Developing World Study for RotaTeq™ - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00362648

Purpose

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Condition	Intervention	Phase
Vomiting Diarrhea Fever	Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Placebo	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Fever

Drug Information available for: RotaTeq

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

Severe gastroenteritis caused by any rotavirus serotype. [ Time Frame: 20 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety/tolerability, anti-rotavirus IgA [ Time Frame: 20 Months ] [ Designated as safety issue: Yes ]

Enrollment:	7504
Study Start Date:	March 2007
Study Completion Date:	March 2009
Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental RotaTeq™	Biological: Rotavirus Vaccine, Live, Oral, Pentavalent 5.5 ml oral dose of RotaTeq™. 14 week treatment period
2: Placebo Comparator Placebo	Biological: Comparator: Placebo Arm 2: Placebo. 14 week treatment period

Eligibility

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

Criteria

Inclusion Criteria:

Age 4 weeks through 12 weeks at Dose 1
Parent able to understand study procedures and give consent

Exclusion Criteria:

Clinical evidence of active gastrointestinal disease
Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362648

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

PhRMA Clinical Study Results Database - web-based repository for clinical study results This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2006_027, V260-015
Study First Received:	August 8, 2006
Last Updated:	June 5, 2009
ClinicalTrials.gov Identifier:	NCT00362648 History of Changes
Health Authority:	Ghana: Ministry of Health

Study placed in the following topic categories:

Fever
Vomiting
Diarrhea

ClinicalTrials.gov processed this record on September 02, 2009