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Study of Concomitant Administration of the sIPV and DTaP or MMR

NCT06920069 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2640

Last updated 2025-04-17

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

sIPV

Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose

BIOLOGICAL

DTaP

Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose

BIOLOGICAL

bOPV 1,3

Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose

BIOLOGICAL

MMR Vaccine

Measles, Mumps and Rubella Combined Live-attenuated Vaccine, 0.5mL for each dose

Sponsors & Collaborators

  • Institute of Medical Biology, Chinese Academy of Medical Sciences

    lead OTHER

Principal Investigators

  • Yan Zheng · Yunnan Provical Center for Disease Control and Prevention

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
2 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-15
Primary Completion
2030-07-15
Completion
2031-06-15

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

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 NCT06920069 on ClinicalTrials.gov