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| ID | Type | Description | Link |
|---|---|---|---|
| 2010_019 | |||
| EP08014.031 | Other Identifier | Merck |
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| Name | Class |
|---|---|
| Kaiser Permanente | OTHER |
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This is a post-licensure safety surveillance program to detect potential safety signals in subjects, from the managed care organizations database, who have used GARDASIL™.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3-Dose Safety Population (Primary) | Females between ages 9 to 26 at receipt of the first dose of GARDASIL who are members of the participating MCOs and have completed the 3-dose regimen of GARDSIL vaccination with 12 months. | ||
| Pregnancy Safety Population | Females who received at least one dose of GARDASIL during pregnancy. | ||
| Autoimmune Safety Population | Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. | ||
| Any Dose Safety Population (Secondary) | Females who have received at least one dose of GARDASIL and have been members in the same MCO for at least 12 months prior to receiving their first dose of GARDASIL. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Rate of Syncope | Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | On day of each vaccination |
| Incidence Rate of Cellulitis | Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | Within 14 days and within 60 days immediately after each vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy | Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. | First dose of Gardasil in pregnancy up to 6 months after birth |
| Number of Miscarriages Among Females Who Received Gardasil During Pregnancy |
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Inclusion Criteria:
3-Dose Safety Population
Pregnancy Safety Population
Autoimmune Safety Population
Any Dose Safety Population
Exclusion Criteria:
3-Dose Safety Population
Pregnancy Safety Population
Autoimmune Safety Population
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Managed Care Organizations (MCO) databases
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21973261 | Result | Chao C, Klein NP, Velicer CM, Sy LS, Slezak JM, Takhar H, Ackerson B, Cheetham TC, Hansen J, Deosaransingh K, Emery M, Liaw KL, Jacobsen SJ. Surveillance of autoimmune conditions following routine use of quadrivalent human papillomavirus vaccine. J Intern Med. 2012 Feb;271(2):193-203. doi: 10.1111/j.1365-2796.2011.02467.x. Epub 2011 Nov 15. | |
| 23027469 |
| Label | URL |
|---|---|
| EUPAS Register (EUPAS17730) | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Any Dose Safety Population | Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Any Dose Safety Population | Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 Rate of Syncope | Syncope was defined as the presence of a syncope diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | Posted | Number | Rate per 1000 person years | On day of each vaccination |
|
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Per protocol, non-serious adverse events and serious adverse events (SAEs)
were not required to be captured as part of the study database, therefore, none were collected, and the number at risk is zero.
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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 | Any Dose Safety Population | Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008. |
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Details of syncope and cellulitis findings and null findings for hundreds of other general safety analyses will be described in future publications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. |
| First dose of Gardasil in pregnancy up to pregnancy resolution |
| Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil | Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest. | within 6 months immediately after each vaccination |
| Klein NP, Hansen J, Chao C, Velicer C, Emery M, Slezak J, Lewis N, Deosaransingh K, Sy L, Ackerson B, Cheetham TC, Liaw KL, Takhar H, Jacobsen SJ. Safety of quadrivalent human papillomavirus vaccine administered routinely to females. Arch Pediatr Adolesc Med. 2012 Dec;166(12):1140-8. doi: 10.1001/archpediatrics.2012.1451. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
|
|
|
| Secondary | Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy | Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. | Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records. | Posted | Number | Number of congenital anomalies | First dose of Gardasil in pregnancy up to 6 months after birth |
|
|
|
| Secondary | Number of Miscarriages Among Females Who Received Gardasil During Pregnancy | Pregnancy exposure was defined as receipt of Gardasil at any time from 1 month prior to conception through end of pregnancy. | Number of females potentially exposed to Gardasil during potential pregnancy as identified from unconfirmed diagnosis codes in electronic medical records. | Posted | Number | Number of miscarriages | First dose of Gardasil in pregnancy up to pregnancy resolution |
|
|
|
| Secondary | Number of Cases of New Onset Autoimmune Conditions in Females Receiving at Least One Dose of Gardasil | Autoimmune cases were defined as newly diagnosed cases within 6 months after any dose of Gardasil, as confirmed by medical record review by panels of physicians specializing in the 16 autoimmune conditions of interest. | Number of females with at least 12 months' membership at a MCO prior to Gardasil. | Posted | Number | Number of autoimmune cases | within 6 months immediately after each vaccination |
|
|
|
| Primary | Incidence Rate of Cellulitis | Cellulitis was defined as the presence of a cellulitis or abscess diagnosis code in the emergency room or hospital setting in the vaccination risk period or in the post-vaccination self-comparison period. These codes could have represented a new event, a pre-existing event, a prior history of the event, a "rule out" diagnosis, miscoding, or a misdiagnosis. Consistent with the study's design, diagnosis codes for general safety analyses were not confirmed in this study. | Posted | Number | Rate per 1000 person years | Within 14 days and within 60 days immediately after each vaccination |
|
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Title | Measurements |
|---|---|
|
| No. associated with Gardasil by safety committee |
|
| Title | Measurements |
|---|---|
|
| No. associated with Gardasil by safety committee |
|
| Title | Measurements |
|---|---|
|
| No. associated with Gardasil by safety committee |
|
| unconditional logistic regression |
| Relative Risk |
| 1.05 |
| 2-Sided |
| 95 |
| 0.82 |
| 1.35 |
Relative risk was approximated by odds ratio, obtained from conditional logistic regression. |
| Superiority or Other |
| Days 1-14 after vaccination. | unconditional logistic regression | Relative Risk | 1.02 | 2-Sided | 95 | 0.53 | 1.98 | Relative risk was approximated by odds ratio, obtained from conditional logistic regression. | Superiority or Other |
| Days 1-60 after vaccination. | unconditional logistic regression | Relative Risk | 0.78 | 2-Sided | 95 | 0.5 | 1.21 | Relative risk was approximated by odds ratio, obtained from conditional logistic regression. | Superiority or Other |