Clinical Trial

Study of Concomitant Administration of the sIPV and DTaP or MMR

Not Yet Recruiting Phase 4
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Summary
This study is a randomized, open-labeled phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and DTaP or MMR in infants aged 2 months. Primary immunogenicity endpoints in all groups include the seroconversion rate of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies 30 days after basic immunization. Secondary immunogenicity endpoints include the seropositive rates, seroconversion rates, geometric mean titer/concentration (GMT/GMC), geometric mean fold increase (GMFI) of type I, II, and III anti-poliovirus neutralizing antibodies, anti-DT, anti-TT, anti-PT, anti-FHA, and anti-PRN antibodies, and anti-measles, anti-mumps, and anti-rubella antibodies 30 days after full immunization. The secondary safety endpoints are the incidence of adverse events (AEs) within 30 minutes after each injection, the incidence of solicited local and systematic AEs in the period of solicitation after each injection, the incidence of unsolicited AEs in 30 days after each injection, the incidence of AEs in 30 days after each injection, and the incidence of serious adverse events in 6 months after administrations.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-04-02.
Trial Details
NCT Number NCT06920069
Lead Sponsor Institute of Medical Biology, Chinese Academy of Medical Sciences
Conditions Polio, Diphteria, Tetanus and Pertussis, MMR Vaccine
Enrollment 2,640 participants
Start Date 2025-05-15
Primary Completion 2030-07-15 (estimated)
Study Completion 2031-06-15 (estimated)
Updated on ClinicalTrials.gov 2025-04-17