Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169455
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2005-09-09
Brief Title:
Assess the Immunogenicity of the Human Rotavirus HRV Vaccine After Reconstitution Without Buffering Agent Evaluate the Immunogenicity Reactogenicity Safety of the Vaccine After Storage for 7 d at 37C Following 2 Doses in Healthy Infants
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
A Phase IIIb Partially Blind Randomized Placebo-controlled Study to Asses the Effect on Immunogenicity of Administration of Vaccine Without Buffering Agent and to Assess Heat Stability in Terms of Immunogenicity Reactogenicity and Safety of GlaxoSmithKline Biologicals Oral Live Attenuated Human Rotavirus HRV Vaccine Following a 0 2 Month Schedule in Healthy Infants Previously Uninfected With Human Rotavirus
Status:
COMPLETED
Status Verified Date:
2017-01
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 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 GSK Biologicals has developed a vaccine against human rotavirus gastroenteritis In this study the immunogenicity reactogenicity and safety of the HRV vaccine will be evaluated when stored or reconstituted in circumstances different from the recommendations ie when not reconstituted with a buffer or when stored for 7 days at 37C before reconstitution In addition the effect of feeding will be explored for HRV vaccine reconstituted without buffer
Detailed Description:
Assess the effect on immunogenicity of administration of vaccine without buffering agent assess heat stability in terms of immunogenicity reactogenicity safety of GSK Biologicals oral live attenuated human rotavirus HRV vaccine following a 02 m schedule in healthy infants previously uninfected with human rotavirus
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