Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT06460545
Study type Interventional
Source Institute of Medical Biology, Chinese Academy of Medical Sciences
Contact Jingsi Yang
Phone 0871-68334551
Email yjs@imbcams.com.cn
Status Not yet recruiting
Phase Phase 4
Start date June 15, 2024
Completion date December 15, 2027

See also
  Status Clinical Trial Phase
Withdrawn NCT03445416 - Increasing Healthcare Engagement Via Routine Vaccination Among Young Black Men Who Have Sex With Men N/A
Completed NCT01949857 - The Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines Phase 4
Completed NCT00313950 - Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine Phase 4
Completed NCT00139139 - A Study to Compare the Efficacy of Hepatitis A Vaccine and Immune Globulin When Given After Exposure to Hepatitis A N/A
Completed NCT00197171 - Long Term F/U Studies at Y5&6 to Demonstrate the Equivalence of 2 Vaccination Schedules of Combined Hepatitis A & B Vaccine Phase 3
Completed NCT00139113 - Immunogenicity Study of an Inactivated Hepatitis A Vaccine in Infants and Young Children Phase 4
Completed NCT03312699 - Effects of Aging on Primary and Secondary Vaccine Responses in a 15-Year Longitudinal Cohort Phase 1
Completed NCT03855176 - Effectiveness of Booster With 1 or 2 Doses of HAV Vaccine Among HIV-infected Patients Phase 4
Completed NCT00197002 - Immune Response & Safety of a Hepatitis A Vaccine Given Together With a Pneumococcal Vaccine in Healthy Children 15 m of Age Phase 3
Withdrawn NCT02605538 - Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively N/A
Completed NCT04638335 - What is the Anti-HAV Seroprevalence of Travelers >60 Years or Having Lived in a Tropical Country for >5 Years
Completed NCT00197015 - Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children Phase 3
Active, not recruiting NCT06058416 - Immunogenicity and Safety of Hepatitis A Among People Aged 18-50 Years Old Phase 4
Completed NCT01453348 - Study to Evaluate the Safety and Immunogenicity of Combined Hepatitis A/B Vaccine With MenACWY-CRM Conjugate Vaccine Phase 3
Completed NCT01865968 - Comparison of Immunogenicity and Safety of Inactivated and Live Attenuated Hepatitis A Vaccines in Young Adults Phase 4
Completed NCT02002065 - The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children N/A
Terminated NCT00119743 - A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine Phase 3
Completed NCT01000324 - Antibody Persistence & Immune Memory in Healthy Adults Previously Vaccinated With Twinrix Adult Phase 4
Completed NCT00289731 - Effect of Risk Factors Likely to Influence Immuno of Combined Hepatitis A & B Vacc vs Monovalent Hepatitis A & B Vacc Phase 4
Completed NCT02300792 - The Effects of Honey, as a Dietary Supplement in Children With Hepatitis A Phase 2