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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00875641
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

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.


Condition or disease Intervention/treatment
Infections, Rotavirus Other: Health Insurance Database

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Study Type : Observational
Actual Enrollment : 390659 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans
Actual Study Start Date : April 20, 2009
Actual Primary Completion Date : November 4, 2016
Actual Study Completion Date : November 4, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Insurance

Group/Cohort Intervention/treatment
HRV cohort
HRV (Human Rotavirus) cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans within 30 days of birth and who received at least one dose of Rotarix vaccination as part of their normal health care (with no previous dose of RotaTeq prior to or concurrent with the first Rotarix vaccination).
Other: Health Insurance Database
Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.

Concurrent Control cohort
Concurrent control cohort consisted of infants aged less than 1 year, enrolled in the participating health insurance plans, who were contemporaneous with the Rotarix vaccinees and who received at least one dose of IPV (Inactivated Poliovirus vaccine) with or without RotaTeq vaccination (with no previous dose of Rotarix prior to or concurrent with the first IPV vaccination).
Other: Health Insurance Database
Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.

Recent Historical Control cohort
Recent historical control cohort consisted of infants aged less than 1 year of age, enrolled in participating health insurance plans, vaccinated with at least one dose of IPV (Inactivated Poliovirus vaccine) between 1 January 2004 (OptumInsight) or 1 January 2006 (HealthCore) and 31 July 2008 and who did not receive any dose of rotavirus vaccination during the study period.
Other: Health Insurance Database
Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   up to 1 Year   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children affiliated to two participating health insurance plans.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00875641


Locations
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United States, Massachusetts
GSK Investigational Site
Waltham, Massachusetts, United States, 02451
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline

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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00875641    
Other Study ID Numbers: 112229
First Posted: April 3, 2009    Key Record Dates
Results First Posted: January 25, 2019
Last Update Posted: January 25, 2019
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs