Clinical Trial

Phase I Clinical Trial of Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine

Recruiting Phase 1
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Record status
This record was last updated January 3, 2024 (before its estimated December 15, 2024 completion). Its status may not reflect the trial's current state.
Summary
This study is a randomized, blinded, active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Diphtheria-Tetanus-acellular Pertussis Component Combined Vaccine (DTacP) in subjects (aged 2 months to 6 years). Primary safety endpoints are the occurrence of solicited adverse events within 30 minutes after each dose, the occurrence of solicited adverse events within 7 days after each dose, the occurrence of unsolicited adverse events within 30 days after each dose, and the occurrence of adverse events 30 days after immunization. The secondary safety endpoint is the occurrence of serious adverse events (SAEs) within 12 months after immunization. Secondary immunogenicity endpoints are the geometric mean concentration (GMC), geometric mean fold increase (GMFI), seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after immunization. The exploratory endpoints are the GMC, GMFI, seropositive rates, seroconversion rates, or 4-fold increase rates of anti-DT, anti-PT, and anti-FHA neutralizing antibodies 30 days after immunization in all groups, the GMC and seropositive rates of anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 12 months after primary immunization in the infant group, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 30 days after immunization in all groups, the seropositive rates and geometric mean tie (GMT) of anti- type I, type II, type III poliovirus neutralizing antibodies 12 months after primary immunization in the infant group.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-12-14.
Status change: Not Yet Recruiting → Recruiting 2024-01-01
Trial Details
NCT Number NCT06184542
Lead Sponsor Institute of Medical Biology, Chinese Academy of Medical Sciences
Collaborators: Sichuan Center for Disease Control and Prevention
Conditions Diphtheria, Tetanus, Pertussis
Enrollment 460 participants
Start Date 2023-12-23
Primary Completion 2024-12-15 (estimated)
Study Completion 2026-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-01-03