ROTATEQ™ Post-Marketing Surveillance in the Philippines

Protocol for ROTATEQ™ Post-Marketing Surveillance

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01357174

Enrollment

915

Registered

2011-05-20

Start date

2007-10-31

Completion date

2010-09-30

Last updated

2015-10-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroenteritis, Rotavirus Infections

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Weeks to 12 Weeks

Healthy volunteers

Yes

Inclusion criteria

* Received ROTATEQ™

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events following administration of ROTATEQ™	Three-year period following vaccine marketing approval (August 2007 to August 2010)

Outcome results