We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dose Confirmation Efficacy Study (V260-007)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00092443
First Posted: September 27, 2004
Last Update Posted: September 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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 ]
    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: June 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: September 22, 2004
First Posted: September 27, 2004
Results First Submitted: May 19, 2009
Results First Posted: July 10, 2009
Last Update Posted: September 14, 2015
Last Verified: September 2015

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs