Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT06460545
PHASE4

Phase IV Study of Concomitant Administration of the sIPV and HepA

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 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

Interventions

BIOLOGICAL

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

BIOLOGICAL

HepA-L

Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age

BIOLOGICAL

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