ROTATEQ™ Post-Marketing Surveillance in the Philippines | NCT01357174

Studies
ROTATEQ™ Post-Marketing Surveillance in the Philippines

NCT01357174

Sponsor

Merck Sharp & Dohme LLC

Status

Terminated

Last Update Posted

Oct 30, 2015Estimated

Enrollment

915Actual

Phase

Not provided

Conditions

Rotavirus Infections
Gastroenteritis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Merck Sharp & Dohme Corp (MSD) received exemption from PFDA on conduct of post-marketing surveillance (PMS) study

Expanded Access Info

Start Date

Oct 2007

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

May 18, 2011

First Submission Date that Met QC Criteria

May 18, 2011

First Posted Date

May 20, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 29, 2015

Last Update Posted Date

Oct 30, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

915Actual

Label	Type	Description	Intervention Names
All Participants		Infants who were vaccinated with ROTATEQ™

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Received ROTATEQ™

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Weeks

Maximum Age

12 Weeks

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D012400	Rotavirus Infections
D005759	Gastroenteritis

Ancestor Terms

ID	Term
D012088	Reoviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided