Consistency Lots Vaccine Study - Full Text View

Purpose

This study was designed to evaluate consistency in the antibody response to three manufactured lots of an investigational Rotavirus Vaccine.

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

MedlinePlus related topics:

Rotavirus Infections

ChemIDplus related topics:

RotaTeq

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety Study

Official Title:	Comparison of the Immunogenicity and Safety of Three Consistency Lots of V260 in Healthy Infants

Further study details as provided by Merck:

Primary Outcome Measures:

Serum neutralizing antibodies (SNA) against rotavirus; Risk of intussusception within 42 days following any dose [ Time Frame: 42 days following any dose ] [ Designated as safety issue: No ]

Intervention Details:

Duration of Treatment: 1 year

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
Known or suspected problems with the immune system
Fever at time of immunization
Prior administration of a rotavirus vaccine
History of known prior rotavirus disease, chronic diarrhea, or failure to thrive.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092456

Sponsors and Collaborators

Merck

Investigators


Study Director:	Medical Monitor	Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2004_078, V260-009
First Received:	September 22, 2004
Last Updated:	July 31, 2008
ClinicalTrials.gov Identifier:	NCT00092456
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Virus Diseases

Rotavirus Infections

Healthy

Additional relevant MeSH terms:

RNA Virus Infections

Reoviridae Infections

Infection

ClinicalTrials.gov processed this record on October 09, 2008

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00092456