NCT01357174

Brief Summary

This study will collect demographic and safety information on the use of ROTATEQ™ in the Philippines.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
915

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 20, 2011

Completed
Last Updated

October 30, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

May 18, 2011

Last Update Submit

October 29, 2015

Conditions

Rotavirus InfectionsGastroenteritis

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events following administration of ROTATEQ™

    Three-year period following vaccine marketing approval (August 2007 to August 2010)

Study Arms (1)

All Participants

Infants who were vaccinated with ROTATEQ™

Eligibility Criteria

Age6 Weeks - 12 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Infants in the Philippines who received ROTATEQ.™ Information will be provided by the physicians who administered the vaccine.

You may qualify if:

  • Received ROTATEQ™

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotavirus InfectionsGastroenteritis

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2011

First Posted

May 20, 2011

Study Start

October 1, 2007

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

October 30, 2015

Record last verified: 2015-10