Dose Confirmation Efficacy Study (V260-007)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00092443
First received: September 22, 2004
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.


Condition Intervention Phase
Rotavirus Infections
Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Biological: Comparator: Placebo matching RotaTeq™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose. [ Time Frame: At least 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition


Secondary Outcome Measures:
  • Number of Subjects With ≥3 Fold Rise in Antibody Titer [ Time Frame: 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)


Enrollment: 1312
Study Start Date: September 2002
Study Completion Date: September 2004
Primary Completion Date: June 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)

Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)

administered 28 to 70 days apart.

Biological: RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Three doses of RotaTeq™ administered 28 to 70 days apart.
Other Name: V260
Placebo Comparator: Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.
Biological: Comparator: Placebo matching RotaTeq™
Placebo matching RotaTeq™ administered 28 to 70 days apart.

Detailed Description:

The duration of treatment is 10 months.

  Eligibility

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

Inclusion Criteria:

  • Healthy infants

Exclusion Criteria:

  • History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
  • Known or suspected problems with 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: NCT00092443

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00092443     History of Changes
Other Study ID Numbers: V260-007, 2004_077
Study First Received: September 22, 2004
Results First Received: May 19, 2009
Last Updated: August 8, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 16, 2014