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Study of Concomitant Administration of the sIPV and DTaP or MMR
Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
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
sIPV
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose
DTaP
Adsorbed acellular pertussis, diphtheria and tetanus combined vaccine, 0.5mL for each dose
bOPV 1,3
Poliomyelitis Vaccine Type I Type Ⅲ in Dragee Candy (Human Diploid Cell), Live, 1g for each dose
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