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. (Clodivac)

NCT05480462 Phase 3 UNKNOWN

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.

Details

Lead sponsor	IBSS Biomed S.A.
Phase	Phase 3
Status	UNKNOWN
Enrolment	200
Start date	2022-12-12
Completion	2024-06

Conditions

• Diphtheria
• Tetanus

Interventions

• Clodivac
• Td-Impfstoff Merieux

Primary outcomes

• Seroconversion — 28 days
  The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.

Countries

Poland