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Completed

NCT Number: NCT00875641

Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States

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.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 1 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Waltham, Massachusetts, 02451, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Health Insurance Database

Other

Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.

Primary outcomes

  1. Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts

    Time frame: 60 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  2. Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts

    Time frame: 7 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  3. Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts

    Time frame: 30 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Secondary outcomes

  1. Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts

    Time frame: 60 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  2. Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts

    Time frame: 60 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  3. Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts

    Time frame: 60 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  4. Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts

    Time frame: 7 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  5. Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts

    Time frame: 30 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

  6. Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts

    Time frame: 60 days following each vaccination

    Incidence rates were calculated following the first 2 doses of study vaccine as the number of events divided by the sum of the person-time in that risk period. Person-time was defined as the number of days at risk for the study outcomes. Person-time was calculated in months by dividing the number of person-days by (365.25/12).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2009
Registry last updated
Jan 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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