Special Drug Use Investigation (SDUI) for Rotarix®
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.
|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)|
- 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 ]
|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)|
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.
This is non-interventional study conducted in one group received Oral Rotarix®.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01636739
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|