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Special Drug Use Investigation for ROTARIX®

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636739
First Posted: July 10, 2012
Last Update Posted: November 2, 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
  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
Infections, Rotavirus 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

Resource links provided by NLM:


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 ]
  • Determination of the incidence of IS [ Time Frame: On the 1 year birthday of the subject ]

Enrollment: 10982
Study Start Date: July 2012
Study Completion Date: August 2015
Primary Completion Date: August 2015 (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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636739


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636739     History of Changes
Other Study ID Numbers: 115927
First Submitted: July 5, 2012
First Posted: July 10, 2012
Last Update Posted: November 2, 2015
Last Verified: October 2015

Keywords provided by GlaxoSmithKline:
Intussusceptions
Special Drug Use Investigation
Rotavirus

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases