Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460545
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Phase IV Study of Concomitant Administration of the sIPV and HepA
Sponsor:
Institute of Medical Biology Chinese Academy of Medical Sciences
Organization:
Institute of Medical Biology Chinese Academy of Medical Sciences
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 GMTGMC 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
Detailed 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 44433 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 orand anti-hepatitis A virus antibody for different groups
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 orand anti-hepatitis A virus antibody for different groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None