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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00875641
First Posted: April 3, 2009
Last Update Posted: October 31, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
  Purpose

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 Intervention
Infections, Rotavirus Procedure: Health Insurance Database

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of medically-attended definite IS as identified from claims database and confirmed through medical record review. [ Time Frame: 60 days following vaccination. ]

Secondary Outcome Measures:
  • Occurrence of medically-attended Kawasaki disease as identified from claims database and confirmed through medical record review [ Time Frame: 60 days following vaccination ]
  • Occurrence of medically-attended convulsions identified from claims database and confirmed through medical record review [ Time Frame: 60 days following vaccination ]
  • Occurrence of medically-attended acute LRTI hospitalizations identified from claims database [ Time Frame: 60 days following vaccination ]
  • Occurrence of all-cause deaths identified from claims database [ Time Frame: 60 days following vaccination ]

Enrollment: 127120
Study Start Date: April 2009
Study Completion Date: November 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Exposed cohort
Infants aged less than 1 year who are eligible for rotavirus vaccination and receive at least one dose of Rotarix according to routine recommendations.
Procedure: 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.
Unexposed cohort A
Infants aged less than 1 year who receive at least one dose of IPV (but NO dose of Rotarix) after 1 August 2008. The infants may or may not receive RotaTeq. All vaccines are provided according to routine recommendations.
Procedure: 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.
Unexposed cohort B
Infants aged less than 1 year who receive at least one dose of IPV between 1 January 2006 and 31 July 2008. All vaccines are provided according to routine recommendations.
Procedure: 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.

  Eligibility

Information from the National Library of Medicine

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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.

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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00875641     History of Changes
Other Study ID Numbers: 112229
First Submitted: April 2, 2009
First Posted: April 3, 2009
Last Update Posted: October 31, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs