Special Drug Use Investigation for ROTARIX®

Special Drug Use Investigation for ROTARIX

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01636739

Enrollment

10982

Registered

2012-07-10

Start date

2012-07-31

Completion date

2015-08-31

Last updated

2015-11-02

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

Conditions

Infections, Rotavirus

Keywords

Intussusceptions, Special Drug Use Investigation, Rotavirus

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.

Detailed description

This is non-interventional study conducted in one group received Oral Rotarix®.

Interventions

BIOLOGICALOral Rotarix®

2 doses administered orally.

OTHERData collection

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Determination of the incidence of IS	During the 31-day (Day 0 -Day 30) observation period after each vaccination

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026