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Immunogenicity and Safety of Vaccine Against Tetanus and Diphtheria.

NCT05480462 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-02-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • IBSS Biomed S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-12
Primary Completion
2024-03-04
Completion
2024-06-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05480462 on ClinicalTrials.gov