Text Size

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
  Purpose

The purpose of the study is to evaluate whether V260 is effective and well tolerated in Japanese healthy infants.


Condition Intervention Phase
Rotavirus
Gastroenteritis
 Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Biological: Comparator: Comparator: Placebo (unspecified)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III Randomized, Placebo-controlled Clinical Trial to Study the Efficacy and Safety of V260 in Healthy Infants in Japan

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.



Other Outcome Measures:
  • 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.



Enrollment: 762
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RotaTeq™
 Biological: Rotavirus Vaccine, Live, Oral, Pentavalent (V260, RotaTeq™)
Rotateq orally administered 3 times
Other Names:
  • RotaTeq™
  • V260
Placebo Comparator: 2
Placebo
 Biological: Comparator: Comparator: Placebo (unspecified)
Placebo orally administered 3 times

  Eligibility

Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718237

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Additional Information:
MedWatch - FDA maintained medical product safety Information  This link exits the ClinicalTrials.gov site
Merck: Patient & Caregiver U.S. Product Web Site  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00718237     History of Changes
Other Study ID Numbers: 2008_014, V260-029
Study First Received: July 16, 2008
Results First Received: June 23, 2010
Last Updated: March 22, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Merck:
Gastroenteritis
Rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013