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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:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00718237
First received: July 16, 2008
Last updated: March 22, 2013
Last verified: March 2013
History of Changes

July 16, 2008
March 22, 2013
August 2008
August 2009   (final data collection date for primary outcome measure)
Efficacy Against Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1 [ Time Frame: At least 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]

Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition.

Vaccine Efficacy is defined as: 1-Relative Risk (RR), expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.
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) ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00718237 on ClinicalTrials.gov Archive Site
  • Efficacy Against 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 ] [ Designated as safety issue: No ]

    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition Vaccine Efficacy is defined as: 1-Relative Risk (RR), expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.

    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.

  • Efficacy Against 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 ] [ Designated as safety issue: No ]

    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition Vaccine Efficacy is defined as: 1-Relative Risk (RR), expressed as a percentage; the RR is the incidence in the vaccine group / the incidence in the placebo group.

    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) ] [ Designated as safety issue: No ]
  • Occurrence of Rotavirus Gastroenteritis of Any Severity Caused by Rotavirus Serotypes G1, G2, G3, G4 and G-serotypes Associated With Serotype P1 [ Time Frame: At least 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    Any severity cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 occurring at least 14 days postdose 3 in the per-protocol population using per-protocol case definition.
  • Occurrence of Moderate to Severe Rotavirus Gastroenteritis Caused by Rotavirus Serotypes G1, G2, G3, G4 and Gserotypes Associated With Serotype P1A. [ Time Frame: At least 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]

    Moderate to severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 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.

  • Occurrence of 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 ] [ Designated as safety issue: No ]

    Severe cases of rotavirus gastroenteritis caused by G1, G2, G3, G4 or G-serotypes associated with serotype P1 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.
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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)
Not Provided

*   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
Both
6 Weeks to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00718237
2008_014, V260-029
Not Provided
Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
March 2013

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