Last updated: 06/28/2019 09:20:14

Special Drug Use Investigation for ROTARIX®

GSK study ID
115927
See study documents
Clinicaltrials.gov ID
NCT01636739
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Special Drug Use Investigation for ROTARIX
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Determination of the incidence of IS

Timeframe: During the 31-day (Day 0 –Day 30) observation period after each vaccination

Determination of the incidence of IS

Timeframe: On the 1 year birthday of the subject

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Oral Rotarix®
  • Other: Data collection
    • Enrollment:
    10982
    Primary completion date:
    2015-31-08
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Yanagita Y et al. (2016) Investigation of the Occurrence of Intussusception after Administration of Oral Live Attenuated Human Vaccine (Rotarix®): Results from Special Drug Use Investigation. Prog Med. 36(8):1121-1125.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    July 2012 to August 2015
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable
    Accepts healthy volunteers
    Yes
    • Infants who receive Rotarix for the first time to prevent rotavirus gastroenteritis, an indication of Rotarix, will be included in the investigation.
    • All infants included in the drug use investigation of Oral Rotarix will be excluded.
    Inclusion and exclusion 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.

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2015-31-08
    Actual study completion date
    2015-31-08

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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