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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01357174
First received: May 18, 2011
Last updated: September 6, 2013
Last verified: September 2013
  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

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)
Groups/Cohorts
All Participants
Infants who were vaccinated with ROTATEQ™

  Eligibility

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.

Criteria

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357174     History of Changes
Other Study ID Numbers: V260-046
Study First Received: May 18, 2011
Last Updated: September 6, 2013
Health Authority: Philippines: Bureau of Food and Drugs

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

ClinicalTrials.gov processed this record on October 22, 2014