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)
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: May 18, 2011
Last updated: October 29, 2015
Last verified: October 2015
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Rotavirus Infections

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

Resource links provided by NLM:

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) ] [ Designated as safety issue: Yes ]

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)
All Participants
Infants who were vaccinated with ROTATEQ™


Ages Eligible for Study:   6 Weeks to 12 Weeks
Genders Eligible for Study:   Both
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.

Inclusion Criteria:

  • Received ROTATEQ™
  Contacts and Locations
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, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT01357174     History of Changes
Other Study ID Numbers: V260-046 
Study First Received: May 18, 2011
Last Updated: October 29, 2015
Health Authority: Philippines: Bureau of Food and Drugs

Additional relevant MeSH terms:
Rotavirus Infections
Digestive System Diseases
Gastrointestinal Diseases
RNA Virus Infections
Reoviridae Infections
Virus Diseases processed this record on May 26, 2016