Safety,Tolerability and Immunogenicity of Vaccination With Rotateq in Healthy Infants in India - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00496054

Purpose

To observe the safety, tolerability and immunogenicity of the administration of 3 doses of rotateq in healthy Indian infants between 6 weeks through exactly 12 weeks of age at entry.

Condition	Intervention	Phase
Gastroenteritis Rotavirus	Biological: rotavirus vaccine, live, oral, pentavalent	Phase III

MedlinePlus related topics: Gastroenteritis

Drug Information available for: RotaTeq

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Safety,Tolerability and Immunogenicity of Vaccination With Rotateq (V260) in Healthy Infants in India

Further study details as provided by Merck:

Primary Outcome Measures:

The proportion of subjects who exhibit a 3 fold rise or greater from baseline to postdose 3 in rotavirus specific serum in iga will be summarized. [ Time Frame: Approximately 110 Days ] [ Designated as safety issue: No ]
The 3 fold rise responses to g1, g2, g3, g4 & p1 serum neutralizing antibodies(sna) will also be summarized. gmt at predose 1 & postdose 3 will also be summarized for all assays [ Time Frame: Approximately 110 Days ] [ Designated as safety issue: No ]

Estimated Enrollment:	110
Study Start Date:	May 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Pentavalent vaccine 9G1, G2, G3, G4 & P1) given 3 times. Dose 1 will be administered at study entry; Dose 2 will be administered 4 to 10 weeks (28 to 70 days) after Dose 1; and Dose 3 will be administered 4 to 10 weeks (28 to 70 days) after Dose 2.

Eligibility

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

Criteria

Inclusion Criteria:

Age 6 weeks through exactly 12 weeks
Healthy infants

Exclusion Criteria:

Clinical evidence of active gastrointestinal illness
Fever, with a rectal temperature of greater than and equal to thirty eight degree celsius at the time of immunization
History of congenital abdominal disorders, intussusception, or abdominal surgery
History of known prior rotavirus disease
Known or suspected impairment of immunological function
Ongoing chronic diarrhea or failure to thrive
Prior administration of any rotavirus vaccine
Known hypersensitivity to any component of the rotavirus vaccine, e.g. trypsin

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496054

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More 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

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_020, V260-021
Study First Received:	July 3, 2007
Last Updated:	October 6, 2008
ClinicalTrials.gov Identifier:	NCT00496054
Health Authority:	India: Indian Council of Medical Research

Study placed in the following topic categories:

Digestive System Diseases
Gastrointestinal Diseases
Healthy
Gastroenteritis

ClinicalTrials.gov processed this record on January 16, 2009