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Drug Use Investigation for ROTARIX®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636193
First Posted: July 10, 2012
Last Update Posted: August 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
June 25, 2012
July 10, 2012
August 17, 2015
June 2012
September 2014   (Final data collection date for primary outcome measure)
  • 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. ]
Same as current
Complete list of historical versions of study NCT01636193 on ClinicalTrials.gov Archive Site
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Drug Use Investigation for ROTARIX®
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.
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).
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis as part of routine immunisation programme.
Infections, Rotavirus
  • Biological: Oral Rotarix®
    2 doses administered orally.
  • Other: Data collection
    Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.
Rota Group
Subjects will receive Rotarix® as per routine practice.
Interventions:
  • Biological: Oral Rotarix®
  • Other: Data collection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1607
September 2014
September 2014   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
Child, Adult, Senior
Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01636193
115926
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GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
August 2015