Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00480324
Status:
COMPLETED
Last Update Posted:
2020-01-02
First Post:
2007-05-29
Brief Title:
Efficacy Safety Reactogenicity Immunogenicity of the Rotarix Vaccine in Japanese Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Efficacy Safety Reactogenicity and Immunogenicity Study of the Lyophilised Formulation of Rotarix Vaccine in Healthy Japanese Infants
Status:
COMPLETED
Status Verified Date:
2019-12
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:
None
Brief Summary:
This study is undertaken to provide the regulatory authorities in Japan with immunogenicity efficacy safety and reactogenicity data of GSK Biologicals Human Rotavirus HRV vaccine given as a 2-dose primary vaccination in healthy Japanese infants aged approximately 2 months at the time of the first dose and previously uninfected with HRV The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Combined diphtheria and tetanus toxoids and acellular pertussis DTPa and Hepatitis B HBV vaccines are allowed to be co-administered along with Rotarix vaccinePlacebo
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2015-001543-36 | EUDRACT_NUMBER | None | None |