We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00362648
Recruitment Status : Completed
First Posted : August 10, 2006
Results First Posted : May 13, 2010
Last Update Posted : April 13, 2017
Sponsor:
Information provided by (Responsible Party):

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

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7504 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Efficacy, Safety, and Immunogenicity of RotaTeq™ Among Infants in Asia and Africa
Study Start Date : March 2007
Primary Completion Date : March 2009
Study Completion Date : March 2009
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)

  2. 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 ]
    Induction of postdose 3 SNA response (Number of subjects with ≥ 3 fold rise in antibody titer)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 12 Weeks   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00362648


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00362648     History of Changes
Other Study ID Numbers: V260-015
2006_027
First Posted: August 10, 2006    Key Record Dates
Results First Posted: May 13, 2010
Last Update Posted: April 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
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


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