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Phase IV Study of Concomitant Administration of the sIPV and HepA
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 HepA-L or HepA-I in children aged 18 months. The primary immunogenicity endpoints in all groups are the seroconversion rates of type I, II, and III anti-poliovirus neutralizing antibodies and the seroconversion rate of anti-hepatitis A virus antibodies 30 days after the final administration. The secondary immunogenicity endpoints are (1) the GMT/GMC of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration; (2) the seropositive rates of the anti-hepatitis A virus antibodies 30 days after the final administration; (3) the GMFI of type I, II, and III anti-poliovirus neutralizing antibodies as well as the anti-hepatitis A virus antibodies 30 days after the final administration. 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 Freeze-dried Live-attenuated Hepatitis A Vaccine or Inactivated Hepatitis A Vaccine
Key Details
Gender
All
Age Range
4 Months - 4 Months
Study Type
INTERVENTIONAL
Enrollment
2000
Start Date
2024-06-15
Completion Date
2027-12-15
Last Updated
2024-06-14
Healthy Volunteers
Yes
Conditions
Interventions
sIPV (booster dose at 18 months of age)
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one
HepA-L
Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age
HepA-I
Inactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively
Locations (3)
Jiu Longpo District Center for Disease Control and Disease
Chongqing, Chongqing Municipality, China
Wanzhou District Center for DIsease Control and Prevention
Chongqing, Chongqing Municipality, China
Jiangjin District Center for Disease Control and Prevention
Chongqing, Chonqing, China