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NOT YET RECRUITING
NCT06920069
PHASE4

Study of Concomitant Administration of the sIPV and DTaP or MMR

Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences

View on ClinicalTrials.gov

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.

Official title: Phase IV Study of Evaluating Immunogenicity and Safety of Concomitant Administration of Sabin-strain-based Inactivated Poliovirus Vaccine (Vero Cells) and Adsorbed Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine or Measles, Mumps and Rubella Combined Live-attenuated Vaccine

Key Details

Gender

All

Age Range

2 Months - 2 Months

Study Type

INTERVENTIONAL

Enrollment

2640

Start Date

2025-05-15

Completion Date

2031-06-15

Last Updated

2025-04-17

Healthy Volunteers

Yes

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

Locations (9)

Lufeng Center for Disease Control and Prevenion

Chuxiong, Yunnan, China

Yuanmou Center for Disease Control and Prevention

Chuxiong, Yunnan, China

Wuding Center for Disease Control and Prevention

Chuxiong, Yunnan, China

Yaoan Center for Disease Control and Prevention

Chuxiong, Yunnan, China

Lancang Center for Disease Control and Prevention

Puer, Yunnan, China

Yanshan Center for Disease Control and Prevention

Wenshan, Yunnan, China

Qiubei Center for Disease Control and Prevention

Wenshan, Yunnan, China

Guangnan Center for Disease Control and Prevention

Wenshan, Yunnan, China

Mile Center for Disease Control and Prevention

Yisa, Yunnan, China