Developing World Study for RotaTeq™ (V260-015)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00362648
First received: August 8, 2006
Last updated: November 4, 2013
Last verified: November 2013

August 8, 2006
November 4, 2013
March 2007
March 2009   (final data collection date for primary outcome measure)
Occurrence of Severe Clinical Rotavirus Disease Caused by Any Rotavirus Serotype More Than 14 Days Following the Third Dose [ Time Frame: At least 14 days following the third vaccination ] [ Designated as safety issue: No ]
Severe gastroenteritis caused by any rotavirus serotype
Complete list of historical versions of study NCT00362648 on ClinicalTrials.gov Archive Site
  • Africa - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 14 days following the 3rd vaccination ] [ Designated as safety issue: Yes ]
    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
  • Asia - Serum Anti-rotavirus IgA Responses and Serum Neutralizing Antibody (SNA) Responses Against Rotavirus Serotypes G1, G2, G3, G4, and P1A[8] [ Time Frame: 14 days following the 3rd vaccination ] [ Designated as safety issue: No ]
    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)
Safety/tolerability, anti-rotavirus IgA
Not Provided
Not Provided
 
Developing World Study for RotaTeq™ (V260-015)(COMPLETED)
Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

The purpose of the current study is to evaluate whether the vaccine is effective, well-tolerated and immunogenic among infants in developing countries.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Vomiting
  • Diarrhea
  • Fever
  • Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
    2.0 mL oral dose of RotaTeq™. 14 week treatment period
    Other Names:
    • RotaTeq™
    • V260
  • Biological: Comparator: Placebo
    Arm 2: Placebo. 14 week treatment period
  • Experimental: 1
    RotaTeq™
    Intervention: Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
  • Placebo Comparator: 2
    Placebo
    Intervention: Biological: Comparator: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7504
March 2009
March 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 4 weeks through 12 weeks at Dose 1
  • Parent able to understand study procedures and give consent

Exclusion Criteria:

  • Clinical evidence of active gastrointestinal disease
  • Subjects who are currently or expected to participate in other studies of investigational products during the 6 weeks after receiving the last dose of RotaTeq™/placebo
Both
up to 12 Weeks
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00362648
V260-015, 2006_027
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

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