Drug Use Investigation for ROTARIX®

Drug Use Investigation for ROTARIX

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01636193

Enrollment

1607

Registered

2012-07-10

Start date

2012-06-30

Completion date

2014-09-30

Last updated

2015-08-17

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

Conditions

Infections, Rotavirus

Keywords

Rotavirus, Rotarix, Drug Use Investigation, Safety

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.

Detailed description

This is non-interventional study conducted in one group received Oral Rotarix®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for Rotarix).

Interventions

BIOLOGICALOral Rotarix®

2 doses administered orally.

OTHERData collection

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

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 special drug use investigation of Oral Rotarix will be excluded.

Design outcomes

Primary

Measure	Time frame
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.

Outcome results

None listed

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