Special Drug Use Investigation for ROTARIX®

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.

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Key information

Conditions

Infections, Rotavirus Digestive System Diseases Gastrointestinal Diseases Infections Intestinal Diseases Intestinal Obstruction Intussusception RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Sex eligibility

All sexes

Study type

Observational

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Oral Rotarix®

Biological

2 doses administered orally.

Data Collection

Other

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

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Special Drug Use Investigation for ROTARIX

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Jul 10, 2012
Registry last updated: Nov 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed