We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

ROTATEQ™ Post-Marketing Surveillance in the Philippines

This study has been terminated.
(Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01357174
First Posted: May 20, 2011
Last Update Posted: October 30, 2015
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Condition
Rotavirus Infections Gastroenteritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Protocol for ROTATEQ™ Post-Marketing Surveillance

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Number of participants with adverse events following administration of ROTATEQ™ [ Time Frame: Three-year period following vaccine marketing approval (August 2007 to August 2010) ]

Enrollment: 915
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
All Participants
Infants who were vaccinated with ROTATEQ™

  Eligibility

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:   6 Weeks to 12 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Infants in the Philippines who received ROTATEQ.™ Information will be provided by the physicians who administered the vaccine.
Criteria

Inclusion Criteria:

  • Received ROTATEQ™
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357174     History of Changes
Other Study ID Numbers: V260-046
First Submitted: May 18, 2011
First Posted: May 20, 2011
Last Update Posted: October 30, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases