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: April 17, 2014
Last verified: April 2014
  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® (Investigation of Incidence of Intussusception After Vaccination for Rotavirus Gastroenteritis)

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: April 2017
Estimated Primary Completion Date: April 2017 (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
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, see Learn About Clinical Studies.

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: April 17, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by GlaxoSmithKline:
Intussusceptions
Special Drug Use Investigation
Rotavirus

Additional relevant MeSH terms:
Intussusception
Rotavirus Infections
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 28, 2014