Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-02-11 @ 12:53 AM
Study NCT ID:
NCT01502969
Status:
COMPLETED
Last Update Posted:
2012-01-02
First Post:
2011-10-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Immunogenicity Assessment of Rotavin-M1 in Vietnamese Children
Sponsor:
National Institute of Hygiene and Epidemiology, Vietnam
Organization:
Study Overview
Official Title:
A Phase 2b Study of Rotavin-M1 Vaccine in Vietnamese Children
Status:
COMPLETED
Status Verified Date:
2011-12
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:
Rotavin-M1
Brief Summary:
This is a multiple-site phase 2b, randomized, placebo control study to evaluate the safety and immunogenicity of Rotavin-M1, produced by the Center for Research and Production of Vaccines and Biologicals, Vietnam.
Detailed Description:
The investigators evaluate the vaccine schedule consisting of 2 doses of Rotavin-M1, 10e6.3ffu/dose at 2 month interval in children in two study sites, Thanh Son- Phu Tho and Thai Binh city-Thai Binh provinces.
This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).
This vaccine dose and schedule was chosen based on results from the previous dose-escalating study (NCT01377571).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: