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Special Drug Use Investigation for ROTARIX®

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ClinicalTrials.gov Identifier: NCT01636739
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : November 2, 2015
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:
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 or disease Intervention/treatment
Infections, Rotavirus Biological: Oral Rotarix® Other: Data collection

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

Study Type : Observational
Actual Enrollment : 10982 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Special Drug Use Investigation for ROTARIX
Study Start Date : July 2012
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.



Primary Outcome Measures :
  1. Determination of the incidence of IS [ Time Frame: During the 31-day (Day 0 -Day 30) observation period after each vaccination ]
  2. Determination of the incidence of IS [ Time Frame: On the 1 year birthday of the subject ]


Information from the National Library of Medicine

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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.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01636739     History of Changes
Other Study ID Numbers: 115927
First Posted: July 10, 2012    Key Record Dates
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