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ROTATEQ™ Post-Marketing Surveillance in the Philippines

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ClinicalTrials.gov Identifier: NCT01357174
Recruitment Status : Terminated (Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study)
First Posted : May 20, 2011
Last Update Posted : October 30, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Condition or disease
Rotavirus Infections Gastroenteritis

Study Design

Study Type : Observational
Actual Enrollment : 915 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Protocol for ROTATEQ™ Post-Marketing Surveillance
Study Start Date : October 2007
Primary Completion Date : September 2010
Study Completion Date : September 2010
Groups and Cohorts

Group/Cohort
All Participants
Infants who were vaccinated with ROTATEQ™


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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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™
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357174     History of Changes
Other Study ID Numbers: V260-046
First Posted: May 20, 2011    Key Record Dates
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