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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:
Merck
ClinicalTrials.gov Identifier:
NCT01357174
First received: May 18, 2011
Last updated: NA
Last verified: May 2011
History: No changes posted
  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:

Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by Merck:

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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, 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: May 18, 2011
Health Authority: Philippines: Bureau of Food and Drugs

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

ClinicalTrials.gov processed this record on May 19, 2013