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OpenTrials
Completed

NCT Number: NCT01636193

Drug Use Investigation for ROTARIX®

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.

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Key information

Conditions

Infections, Rotavirus Infections 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®. This surveillance is abbreviated as SMILER (Surveillance and Monitoring In Living clinical Experience for 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 special drug use investigation of Oral Rotarix will be excluded.

Treatment and study plan

Oral Rotarix®

Biological

2 doses administered orally.

Data Collection

Other

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

Primary outcomes

  1. Occurrence of Adverse events under clinical practice.

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

  2. Occurrence of typical symptoms of intussusceptions and bloody stool.

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

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Drug Use Investigation for ROTARIX

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 10, 2012
Registry last updated
Aug 17, 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.

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