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Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00718237
First Posted: July 18, 2008
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
July 16, 2008
July 18, 2008
June 23, 2010
July 23, 2010
April 13, 2017
August 2008
August 2009   (Final data collection date for primary outcome measure)
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
Efficacy Against Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1 [ Time Frame: 25 Month(s) ]
Complete list of historical versions of study NCT00718237 on ClinicalTrials.gov Archive Site
  • 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.
  • 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.
1)Safety, 2)Efficacy against moderate to severe and severe rotavirus gastroenteritis caused by rotavirus serotypes G1, G2, G3, G4 and G-serotypes associated with serotype P1A [ Time Frame: 25 Month(s) ]
Not Provided
Not Provided
 
Phase III Placebo-controlled Study of V260 (RotaTeq™) in Japanese Healthy Infants (V260-029)(COMPLETED)
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
  • Rotavirus
  • Gastroenteritis
  • Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
    Rotateq orally administered 3 times
    Other Names:
    • RotaTeq™
    • V260
  • Biological: Comparator: Comparator: Placebo (unspecified)
    Placebo orally administered 3 times
  • Experimental: 1
    RotaTeq™
    Intervention: Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Comparator: Comparator: Placebo (unspecified)
Iwata S, Nakata S, Ukae S, Koizumi Y, Morita Y, Kuroki H, Tanaka Y, Shizuya T, Schödel F, Brown ML, Lawrence J. Efficacy and safety of pentavalent rotavirus vaccine in Japan: a randomized, double-blind, placebo-controlled, multicenter trial. Hum Vaccin Immunother. 2013 Aug;9(8):1626-33. doi: 10.4161/hv.24846. Epub 2013 May 31.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
762
August 2009
August 2009   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
6 Weeks to 12 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT00718237
V260-029
2008_014
Not Provided
Not Provided
Plan to Share IPD: Yes
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
March 2017

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