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

Study Overview
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Brief Summary
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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

Official Title
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An Open-label, Randomised, Multicentre Study to Evaluate the Immunogenicity and Safety of a Booster Dose of Diphtheria, Tetanus, Acellular Pertussis and Inactivated Poliomyelitis Adsorbed Vaccine (REPEVAX) Administered Concomitantly Versus Non-concomitantly With an Influenza Vaccine (VAXIGRIP) to Subjects of 60 Years of Age and Older

Conditions
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Diphtheria, Tetanus, Pertussis, Poliomyelitis

Intervention / Treatment
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* Biological: Concomitant administration
* Biological: Separate administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1- VAXIGRIP and REPEVAX concomitantly<br> | Biological: Concomitant administration<br>* 1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)<br>|
| Active Comparator: 2-REPEVAX 28 days after VAXIGRIP<br> | Biological: Separate administration<br>* 1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Pertussis antibody titre |  | 28 to 35 days after vaccine administration | 
| Flu geometric mean of titres ratio |  | 28 to 35 days after vaccine administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited injection-site reactions, solicited systemic adverse reactions |  | From Day 0 to Day 7 following REPEVAX vaccination | 
| Unsolicited injection-site adverse reactions and systemic adverse events |  | From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination | 
| Number and proportion of Serious adverse events |  | From the first visit to the last visit of the subject | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diphtheria, Tetanus, Pertussis (acellular, component), Diphteria, Biological / vaccine