V260 Registration Study (V260-013)(COMPLETED)
Immunogenicity and Safety of V260 in Healthy Infants in Korea
2 other identifiers
interventional
178
0 countries
N/A
Brief Summary
Immunogenicity and Safety of V260 in Healthy Infants in Korea
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Aug 2005
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 9, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2006
CompletedResults Posted
Study results publicly available
September 23, 2009
CompletedApril 1, 2015
March 1, 2015
11 months
September 9, 2005
July 6, 2009
March 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Serum Anti-Rotavirus IgA Response
Number of subjects with ≥ 3-fold rise from baseline (Predose 1) in Serum IgA 14 days Postdose 3
Baseline and 14 days Postdose 3
Secondary Outcomes (1)
Serum Neutralizing Antibody (SNA) Response to Serotypes G1, G2, G3, G4 and P1A
Baseline and 14 days Postdose 3
Study Arms (2)
1
EXPERIMENTALRotaTeq
2
PLACEBO COMPARATORPlacebo
Interventions
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
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 Criteria
You may qualify if:
- At first study vaccination, age 6 weeks through exactly 12 weeks
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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. doi: 10.1097/INF.0b013e31815aba79.
PMID: 18174862RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President,Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2005
First Posted
September 14, 2005
Study Start
August 1, 2005
Primary Completion
July 1, 2006
Study Completion
July 1, 2006
Last Updated
April 1, 2015
Results First Posted
September 23, 2009
Record last verified: 2015-03