Last updated: 01/21/2020 08:30:07

Evaluation of reactogenicity and safety of GSK Biologicals’ Rotarix (human rotavirus vaccine) in infants

GSK study ID
111700
See study documents
Clinicaltrials.gov ID
NCT00750893
See results summary
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: Safety of GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus vaccine, Rotarix or Rotarix liquid formulation (oral suspension or prefilled syringe) when administered according to the prescribing information in Korea
Trial description: This protocol posting deals with objectives and outcome measures of the primary phase at one month post-Dose 2. This Post Marketing Surveillance (PMS) will collect safety data on the use of human rotavirus vaccine in at least 3000 evaluable infants in Korea. This study involves male or female infants from the age of 6 weeks at the time of the first vaccination. The vaccination course must be completed by the age of 24 weeks.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of subjects reporting solicited general symptoms

Timeframe: During the 8-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

Number of subjects reporting unsolicited adverse events (AEs) during the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 & Year 2 study period

Number of subjects reporting unsolicited adverse events (AEs) during the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 3 & Year 4 study period

Number of subjects reporting unsolicited adverse events (AEs) during the 31-day follow-up period after each vaccine dose for Year 5 study period

Timeframe: During the 31 day follow-up period after each vaccine dose for Year 5 study period

Number of subjects reporting unsolicited adverse events (AEs) during the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period

Timeframe: During the 31-day follow-up period after each vaccine dose for Year 1 to Year 6 study period

Number of subjects reporting serious adverse events (SAEs) during the post-marketing study period for Year 1 & Year 2 study period

Timeframe: During the post-marketing study period for Year 1 & Year 2 study period

Number of subjects reporting serious adverse events (SAEs) during the post-marketing study period for Year 3 & Year 4 study period

Timeframe: During the post-marketing study period for Year 3 & Year 4 study period

Number of subjects reporting serious adverse events (SAEs) during the post-marketing study period for Year 5 study period

Timeframe: During the post-marketing study period for Year 5 study period

Number of subjects reporting serious adverse events (SAEs) during the post-marketing study period for Year 1 to Year 6 study period

Timeframe: During the post-marketing study period for Year 1 to Year 6 study period

Secondary outcomes:
Not applicable
Interventions:
  • Biological/vaccine: Rotarix or Rotarix liquid formulation
    • Enrollment:
    3111
    Primary completion date:
    2013-15-06
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    September 2008 to June 2013
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 24 Weeks
    Accepts healthy volunteers
    Yes
    • Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.
    • A male or female infant from the age of 6 weeks at the time of the first vaccination.
    • At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.
    Inclusion and exclusion criteria
    Inclusion criteria:

      Infants who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the PMS.

      • A male or female infant from the age of 6 weeks at the time of the first vaccination.
      • Written informed consent obtained from the parent or guardian of the infant.
    Exclusion criteria:

      At the time of PMS entry, the contraindications and precautions of use indicated in the prescribing information should be checked and the infant must not be included in the PMS if there is any contraindication. Any changes in the locally approved Prescribing Information must be implemented immediately.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Seoul, South Korea, 122-896
    Status
    Study Complete
    Contact us

    Study documents

    Scientific result summary
    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
    2013-15-06
    Actual study completion date
    2013-15-06

    Plain language summaries

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

    Additional information about the trial

    Participate in clinical trial
    Additional information
    Full CSR posting.
    Click here
    Access to clinical trial data by researchers
    Visit website