Diphtheria Tetanus Pertussis Poliomyelitis

Concomitant administrationBIOLOGICAL

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 administrationBIOLOGICAL

1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later

Eligibility

Sex: ALLMin age: 60 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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