NCT01636739

Brief Summary

This study aims to determine the incidence of intussusceptions (IS) (including suspected cases of intussusception) after vaccination with Oral Rotarix® under clinical practice, in Japan.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10,982

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 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

July 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 10, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 2, 2015

Status Verified

October 1, 2015

Enrollment Period

3.1 years

First QC Date

July 5, 2012

Last Update Submit

October 29, 2015

Conditions

Infections, Rotavirus

Keywords

IntussusceptionsSpecial Drug Use InvestigationRotavirus

Outcome Measures

Primary Outcomes (2)

  • Determination of the incidence of IS

    During the 31-day (Day 0 -Day 30) observation period after each vaccination

  • Determination of the incidence of IS

    On the 1 year birthday of the subject

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

Additional information on intussusception will be collected through interview and by phone-contact.

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.

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 drug use investigation of Oral Rotarix will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rotavirus InfectionsIntussusception

Interventions

RIX4414 vaccineData Collection

Condition Hierarchy (Ancestors)

Reoviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsIntestinal ObstructionIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

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

July 5, 2012

First Posted

July 10, 2012

Study Start

July 1, 2012

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 2, 2015

Record last verified: 2015-10