Last updated: 11/04/2018 10:29:54

Integrated safety summary of GSK Biologicals’ HRV vaccine (Rotarix™)

GSK study ID
ROTA-Meta-Analysis-201212
See study documents
Clinicaltrials.gov ID
Not applicable
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: Integrated safety summary of GSK Biologicals’ HRV vaccine (Rotarix™)
Trial description: The aim of the Integrated summary of safety (ISS) was to pool the safety data of 26 placebo controlled HRV vaccine studies completed before 30 April, 2011 in order to generate integrated data on solicited symptoms, unsolicited symptoms and serious adverse events (SAEs).
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Occurrence of unsolicited symptoms

Timeframe: Within the 31-day (Day 0 – 30) follow-up period after each vaccination

Occurrence of SAE(s)

Timeframe: During the entire study period

Occurrence of solicited general symptoms

Timeframe: Within the 8-day (Days 0 - 7) follow-up period after each vaccination

Occurrence of SAE(s)

Timeframe: Within the 31-Day (Day 0 – 30) follow-up period after each vaccination

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    102074
    Primary completion date:
    2012-01-12
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Integrated safety analysis of Rotavirus vaccine
    Product
    Rotavirus Vaccine
    Collaborators
    Not applicable
    Study date(s)
    June 2011 to December 2012
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 - 20 Weeks
    Accepts healthy volunteers
    yes
    • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
    • A male or female between, and including, 6 and 20 weeks of age at the time of the first vaccination.
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:

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

      • A male or female between, and including, 6 and 20 weeks of age at the time of the first vaccination.
      • Written informed consent obtained from the parent or guardian of the subject.
      • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
    Exclusion criteria:
    • Not Applicable

    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
    2012-01-12
    Actual study completion date
    2012-01-12

    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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