Drug Use Investigation (DUI) of Rotarix®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01636193
First received: June 25, 2012
Last updated: July 25, 2013
Last verified: July 2013

June 25, 2012
July 25, 2013
June 2012
March 2016   (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. ] [ Designated as safety issue: No ]
  • Occurrence of typical symptoms of intussusceptions and bloody stool. [ Time Frame: During the 31-day observation period after each vaccination. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01636193 on ClinicalTrials.gov Archive Site
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Drug Use Investigation (DUI) of Rotarix®
Drug Use Investigation for Oral Rotarix® (Safety Investigation of Vaccination for Rotavirus Gastroenteritis)

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.

Rotavirus Vaccines
  • 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.
 
Active, not recruiting
1500
March 2016
March 2016   (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.

Both
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Yes
Contact information is only displayed when the study is recruiting subjects
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NCT01636193
115926
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP