Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06442449
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-29
Brief Title:
Booster Dose of sIPV Co-administered With MMR and HepA-I
Sponsor:
Sinovac Biotech Co Ltd
Organization:
Sinovac Biotech Co Ltd
Study Overview
Official Title:
Open-labeled Randomized Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of sIPV Co-administered With MMR and HepA-I
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 is an Open-labeled Randomized Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of Booster Dose of Sabin Strain Inactivated Poliovirus Vaccine Vero cell sIPV Co-administered with Measles Mumps Rubella MMR Combined Live Attenuated Vaccine and Inactivated Hepatitis A Hep-A Vaccine
Detailed Description:
The trial plans to enroll 960 infants aged 18 months 4 months who had completed three primary doses of sIPV vaccine and were assigned in a 22211 ratio to four groups including trial group 1 trial group 2 control group 1 control group 2 control group 2 with informed consent from the participants guardian Trial group 1 receive one dose of sIPV co-administered with one dose of MMR vaccine Trial group 2 receive one dose of sIPV co-administered with one dose of inactivated hepatitis A vaccine Control group 1 receive one dose of sIPV control group 2 receive one dose of MMR vaccine and control group 3 receive one dose of inactivated hepatitis A vaccine About 30 ml of venous blood will be collected from all participants before and 30 days after vaccination for antibody detection Immediate reactions will be observed for 30 minutes after vaccination and adverse events occured from 0 to day 30 after vaccination will be collected
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