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Developing World Study for RotaTeq™

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00362648
First received: August 8, 2006
Last updated: April 26, 2010
Last verified: April 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Vomiting
Diarrhea
Fever
 Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
Biological: Comparator: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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)


Enrollment: 7504
Study Start Date: March 2007
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
RotaTeq™
 Biological: RotaTeq™ - Rotavirus Vaccine, Live, Oral, Pentavalent
2.0 mL oral dose of RotaTeq™. 14 week treatment period
Other Names:
  • RotaTeq™
  • V260
Placebo Comparator: 2
Placebo
 Biological: Comparator: Placebo
Arm 2: Placebo. 14 week treatment period

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00362648

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 by Merck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00362648     History of Changes
Other Study ID Numbers: 2006_027, V260-015
Study First Received: August 8, 2006
Results First Received: March 11, 2010
Last Updated: April 26, 2010
Health Authority: Ghana: Ministry of Health

Additional relevant MeSH terms:
Diarrhea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013