Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00137930
Status:
COMPLETED
Last Update Posted:
2016-09-21
First Post:
2005-08-29
Brief Title:
Study of Immunogenicity Safety of 2 Different Formulations of Human Rotavirus HRV Vaccine for the Prophylaxis of Rotavirus Gastroenteritis
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Compare the Immunogenicity Reactogenicity Safety of 2 Different Formulations of GSK Biologicals Live Attenuated Human Rotavirus HRV Vaccine Given as a Two-dose Primary Vaccination in Healthy Infants Previously Uninfected With HRV
Status:
COMPLETED
Status Verified Date:
2016-09
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:
Rotavirus RV is the most important cause of acute gastroenteritis GE requiring the hospitalization of infants and young children in developed and developing countries and can be a frequent cause of death in children less than 5 years of age estimated nearly 500000 annual deaths worldwide GlaxoSmithKline GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis A new formulation of the vaccine with an alternative buffer was developed This study will be conducted to evaluate the new formulation compared to the existing formulation of the HRV vaccine
Detailed Description:
The study consists of four groups of children recruited in different centers in Finland One group of children will receive the existing formulation of HRV vaccine and one group will receive the new formulation of the HRV vaccine The other two groups will receive the placebo for existing formulation or the new formulation based on the allocation The vaccine or placebo will be administered starting at 6 - 12 weeks of age according to 0 1 month schedule Routine childhood vaccinations are allowed according to local practice but at least 14 days apart from each dose of study vaccine The duration of the study will be approximately 2 months per child
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