Special Drug Use Investigation for ROTARIX®

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01636739
• Collaborator: (none)
• Enrollment: 10,982
• Duration (Months): 37

Study Details

Study Description

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	Phase
Infections, Rotavirus	Biological: Oral Rotarix®; Other: Data collection

Detailed Description

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

Study Design

• Study Type: Observational
• Actual Enrollment: 10982 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Special Drug Use Investigation for ROTARIX
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Determination of the incidence of IS [During the 31-day (Day 0 -Day 30) observation period after each vaccination]

2. Determination of the incidence of IS [On the 1 year birthday of the subject]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

No locations specified.

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT01636739
• Other Study ID Numbers: 115927
• First Posted: Jul 10, 2012
• Last Update Posted: Nov 1, 2015
• Last Verified: Oct 1, 2015

• Keywords provided by GlaxoSmithKline: Intussusceptions; Special Drug Use Investigation; Rotavirus
• Additional relevant MeSH terms: Rotavirus Infections

Study Results

No Results Posted as of Nov 1, 2015