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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Insurance Database | Other | Review of two health insurance databases in the US to determine the safety outcomes among infants who have received Rotarix or IPV vaccination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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). | 30 days following each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
For Exposed cohort:
For Unexposed cohort A:
For Unexposed cohort B:
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.
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Children affiliated to two participating health insurance plans.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Waltham | Massachusetts | 02451 | United States |
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Subjects were identified through the automated corresponding health insurance plan databases, OptumInsight Life Sciences Research Database (from United Healthcare) and the HealthCore Integrated Research Database (HIRDSM) (part of Anthem, formerly known as WellPoint).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 60 days following each vaccination |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| 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). | 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). | 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). | 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). | 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). | 60 days following each vaccination |
| BG001 |
| 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). |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Months |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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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).
| OG001 | 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). |
| OG002 | 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. |
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| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 7 days following each vaccination |
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| Primary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 30 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 60 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 60 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 60 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 7 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 30 days following each vaccination |
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| Secondary | 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). | 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. | Posted | Number | 95% Confidence Interval | Incidences/Person-Month | 60 days following each vaccination |
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| 9 |
| 57,931 |
| 0 |
| 57,931 |
| 0 |
| 57,931 |
| EG001 | 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). | 27 | 173,384 | 0 | 173,384 | 0 | 173,384 |
| EG002 | 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. | 33 | 159,344 | 0 | 159,344 | 0 | 159,344 |
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
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| 0-6 days, Dose 2 |
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| 0-29 days, Dose 2 |
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| 0-59 days, Dose 2 |
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| 0-59 days, Dose 2 |
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| 0-59 days, Dose 2 |
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| 0-6 days, Dose 2 |
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| 0-29 days, Dose 2 |
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| 0-59 days, Dose 2 |
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