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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00092443
First received: September 22, 2004
Last updated: October 13, 2011
Last verified: October 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Merck
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: October 13, 2011
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 May 16, 2013