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Special Drug Use Investigation (SDUI) for Rotarix®

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01636739
First received: July 5, 2012
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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.


Condition Intervention
Rotavirus Gastroenteritis
Intussusceptions
 Biological: Oral Rotarix®
Other: Data collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for Rotarix® (Investigation of Incidence of Intussusception After Vaccination for Rotavirus Gastroenteritis)

Resource links provided by NLM:

MedlinePlus related topics: Gastroenteritis
Drug Information available for: Rotarix
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Determination of the incidence of IS [ Time Frame: During the 31-day (Day 0 -Day 30) observation period after each vaccination ] [ Designated as safety issue: No ]
  • Determination of the incidence of IS [ Time Frame: On the 1 year birthday of the subject ] [ Designated as safety issue: No ]

Estimated Enrollment: 10000
Study Start Date: July 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rota Group
Subjects will receive Rotarix® as per routine practice
 Biological: Oral Rotarix®
2 doses administered orally.
Other: Data collection
Additional information on intussusception will be collected through interview and by phone-contact.

Detailed Description:

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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636739

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636739     History of Changes
Other Study ID Numbers: 115927
Study First Received: July 5, 2012
Last Updated: February 21, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Intussusceptions
Special Drug Use Investigation
Rotavirus

Additional relevant MeSH terms:
Gastroenteritis
Intussusception
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Obstruction
Intestinal Diseases

ClinicalTrials.gov processed this record on May 16, 2013