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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by GlaxoSmithKline
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00875641
First received: April 2, 2009
Last updated: March 6, 2014
Last verified: March 2014
  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
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. ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • Occurrence of medically-attended convulsions identified from claims database and confirmed through medical record review [ Time Frame: 60 days following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of medically-attended acute LRTI hospitalizations identified from claims database [ Time Frame: 60 days following vaccination ] [ Designated as safety issue: No ]
  • Occurrence of all-cause deaths identified from claims database [ Time Frame: 60 days following vaccination ] [ Designated as safety issue: No ]

Estimated Enrollment: 389900
Study Start Date: April 2009
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (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

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00875641

Contacts
Contact: US GSK Clinical Trials Call Center 877-379-3718 GSKClinicalSupportHD@gsk.com

Locations
United States, Massachusetts
GSK Investigational Site Recruiting
Waltham, Massachusetts, United States, 02451
Contact: US GSK Clinical Trials Call Center    877-379-3718    GSKClinicalSupportHD@gsk.com   
Contact: EU GSK Clinical Trials Call Center    +44 (0) 20 8990 4466    GSKClinicalSupportHD@gsk.com   
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00875641     History of Changes
Other Study ID Numbers: 112229
Study First Received: April 2, 2009
Last Updated: March 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Rotavirus Infections
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on August 25, 2014