Single Blind, Randomized, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Booster Immunization With Bivalent Vaccine Against Tetanus and Diphtheria CLODIVAC (IBSS Biomed S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in Healthy Adults.
Status: Active_not_recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
A single blind, randomized, comparative, multicentre clinical trial of the immunogenicity and safety of booster immunization with bivalent vaccine against tetanus and diphtheria CLODIVAC (IBSS BIOMED S.A.) and Td-Impfstoff Mérieux (Sanofi Pasteur) in healthy adults.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:
• Approved informed consent.
• Men and women aged 18- 65 years.
• Written confirmation on previous immunization against diphtheria and tetanus not older than 16 years and not younger than 4 years.
Locations
Other Locations
Poland
SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
Bochnia
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow
Time Frame
Start Date: 2022-12-12
Completion Date: 2024-06
Participants
Target number of participants: 200
Treatments
Experimental: Clodivac
Active_comparator: Td-Impfstoff Merieux
Related Therapeutic Areas
Sponsors
Leads: IBSS Biomed S.A.