Clinical trial NCT01249183: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Keywords: Diphtheria
Tetanus
Pertussis (acellular, component)
Diphteria
Biological / vaccine
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-11-29
Enrollment: 954
Sex: ALL
Minimum age (years): 60
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Diphtheria seroprotection rate
timeFrame: 28 to 35 days after vaccine administration
measure: Tetanus seroprotection rate
timeFrame: 28 to 35 days after vaccine administration
measure: Polio seroprotection rate
timeFrame: 28 to 35 days after vaccine administration
measure: Pertussis antibody titre
timeFrame: 28 to 35 days after vaccine administration
measure: Flu geometric mean of titres ratio
timeFrame: 28 to 35 days after vaccine administration
Secondary outcomes:
measure: Solicited injection-site reactions, solicited systemic adverse reactions
timeFrame: From Day 0 to Day 7 following REPEVAX vaccination
measure: Unsolicited injection-site adverse reactions and systemic adverse events
timeFrame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
measure: Number and proportion of Serious adverse events
timeFrame: From the first visit to the last visit of the subject
Other outcomes:
Locations:
city: Angers
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Châtellerault
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Clermont-Ferrand
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Gieres
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Grenoble
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Hérouville Saint-Clair
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: La Rochelle
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Lyon
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Poitiers
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Strasbourg
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Tierce
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Tours
country: France
facility: Sanofi Pasteur MSD Investigational Site
city: Berlin
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Dresden
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Essen
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Hamburg
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Heilbronn
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Künzing
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Potsdam
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
city: Reichenbach
country: Germany
facility: Sanofi Pasteur MSD Investigational Site
Study officials:
affiliation: Sanofi Pasteur, a Sanofi Company
name: Medical Director
role: STUDY_DIRECTOR
References: