NCT01636193

Brief Summary

This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,607

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2012

Typical duration for all trials

Status
completed

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

June 1, 2012

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

August 17, 2015

Status Verified

August 1, 2015

Enrollment Period

2.3 years

First QC Date

June 25, 2012

Last Update Submit

August 13, 2015

Conditions

Infections, Rotavirus

Keywords

RotavirusRotarixDrug Use InvestigationSafety

Outcome Measures

Primary Outcomes (2)

  • Occurrence of Adverse events under clinical practice.

    During the 31-day observation period after each vaccination.

  • Occurrence of typical symptoms of intussusceptions and bloody stool.

    During the 31-day observation period after each vaccination.

Study Arms (1)

Rota Group

Subjects will receive Rotarix® as per routine practice.

Biological: Oral Rotarix®Other: Data collection

Interventions

Oral Rotarix®BIOLOGICAL

2 doses administered orally.

Rota Group
Data collectionOTHER

Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.

Rota Group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.

You may qualify if:

  • Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.

You may not qualify if:

  • All infants included in the special drug use investigation of Oral Rotarix will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotavirus Infections

Interventions

RIX4414 vaccineData Collection

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfections

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 10, 2012

Study Start

June 1, 2012

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

August 17, 2015

Record last verified: 2015-08