The purpose of this study is to demonstrate that a combined adult Tdap-IPV vaccine (REPEVAX®) will provide similar rapid antibody responses against tetanus toxoid as a tetanus toxoid vaccine alone in healthy adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
52
1 dose of 0.5 mL at Day 0
1 dose of 0.5 mL at Day 0
Hôpital Gabriel Montpied - CHU Clermont-Ferrand
Clermont-Ferrand, France
Hôpital St Eloi
Montpellier, France
Groupe Hospitalier Cochin - Saint-Vincent de Paul
Paris, France
Hôpital Bichat Claude Bernard
Paris, France
Anti-tetanus seroprotection rate (defined as the percentage of subjects with anti-tetanus antibody titre (ELISA) ≥ 0.1 IU/mL)
Time frame: 10 days
Geometric Mean Titre (GMT) for tetanus antibodies in both groups
Time frame: Day 0, Day 1 and Day 28
The anti-tetanus seroprotection rate (antibody titre ≥ 0.1 IU/mL in ELISA)
Time frame: Day 28
Percentage of subjects with immediate reactions, solicited injection-site reactions, systemic reactions and unsolicited adverse events
Time frame: D0 to Day 7
Percentage of subjects with serious adverse events
Time frame: D0 to Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Unnamed facility
Heilbronn, Germany
Unnamed facility
Künzig, Germany
Unnamed facility
Nettersheim, Germany
Unnamed facility
Offenbach, Germany
Unnamed facility
Reichenbach/Vogtland, Germany