Back to resultsDose Confirmation Efficacy Study (V260-007)
Primary Purpose
Rotavirus Infections
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Comparator: Placebo matching RotaTeq™
Sponsored by
About this trial
This is an interventional prevention trial for Rotavirus Infections
Eligibility Criteria
Inclusion Criteria: Healthy infants Exclusion Criteria: History of abdominal disorders from a birth defect, intussusception, or abdominal surgery Known or suspected problems with immune system Fever at time of immunization Prior administration of a rotavirus vaccine History of known prior rotavirus disease Chronic diarrhea, or failure to thrive
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Placebo matching RotaTeq™
Arm Description
Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart.
Placebo matching RotaTeq™ administered 28 to 70 days apart.
Outcomes
Primary Outcome Measures
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
Secondary Outcome Measures
Number of Subjects With ≥3 Fold Rise in Antibody Titer
Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)
Full Information
NCT ID
NCT00092443
First Posted
September 22, 2004
Last Updated
September 11, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00092443
Brief Title
Dose Confirmation Efficacy Study (V260-007)
Official Title
Study of the Efficacy, Safety, and Immunogenicity of V260 at Expiry
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
5. Study Description
Brief Summary
This study was designed to evaluate the safety of the investigational Rotavirus Vaccine and the efficacy to prevent Rotavirus Gastroenteritis.
Detailed Description
The duration of treatment is 10 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotavirus Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1312 (Actual)
8. Arms, Groups, and Interventions
Arm Title
RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)
Arm Type
Experimental
Arm Description
Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent)
administered 28 to 70 days apart.
Arm Title
Placebo matching RotaTeq™
Arm Type
Placebo Comparator
Arm Description
Placebo matching RotaTeq™ administered 28 to 70 days apart.
Intervention Type
Biological
Intervention Name(s)
RotaTeq™, rotavirus vaccine, live, oral, pentavalent
Other Intervention Name(s)
V260
Intervention Description
Three doses of RotaTeq™ administered 28 to 70 days apart.
Intervention Type
Biological
Intervention Name(s)
Comparator: Placebo matching RotaTeq™
Intervention Description
Placebo matching RotaTeq™ administered 28 to 70 days apart.
Primary Outcome Measure Information:
Title
Occurence of Clinical Rotavirus Disease Caused by the Composite of the Serotypes Contained Within the Vaccine More Than 14 Days Following the Third Dose.
Description
G1, G2, G3, and G4 Serotype Rotavirus Gastroenteritis Cases Occurring at Least 14 Days Postdose 3 Through the First Rotavirus Season Postvaccination in the Per-Protocol Population Using Per-Protocol Case Definition
Time Frame
At least 14 days following the 3rd vaccination
Secondary Outcome Measure Information:
Title
Number of Subjects With ≥3 Fold Rise in Antibody Titer
Description
Induction of postdose 3 rotavirus Serum neutralizing antibody (SNA) response (Number of subjects with ≥3 fold rise in antibody titer)
Time Frame
14 days following the 3rd vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy infants
Exclusion Criteria:
History of abdominal disorders from a birth defect, intussusception, or abdominal surgery
Known or suspected problems with immune system
Fever at time of immunization
Prior administration of a rotavirus vaccine
History of known prior rotavirus disease
Chronic diarrhea, or failure to thrive
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
17200266
Citation
Block SL, Vesikari T, Goveia MG, Rivers SB, Adeyi BA, Dallas MJ, Bauder J, Boslego JW, Heaton PM; Pentavalent Rotavirus Vaccine Dose Confirmation Efficacy Study Group. Efficacy, immunogenicity, and safety of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine at the end of shelf life. Pediatrics. 2007 Jan;119(1):11-8. doi: 10.1542/peds.2006-2058.
Results Reference
background
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Dose Confirmation Efficacy Study (V260-007)
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