Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Ye… (NCT00875641) | Clinical Trial Compass
CompletedNot Applicable
Safety Study of GSK Biologicals' Rotavirus Vaccine (Rotarix®) Administered to Children Aged <1 Year in the United States
United States390,659 participantsStarted 2009-04-20
Plain-language 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 vacc…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
Timeframe: 60 days following each vaccination
2
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
Timeframe: 7 days following each vaccination
3
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts