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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
200
A dose of 0.5 ml should be administered intramuscularly into deltoid muscle.
One dose (0.5 ml) intramuscular, preferably in the deltoid muscle of the upper arm.
SPZOZ w Bochni Szpital Powiatowy im. bł. M. Wieckiej
Bochnia, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawła II
Krakow, Poland
Seroconversion
The primary endpoint is the seroconversion in 28 days follow-up. The proportion of subjects complying the positive criteria of seroconversion will be calculated.
Time frame: 28 days
The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies and diphtheria antibodies between test and reverence.
1. The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU. 2. The ratio of geometric mean concentrations (GMC) of post-vaccination diphtheria antibodies between test and reference va1. The ratio of geometric mean concentrations (GMC) of post-vaccination tetanus antibodies between test and reference vaccine in 28 days FU.
Time frame: 28 days
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