At a glance
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A Phase 4, Randomized, Open-label Trial Evaluating the Safety, Tolerability, and Immunogenicity of DTaP Vaccine in Healthy Infants Given With a 7-valent Pneumococcal Conjugate Vaccine in Japan.
In Brief
A Phase 4 clinical trial evaluating 7-pneumococcal conjugate vaccine (7vPnC), diphtheria, tetanus, and acellular pertussis vaccine (DTaP), and 1 other intervention for Healthy Subjects. Completed, enrolled 321 participants across 18 sites.
Detailed Summary
Subjects will be randomly assigned to 1 of 2 groups to receive the following vaccines: Group 1: 7-valent pneumococcal conjugate vaccine (7vPnC) and diphtheria, tetanus, and accelular pertussis vaccine (DTaP), Group 2: DTaP alone. Group 2 subjects will also receive catch-up doses of 7vPnC. The study vaccines will be open-label. The main purpose of the study is to demonstrate that the immune responses as measured by serum antibody responses to diphtheria toxin, tetanus toxin, pertussis toxin (PT) and filamentous haemagglutinin (FHA) induced by DTaP given concomitantly with 7vPnC are comparable to the immune responses induced by DTaP given alone. In addition, the study aims to evaluate the side effects (safety profile) after vaccination of 7vPnC when given with DTaP in healthy Japanese infants.
Study Details
Timeline
Interventions
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses
0.5 mL per dose, 4 doses