Infections, RotavirusNCT00875641

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

An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 1 yearHealthy volunteers can take part
Conditions the study is for: Infections, Rotavirus
What is being tested?: Health Insurance Database
Type of treatment: Vaccines
How many people: 390,659 participants
Where: 1 siteUnited States
Study dates: 20 Apr 2009to 4 Nov 2016
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 1 year
All sexes
Healthy volunteers accepted
Child

Study population: Children affiliated to two participating health insurance plans.

Who may be able to join

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.

Show all 19Show fewer

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

GSK Investigational Site
Waltham, Massachusetts, 02451

Other trials in United States

About this study

Official title: Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans

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
Being tested: Health Insurance Database
Medical subject headings: Rotavirus Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT00875641
Study group	Role	What they receive
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). Receives: Other: Health Insurance Database
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). Receives: Other: Health Insurance Database
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. Receives: Other: Health Insurance Database

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts
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).
Measured: 60 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
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).
Measured: 7 days following each vaccination
Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts
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).
Measured: 30 days following each vaccination

Secondary outcomes (6)

Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts
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).
Measured: 60 days following each vaccination
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts
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).
Measured: 60 days following each vaccination
Incidence Rates of Acute Lower Respiratory Tract Infection (LRTI) Hospitalisation Among the HRV Cohort and Comparator Cohorts
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).
Measured: 60 days following each vaccination
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
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).
Measured: 7 days following each vaccination
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
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).
Measured: 30 days following each vaccination
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts
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).
Measured: 60 days following each vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Apr 20094 Nov 2016

First posted3 Apr 2009 (estimated)
Study start20 Apr 2009
Primary completion4 Nov 2016
Study completion4 Nov 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Infections, RotavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 390,659 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00875641
Sponsor's protocol ID: 112229
Status last verified: Jun 2018
First submitted: 2 Apr 2009
Last updated: 25 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety Study of GSK Biologicals' Rotarix® (Rotavirus Vaccine, Live, Oral) Administered to a Birth Cohort in United States Health Insurance Plans
ClinicalTrials.gov ID: NCT00875641
Acronym / sponsor ID: 112229
Conditions: Infections, Rotavirus
Study type: Observational
Recruitment status: Completed
Enrolment: 390,659 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 20 Apr 2009 (actual)
Primary completion: 4 Nov 2016 (actual)
Study completion: 4 Nov 2016 (actual)
First posted: 3 Apr 2009 (estimated)
Results: Posted 25 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Retrospective component of the study identifies and compares study outcomes following IPV vaccination in the Unexposed cohort B.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 3

Arm	Type	Receives
HRV cohort	–	Other: Health Insurance DatabaseHRV (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).
Concurrent Control cohort	–	Other: Health Insurance DatabaseConcurrent 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).
Recent Historical Control cohort	–	Other: Health Insurance DatabaseRecent 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.

Who may qualify

Ages: Up to 1 year
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Children affiliated to two participating health insurance plans.

Key inclusion criteria (19 listed)

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.

Key exclusion criteria (6 listed)

Subject has received any dose of RotaTeq prior to the first Rotarix vaccine during the study period.
Subject has received any dose of Rotarix prior to the first IPV vaccine during the study period.
Subject has received any dose of rotavirus vaccines prior to the first IPV vaccine.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Health Insurance DatabaseReview of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination.	Other	Concurrent Control cohort, HRV cohort, Recent Historical Control cohort

Primary outcome

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).
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).
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).

6 secondary outcomes

Incidence Rates of Kawasaki Disease Among the HRV Cohort and Comparator Cohorts
Time frame: 60 days following each vaccination
Incidence Rates of Convulsions Among the HRV Cohort and Comparator Cohorts
Time frame: 60 days following each vaccination
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 of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
Time frame: 7 days following each vaccination
Incidence Rates of Acute LTRI Hospitalisation Among the HRV Cohort and Comparator Cohorts
Time frame: 30 days following each vaccination
Incidence Rates of All-cause Mortality Among the HRV Cohort and Comparator Cohorts
Time frame: 60 days following each vaccination

Results and safety

Results posted to the registry on 25 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HRV Cohort	57,931	57,931
Concurrent Control Cohort	173,384	173,384
Recent Historical Control Cohort	159,344	159,344

Primary outcome: Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts

Time frame: 60 days following each vaccination. Number (95% Confidence Interval). Unit: Incidences/Person-Month

Measure	HRV Cohort n = 57931	Concurrent Control Cohort n = 173384	Recent Historical Control Cohort n = 159344
0-59 days, Any Dose	0.021 (0.006 to 0.055)	0.022 (0.012 to 0.037)	0.021 (0.010 to 0.037)
0-59 days, Dose 1	0.028 (0.006 to 0.082)	0.012 (0.003 to 0.032)	0.017 (0.006 to 0.040)
0-59 days, Dose 2	0.013 (0.000 to 0.070)	0.032 (0.015 to 0.061)	0.025 (0.009 to 0.054)

Population analysed: Analysis was performed on study population comprising of birth cohorts affiliated with 2 participating health insurance plans, United Healthcare \& WellPoint, which were eligible for rotavirus vaccination according to routine recommendations. Within this population of infants, HRV, Concurrent Control \& Recent Historical Control cohorts were defined.

Primary outcome: Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts

Time frame: 7 days following each vaccination. Number (95% Confidence Interval). Unit: Incidences/Person-Month

Measure	HRV Cohort n = 57931	Concurrent Control Cohort n = 173384	Recent Historical Control Cohort n = 159344
0-6 days, Any Dose	0.000 (0.000 to 0.161)	0.014 (0.000 to 0.075)	0.000 (0.000 to 0.056)
0-6 days, Dose 1	0.000 (0.000 to 0.278)	0.000 (0.000 to 0.093)	0.000 (0.000 to 0.101)
0-6 days, Dose 2	0.000 (0.000 to 0.383)	0.029 (0.001 to 0.162)	0.000 (0.000 to 0.124)

Primary outcome: Incidence Rates of IS Among the HRV Cohort and Comparator Cohorts

Time frame: 30 days following each vaccination. Number (95% Confidence Interval). Unit: Incidences/Person-Month

Measure	HRV Cohort n = 57931	Concurrent Control Cohort n = 173384	Recent Historical Control Cohort n = 159344
0-29 days, Any Dose	0.010 (0.000 to 0.058)	0.026 (0.011 to 0.050)	0.022 (0.008 to 0.047)
0-29 days, Dose 1	0.000 (0.000 to 0.066)	0.006 (0.000 to 0.033)	0.020 (0.004 to 0.057)
0-29 days, Dose 2	0.025 (0.001 to 0.137)	0.048 (0.019 to 0.099)	0.024 (0.005 to 0.070)

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HRV Cohort	0 of 57,931 (0%)	0 of 57,931 (0%)	9 of 57,931
Concurrent Control Cohort	0 of 173,384 (0%)	0 of 173,384 (0%)	27 of 173,384
Recent Historical Control Cohort	0 of 159,344 (0%)	0 of 159,344 (0%)	33 of 159,344

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Infections, Rotavirus

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Infections, Rotavirus, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence Rates of Intussusceptions (IS) Among the HRV Cohort and Comparator Cohorts (time frame: 60 days following each vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00875641.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.