V260 Registration Study (V260-013)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00166517
First received: September 9, 2005
Last updated: May 1, 2014
Last verified: May 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of V260 in Healthy Infants in Korea

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]

    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

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 9, 2005
Results First Received: July 6, 2009
Last Updated: May 1, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

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

ClinicalTrials.gov processed this record on July 20, 2014