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V260 Registration Study (V260-013)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00166517
First Posted: September 14, 2005
Last Update Posted: April 1, 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
Immunogenicity and Safety of V260 in Healthy Infants in Korea

Condition Intervention Phase
Rotavirus Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of V260 in Healthy Infants in Korea

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

Primary Outcome Measures:
  • Serum Anti-Rotavirus IgA Response [ Time Frame: Baseline and 14 days Postdose 3 ]

    Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in

    Serum IgA 14 days Postdose 3



Secondary Outcome Measures:
  • Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A [ Time Frame: Baseline and 14 days Postdose 3 ]

    Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in

    SNA response to G1, G2, G3, G4 and P1A 14 days Postdose 3



Enrollment: 178
Study Start Date: August 2005
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RotaTeq
Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
Placebo Comparator: 2
Placebo
Biological: Comparator: Placebo
3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2

  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:

  • At first study vaccination, age 6 weeks through exactly 12 weeks

Exclusion Criteria:

  • History of congenital abdominal disorders, intussusception, or abdominal surgery
  • History of known prior rotavirus disease
  • Ongoing chronic diarrhea or failure to thrive
  • Clinical evidence of active gastrointestinal illness
  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): NCT00166517


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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00166517     History of Changes
Other Study ID Numbers: V260-013
2005_071
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: July 6, 2009
Results First Posted: September 23, 2009
Last Update Posted: April 1, 2015
Last Verified: March 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Gastrointestinal Rotavirus

Additional relevant MeSH terms:
Vaccines
Immunologic Factors
Physiological Effects of Drugs