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.
This is a randomized, open-labeled, parallel phase IV clinical trial to evaluate the immunogenicity and safety of concomitant administration of sIPV and HepA-L or HepA-I. 2000 children subjects aged 4 months will be enrolled to take administration of 1 dose of sIPV. All participants at 18 months of age will be randomly assigned to 5 cohorts in a ratio of 4:4:4:3:3, that is, (1) 400 subjects will be concomitantly injected with sIPV and HepA-L, (2) 400 subjects will be concomitantly injected with sIPV and HepA-I, and another dose of HepA-I at 24 months of age (3) 400 subjects will be only injected one dose of sIPV, (4) 300 subjects will be only injected with one dose of HepA-L, (5) 300 subjects will be only injected with two doses of HepA-I at 18 and 24 months of age, respectively. For safety assessment, adverse events after the third dose of sIPV at 4 months of age would be collected through phone-call follow-ups on Day 8 and Day 30 after the injection by investigators and active reports from participants' guardians. At 18 months of age, safety data would be recorded through the diary and contact cards by participants' guardians to collect solicited or unsolicited AEs in periods of solicitation and nonsolicitation, respectively. From 31 days after the final dose to 6 months later, serious adverse events will be evaluated by the investigator via phone call or active reports by participants' guardians. For immunogenicity assessment, blood samples before each dose on Day 0 and Day 30 after each injection would be collected to evaluate the type I, II, and III anti-poliovirus neutralizing antibody levels or/and anti-hepatitis A virus antibody for different groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,000
Sabin-strain-based inactivated vaccine (Vero cells), 0.5mL for each dose at 18 months of age for the booster one
Freeze-dried/lyophilized live-attenuated hepatitis A virus vaccine, 1.0mL for each dose at 18 months of age
Inactivated hepatitis A virus vaccine, 0.5mL for each dose, two doses at 18 and 24 months of age, respectively
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
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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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
Time frame: Between baseline and day 30 after vaccination
Immunogenicity index-geometric mean titer (GMT) of type I anti-poliovirus neutrilizing antibody
Neutralizing antibody assay will be performed using the neutralization method.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Between baseline and Day 30 after vaccination
Immunogenicity index-geometric mean fold increase (GMFI) of type III anti-poliovirus neutrilizing antibody
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Neutralizing antibody assay will be performed using the neutralization method.
Time frame: 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.
Time frame: Between baseline and Day 30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Time frame: 0-30 minutes after vaccination
Safety index-incidence of solicited adverse events
Incidence of solicited local and systematic adverse events after vaccination
Time frame: Day 0-7 or Day 0-14 after vaccination
Safety index-incidence of unsolicited adverse events
Incidence of unsolicited adverse events after vaccination
Time frame: Day 0-30 after vaccination
Safety index-incidence of adverse events
Incidence of adverse events after vaccination
Time frame: Day 0-30 after vaccination
Safety index-incidence of serious adverse events
Incidence of serious adverse events
Time frame: From the beginning of the vaccination up to 6 months after vaccination completed