Last updated: 11/07/2018 09:59:13

Drug Use Investigation for ROTARIX®

GSK study ID
115926
See study documents
Clinicaltrials.gov ID
NCT01636193
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: Drug Use Investigation for ROTARIX
Trial description: This study aims to assess the safety of Oral Rotarix® under clinical practice; and collect information regarding typical symptoms of intussusceptions and bloody stool in Japan.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of Adverse events under clinical practice.

Timeframe: During the 31-day observation period after each vaccination.

Occurrence of typical symptoms of intussusceptions and bloody stool.

Timeframe: During the 31-day observation period after each vaccination.

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Oral Rotarix®
  • Other: Data collection
    • Enrollment:
    1607
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Kimura T et al. (2015) Safety of live attenuated human rotavirus vaccine, oral, ROTARIX® liquid formulation in clinical practice: Findings from drug use investigation. Prog Med. 35(3):577-584.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    June 2012 to September 2014
    Type
    Observational
    Phase
    Not applicable

    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 special 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 special 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)

    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
    Not applicable
    Actual study completion date
    2014-02-09

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
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