Diphtheria, Pertussis, Poliomyelitis, Tetanus
Conditions
Keywords
Diphtheria, Tetanus, Pertussis (acellular, component), Diphteria, Biological / vaccine
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
Interventions
BIOLOGICALConcomitant 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)
BIOLOGICALSeparate administration
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
Sponsors
Sanofi Pasteur, a Sanofi Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to 99 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Flu geometric mean of titres ratio | 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 |
| Diphtheria seroprotection rate | 28 to 35 days after vaccine administration |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Solicited injection-site reactions, solicited systemic adverse reactions | From Day 0 to Day 7 following REPEVAX vaccination |
Countries
France, Germany
Outcome results
None listed