Phase IV Study of Concomitant Administration of the sIPV and HepA
NCT Number: NCT06460545
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Polio|Hepatitis A
Interventions: BIOLOGICAL: sIPV (booster dose at 18 months of age)|BIOLOGICAL: HepA-L|BIOLOGICAL: HepA-I
Sponsor: Institute of Medical Biology, Chinese Academy of Medical Sciences
Sex: ALL
Age: CHILD
Enrollment: 2000
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
Start Date: 2024-06-15
Completion Date: 2027-12-15
Locations: Jiu Longpo District Center for Disease Control and Disease, Chongqing, Chongqing, China|Wanzhou District Center for DIsease Control and Prevention, Chongqing, Chongqing, China|Jiangjin District Center for Disease Control and Prevention, Chongqing, Chonqing, China

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.

Primary Outcome Measures: Immunogenicity index-seroconversion rate of type I anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline, Between baseline and day 30 after vaccination|Immunogenicity index-seroconversion rate of type II anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline, Between baseline and day 30 after vaccination|Immunogenicity index-seroconversion rate of type III anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as a change from seronegative (\<1:8) to seropositive (≥1:8), or a ≥4-fold increase from baseline, Between baseline and day 30 after vaccination|Immunogenicity index-seropositive rate of type I anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8)., Day 30 after vaccination|Immunogenicity index-seropositive rate of type II anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8)., Day 30 after vaccination|Immunogenicity index-seropositive rate of type III anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method. Seroconversion will be defined as the level (≥1:8)., Day 30 after vaccination|Immunogenicity index-seroconversion rate of anti-hepatitis A virus antibody, Antibody assay will be performed using the ELISA method. Seroconversion will be defined as a change from seronegative (\<20mIU/ml) to seropositive (≥20mIU/ml), or a ≥4-fold increase from baseline, Between baseline and day 30 after vaccination
Secondary Outcome Measures: Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Day 30 after vaccination|Immunogenicity index-geometric mean titer (GMT) of type II anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Day 30 after vaccination|Immunogenicity index-geometric mean titer (GMT) of type III anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Day 30 after vaccination|Immunogenicity index-geometric mean concentration (GMC) of anti-hepatitis A virus antibody, Antibody assay will be performed using the ELISA method., Day 30 after vaccination|Immunogenicity index-seropositive rate of anti-hepatitis A virus antibody, Antibody assay will be performed using the ELISA method. Seropositive will be defined as the level (≥20mIU/ml)., Day 30 after vaccination|Immunogenicity index-geometric mean fold increase (GMFI) of type I anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Between baseline and Day 30 after vaccination|Immunogenicity index-geometric mean fold increase (GMFI) of type II anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Between baseline and Day 30 after vaccination|Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody, Neutralizing antibody assay will be performed using the neutralization method., Between baseline and Day 30 after vaccination|Immunogenicity index-geometric mean fold increase (GMFI) of anti-hepatitis A virus antibody, Antibody assay will be performed using the ELISA method., Between baseline and Day 30 after vaccination|Safety index-incidence of adverse events, Incidence of adverse events after vaccination, 0-30 minutes after vaccination|Safety index-incidence of solicited adverse events, Incidence of solicited local and systematic adverse events after vaccination, Day 0-7 or Day 0-14 after vaccination|Safety index-incidence of unsolicited adverse events, Incidence of unsolicited adverse events after vaccination, Day 0-30 after vaccination|Safety index-incidence of adverse events, Incidence of adverse events after vaccination, Day 0-30 after vaccination|Safety index-incidence of serious adverse events, Incidence of serious adverse events, From the beginning of the vaccination up to 6 months after vaccination completed