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

NCT ID: NCT00875641

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 390659 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-04-20
• Study Completion Date: 2016-11-04

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.

Conditions

Infections, Rotavirus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

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).

Health Insurance Database

Intervention Type: OTHER

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).

Health Insurance Database

Intervention Type: OTHER

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.

Health Insurance Database

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility 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.

• Maximum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Waltham, Massachusetts, United States

Countries

United States

Other Identifiers

112229

Identifier Type: -

Identifier Source: org_study_id