To Assess Immunogenicity, Reactogenicity & Safety of 2 Formulations of GSK's HRV Vaccine as 2-Dose Vaccination (Infants)

This study has been completed.

First Received: August 11, 2006 Last Updated: October 15, 2008 History of Changes

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00363545

Purpose

This trial will be conducted to evaluate the immunogenicity, reactogenicity and safety of the liquid formulation of GSK Biologicals' HRV vaccine compared to the lyophilized formulation of GSK Biologicals' HRV vaccine

Condition	Intervention	Phase
Gastroenteritis	Biological: Lyophilized & Liquid formulation of HRV vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Study to Assess the Immunogenicity, Reactogenicity and Safety of 2 Different Formulations of GSK Bio Live Attenuated HRV Vaccine, Given as a Two-Dose Primary Vaccination, in Healthy Infants Previously Uninfected With HRV

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Anti-RV IgA antibody SC at Month 4
Safety: solicited & unsolicited adverse events and SAEs

Estimated Enrollment:	1270
Study Start Date:	September 2006
Primary Completion Date:	April 2007 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Weeks to 12 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy male or female infant between, and including, 6 and 12 weeks of age born after a gestation period of 36 to 42 weeks.
Written informed consent obtained from the parent or guardian of the subject.

Exclusion Criteria:

se of any investigational or non-registered product (drug or vaccine) other than the HRV vaccine within 30 days preceding the first dose of HRV vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Planned administration/ administration of a vaccines not foreseen by the study protocol except for DTPw, HBV/Hib and OPV vaccines within 14 days before each dose of HRV vaccine and ending 14 days after.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Household contact with an immunosuppressed individual or pregnant women.
Previous confirmed occurrence of RV GE.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00363545

Locations

Panama
GSK Investigational Site
Panama, Panama
GSK Investigational Site
David, Panama
Panama, Panamá
GSK Investigational Site
Panama, Panamá, Panama
GSK Investigational Site
La Chorrera, Panamá, Panama

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	107077
Study First Received:	August 11, 2006
Last Updated:	October 15, 2008
ClinicalTrials.gov Identifier:	NCT00363545 History of Changes
Health Authority:	Panama: Ministry of Health

Keywords provided by GlaxoSmithKline:

Prophylaxis against gastroenteritis caused by Rotavirus

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

Additional relevant MeSH terms:

Digestive System Diseases
Gastrointestinal Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 02, 2009