Special Drug Use Investigation for ROTARIX®

GlaxoSmithKline10,982 enrolled

Overview

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.

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

Study Type

OBSERVATIONAL

Enrollment

10,982

Conditions

Infections, Rotavirus

Interventions

Oral Rotarix®BIOLOGICAL

2 doses administered orally.

Data collectionOTHER

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

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 drug use investigation of Oral Rotarix will be excluded.

Outcomes

Primary Outcomes

Determination of the incidence of IS

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

Determination of the incidence of IS

Time frame: On the 1 year birthday of the subject

Data from ClinicalTrials.gov

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