- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00718237
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
March 16, 2017 updated by: Merck Sharp & Dohme LLC
A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan
The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
762
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 month to 2 months (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Healthy Japanese Infants, 6 Weeks Through 12 Weeks Of Age
Exclusion Criteria:
- History Of Known Prior Rotavirus Gastroenteritis
- Subjects Who Are Concurrently Participating In Or Are Anticipated To Participate In Other Studies Of Investigational Products At Any Time During The Study Period
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
Placebo
|
Placebo orally administered 3 times
|
Experimental: 1
RotaTeq™
|
Rotateq orally administered 3 times
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Time Frame: At least 14 days following the 3rd vaccination
|
Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition
|
At least 14 days following the 3rd vaccination
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Time Frame: At least 14 days following the 3rd vaccination
|
Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition.
Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes.
Score of >8 and <=16 was considered moderate, and >16 was considered severe.
|
At least 14 days following the 3rd vaccination
|
Number of Participants With Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1A
Time Frame: At least 14 days following the 3rd vaccination
|
Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1A occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition.
Severity score was calculated based on frequency and duration of diarrhea, vomiting, elevated temperature, and behavioral changes.
Score of >8 and <=16 was considered moderate, and >16 was considered severe.
|
At least 14 days following the 3rd vaccination
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
July 16, 2008
First Submitted That Met QC Criteria
July 16, 2008
First Posted (Estimate)
July 18, 2008
Study Record Updates
Last Update Posted (Actual)
April 13, 2017
Last Update Submitted That Met QC Criteria
March 16, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- V260-029
- 2008_014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroenteritis
-
GlaxoSmithKlineCompletedRotavirus Gastroenteritis | Nosocomial Rotavirus Gastroenteritis
-
University Hospital for Infectious Diseases, CroatiaCompletedRotavirus GastroenteritisCroatia
-
National Institute of Allergy and Infectious Diseases...CompletedGastroenteritis NorovirusUnited States
-
Merck Sharp & Dohme LLCCompleted
-
MSD Wellcome Trust Hilleman Laboratories Pvt. Ltd.ParexelCompletedRotavirus GastroenteritisBangladesh
-
PATHCenters for Disease Control and Prevention; Noguchi Memorial Institute for... and other collaboratorsCompletedRotavirus GastroenteritisGhana
-
GlaxoSmithKlineCompletedRotavirus GastroenteritisGreece
-
Shantha Biotechnics LimitedCompletedRotavirus GastroenteritisIndia
-
Shantha Biotechnics LimitedUnknownRotavirus GastroenteritisIndia
-
National Institute of Allergy and Infectious Diseases...Completed
Clinical Trials on Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
-
Merck Sharp & Dohme LLCCompletedVomiting | Diarrhea | Fever
-
Merck Sharp & Dohme LLCCompletedRotavirus Gastroenteritis
-
Merck Sharp & Dohme LLCCompletedGastroenteritis | Rotavirus
-
Merck Sharp & Dohme LLCWithdrawnPertussis | Tetanus | Diphtheria | Rotavirus Gastroenteritis
-
Children's Hospital of MichiganMerck Sharp & Dohme LLC; Boston Children's Hospital; William Beaumont HospitalsCompletedShort Bowel SyndromeUnited States
-
Dennis ClementsMerck Sharp & Dohme LLCCompletedGastroenteritis | DiarrheaUnited States
-
Merck Sharp & Dohme LLCCompleted