A Phase 3 interventional study of Concomitant administration and Separate administration in Diphtheria, Tetanus and Pertussis, sponsored by Sanofi Pasteur, a Sanofi Company. Completed at 20 sites in 2 countries. Open to participants aged 60 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-09-11.
Sponsored by Sanofi Pasteur, a Sanofi Company · Phase 3, Interventional, and Prevention
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
238 studies on the registry are indexed under Whooping Cough; 15 are open to participants now.
This study's enrollment of 954 is above the median of 375 across 180 interventional studies indexed under Whooping Cough.
Browse Whooping Cough studies →Sanofi Pasteur, a Sanofi Company is the lead sponsor of 366 studies on the registry; 4 are open to participants now.
Of its 94 completed or terminated interventional studies of FDA-regulated products, 73 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Biological: Concomitant administration
Biological: Separate 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)
1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
Diphtheria seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Tetanus seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Polio seroprotection rate
Time frame: 28 to 35 days after vaccine administration
Pertussis antibody titre
Time frame: 28 to 35 days after vaccine administration
Flu geometric mean of titres ratio
Time frame: 28 to 35 days after vaccine administration
Solicited injection-site reactions, solicited systemic adverse reactions
Time frame: From Day 0 to Day 7 following REPEVAX vaccination
Unsolicited injection-site adverse reactions and systemic adverse events
Time frame: From Day 0 to Day 28 following REPEVAX and/or VAXIGRIP vaccination
Number and proportion of Serious adverse events
Time frame: From the first visit to the last visit of the subject
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Sanofi Pasteur, a Sanofi Company