NCT05480462

Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

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: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: IBSS Biomed S.A. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diphtheria
• Tetanus

Interventions

Type	Name	Description
BIOLOGICAL	Clodivac	A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
BIOLOGICAL	Td-Impfstoff Merieux	One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.

Timeline

• Start date: 2022-12-12
• Primary completion: 2024-03-04
• Completion: 2024-06-01
• First posted: 2022-07-29
• Last updated: 2024-02-05

Locations

2 sites across 1 country: Poland