Drug Use Investigation for ROTARIX®

GlaxoSmithKline1,607 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

1,607

Conditions

Infections, Rotavirus

Interventions

Oral Rotarix®BIOLOGICAL

2 doses administered orally.

Data collectionOTHER

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

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Occurrence of Adverse events under clinical practice.

Time frame: During the 31-day observation period after each vaccination.

Occurrence of typical symptoms of intussusceptions and bloody stool.

Time frame: During the 31-day observation period after each vaccination.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.