Ignite Creation Date:
2024-05-06 @ 8:13 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06298708
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-01
Brief Title:
Immunogenicity and Safety of Inactivated and Live-attenuated HAV Vaccine Among Thai Healthy Children and Adolescents
Sponsor:
Chiang Mai University
Organization:
Chiang Mai University
Study Overview
Official Title:
Comparison of Immunogenicity and Safety of Inactivated and Live-attenuated Hepatitis A Virus Vaccine Among Thai Healthy Children and Adolescents A Randomized Active-controlled Open-label Non-inferiority Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
HAV-RCT
Brief Summary:
Hepatitis A virus HAV vaccine is an effective strategy to prevent natural HAV infection In Thailand there are 2 types of HAV vaccine available including inactivated HAV vaccine and live-attenuated HAV vaccine This study aims to compare the immunogenicity and safety of inactivated and lived-attenuated HAV vaccine among Thai healthy children and adolescents age 18 months to 18 years
Detailed Description:
Hepatitis A virus HAV infection is one of the common cause of viral hepatitis in children and adolescents in developing countries including Thailand This virus is easily transmitted through ingestion of contaminated food and water or through direct contact with an infectious person Generally HAV causes acute hepatitis ranging mild illness to severe fulminant hepatitis acute liver failure but does not cause chronic liver disease HAV vaccine is an effective strategy to prevent natural HAV infection as well as serious consequences of the illness
Currently there are 2 types of HAV vaccine available in Thailand including 1 inactivated vaccine I-HAV which is recommended for 2 doses 6 months apart and is approved for children age 1 year and above and 2 live-attenuated vaccine L-HAV which is recommended for 1 dose and is approved for children age 18 months and above However these vaccines have not included in the Thailand Expanded Programme on Immunization EPI yet Thus vaccination coverage rate is suboptimal in the country Moreover the information regarding immunogenicity and safety of both vaccines is limited
This is a randomized active-controlled open-label non-inferiority trial which aims to compare the immunogenicity and safety of a marketed inactivated I-HAV and a live-attenuated HAV vaccine L-HAV among Thai healthy children and adolescents age 18 months to 18 years This study will provide important information about the immunogenicity and safety profiles of both vaccines in Thai healthy youth as well as demonstrate the associated factors of HAV vaccine-elicited immunity in this population
Currently there are 2 types of HAV vaccine available in Thailand including 1 inactivated vaccine I-HAV which is recommended for 2 doses 6 months apart and is approved for children age 1 year and above and 2 live-attenuated vaccine L-HAV which is recommended for 1 dose and is approved for children age 18 months and above However these vaccines have not included in the Thailand Expanded Programme on Immunization EPI yet Thus vaccination coverage rate is suboptimal in the country Moreover the information regarding immunogenicity and safety of both vaccines is limited
This is a randomized active-controlled open-label non-inferiority trial which aims to compare the immunogenicity and safety of a marketed inactivated I-HAV and a live-attenuated HAV vaccine L-HAV among Thai healthy children and adolescents age 18 months to 18 years This study will provide important information about the immunogenicity and safety profiles of both vaccines in Thai healthy youth as well as demonstrate the associated factors of HAV vaccine-elicited immunity in this population
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