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: November 1, 2013
Last verified: November 2013
  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
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:
No publications provided

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: November 1, 2013
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 April 14, 2014