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V260 Registration Study (V260-013)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00166517
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : September 23, 2009
Last Update Posted : April 1, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
Immunogenicity and Safety of V260 in Healthy Infants in Korea

Condition or disease Intervention/treatment Phase
Rotavirus Biological: Rotavirus Vaccine, Live, Oral, Pentavalent Biological: Comparator: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 178 participants
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
Study Start Date : August 2005
Primary Completion Date : July 2006
Study Completion Date : July 2006

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 :
  1. 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




Information from the National Library of Medicine

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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

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.

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 Posted: September 14, 2005    Key Record Dates
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