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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: October 30, 2014
Last verified: October 2014

September 9, 2005
October 30, 2014
August 2005
July 2006   (final data collection date for primary outcome measure)
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

immunogenicity
Complete list of historical versions of study NCT00166517 on ClinicalTrials.gov Archive Site
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

Safety
Not Provided
Not Provided
 
V260 Registration Study (V260-013)(COMPLETED)
Immunogenicity and Safety of V260 in Healthy Infants in Korea

Immunogenicity and Safety of V260 in Healthy Infants in Korea

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Rotavirus
  • 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
  • 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
  • Experimental: 1
    RotaTeq
    Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Comparator: Placebo
Kim DS, Lee TJ, Kang JH, Kim JH, Lee JH, Ma SH, Kim SY, Kim HM, Shin SM. Immunogenicity and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine in healthy infants in Korea. Pediatr Infect Dis J. 2008 Feb;27(2):177-8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
178
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00166517
V260-013, 2005_071
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP