Last updated: 11/07/2018 04:32:58

Safety study of GSK Biologicals’ rotavirus vaccine (Rotarix®) administered to children aged <1 year in the United States

GSK study ID
112229
See study documents
Clinicaltrials.gov ID
NCT00875641
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 study of GSK Biologicals’ Rotarix® (rotavirus vaccine, live, oral) administered to a birth cohort in United States health insurance plans
Trial description: This observational cohort study, conducted through two existing large administrative health databases in the US (outside the Vaccine Safety Datalink) is planned to confirm the safety profile regarding lack of any association of intussusception with Rotarix within 60 days of vaccination in a real life setting (routine use) in the US. This study will also include monitoring of Kawasaki disease, convulsions, hospitalizations due to acute lower respiratory tract infections and all-cause deaths within 60-days of vaccination.
This study involves three cohorts, one exposed and two control cohorts: infants who receive Rotarix (Exposed cohort) and infants who receive IPV vaccination (Unexposed cohort A and B).
This is a combined prospective and retrospective cohort study.
Prospective component of the study identifies and compares study outcomes following Rotarix and IPV vaccination in the Exposed cohort and Unexposed cohort A, respectively.
Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Incidence Rates of intussusceptions (IS) among the HRV cohort and Comparator cohorts

Timeframe: 60 days following each vaccination

Incidence Rates of IS among the HRV cohort and Comparator cohorts

Timeframe: 7 days following each vaccination

Incidence Rates of IS among the HRV cohort and Comparator cohorts

Timeframe: 30 days following each vaccination

Secondary outcomes:

Incidence Rates of Kawasaki disease among the HRV cohort and Comparator cohorts

Timeframe: 60 days following each vaccination

Incidence Rates of convulsions among the HRV cohort and Comparator cohorts

Timeframe: 60 days following each vaccination

Incidence Rates of acute lower respiratory tract infection (LRTI) hospitalisation among the HRV cohort and Comparator cohorts

Timeframe: 60 days following each vaccination

Incidence Rates of acute LTRI hospitalisation among the HRV cohort and Comparator cohorts

Timeframe: 7 days following each vaccination

Incidence Rates of acute LTRI hospitalisation among the HRV cohort and Comparator cohorts

Timeframe: 30 days following each vaccination

Incidence Rates of all-cause mortality among the HRV cohort and Comparator cohorts

Timeframe: 60 days following each vaccination

Interventions:
  • Other: Health Insurance Database
    • Enrollment:
    390659
    Primary completion date:
    2016-04-11
    Observational study model:
    Cohort
    Time perspective:
    Other
    Clinical publications:
    Hoffman V et al. (2016) Validation of current procedural terminology codes for rotavirus vaccination among infants in two commercially insured US populations. Pharmacoepidemiol Drug Saf. 25(12):1465-1469.
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    April 2009 to November 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    Not applicable - 1 years
    Accepts healthy volunteers
    Yes
    • For Exposed cohort:
    • Infants aged less than 1 year at study entry.
    • For Exposed cohort:
    • Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.
    Inclusion and exclusion criteria
    Inclusion criteria:

      For Exposed cohort:

      • Infants aged less than 1 year at study entry.
      • Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
      • Have complete medical coverage and pharmacy benefits.
      • Received at least one dose of Rotarix from 1 August 2008.
      • Infants receiving Rotarix liquid formulation will also be eligible. For Unexposed cohort A:
      • Infants aged less than 1 year at study entry.
      • Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
      • Have complete medical coverage and pharmacy benefits.
      • Received at least one dose of IPV vaccine from 1 August 2008, with or without RotaTeq vaccination.
      • Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination within the same year. For Unexposed cohort B:
      • Infants who are enrolled in one of the two participating health insurance plans databases within 30 days of birth.
      • Had complete medical coverage and pharmacy benefits.
      • Received at least one dose of IPV vaccine.
      • Vaccinated between 1 January 2006 (inclusive) and 31 July 2008 (inclusive).
      • Not received any dose of rotavirus vaccination.
      • Frequency-matched to the Rotarix cohort by gender, age at first vaccination (±1 week) and calendar quarter of vaccination.
    Exclusion criteria:

      For Exposed cohort:

      • Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period. For Unexposed cohort A:
      • Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period. For Unexposed cohort B:
      • Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Waltham, Massachusetts, United States, 02451
    Status
    Study Complete
    Contact us

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2016-04-11
    Actual study completion date
    2016-04-11

    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
    Access to clinical trial data by researchers
    Visit website