Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
9 juni 2017 bijgewerkt door: Merck Sharp & Dohme LLC
A Post-licensure Surveillance Program for the Safety of GARDASIL™ in a Managed Care Organization Setting
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™.
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Observationeel
Inschrijving (Werkelijk)
189629
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
9 jaar en ouder (Kind, Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Vrouw
Bemonsteringsmethode
Kanssteekproef
Studie Bevolking
Managed Care Organizations (MCO) databases
Beschrijving
Inclusion Criteria:
3-Dose Safety Population
- Female 9-26 years at the time of first dose of GARDASIL™
- Completed the 3-dose regimen of GARDASIL™ per protocol
Pregnancy Safety Population
- Received at least one dose of GARDASIL™ up to 30 days prior to the date of conception or any time between conception and the day of pregnancy resolution
Autoimmune Safety Population
- Female who has received at least one dose of GARDASIL™
- Has been a member of same Managed Care Organization (MCO) for at least 12 months prior to the receipt of GARDASIL™
Any Dose Safety Population
- Female who has received at least one dose of GARDASIL™
Exclusion Criteria:
3-Dose Safety Population
- Male
- Receives incomplete regimen of GARDASIL™
- Completes the three dose regimen of GARDASIL™ in more than 12 months
- Less than 28 day interval between doses 1 and 2 or less than a 12 week interval between doses 2 and 3
- Younger than 9 or older than 26 years of age at receipt of first dose
Pregnancy Safety Population
- Males
- No record of pregnancy at the Managed Care Organization (MCO)
Autoimmune Safety Population
- Member of the same MCO for less than 12 months prior to receiving the first dose
- Male
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
|---|
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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.
|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence Rate of Syncope
Tijdsspanne: On day of each vaccination
|
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
|
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Incidence Rate of Cellulitis
Tijdsspanne: Within 14 days and within 60 days immediately after each vaccination
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
Tijdsspanne: First dose of Gardasil in pregnancy up to 6 months after birth
|
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
Tijdsspanne: First dose of Gardasil in pregnancy up to pregnancy resolution
|
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
Tijdsspanne: within 6 months immediately after each vaccination
|
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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Medewerkers
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
- 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.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
6 februari 2007
Primaire voltooiing (Werkelijk)
13 december 2010
Studie voltooiing (Werkelijk)
13 december 2010
Studieregistratiedata
Eerst ingediend
26 februari 2010
Eerst ingediend dat voldeed aan de QC-criteria
1 maart 2010
Eerst geplaatst (Schatting)
2 maart 2010
Updates van studierecords
Laatste update geplaatst (Werkelijk)
11 juli 2017
Laatste update ingediend die voldeed aan QC-criteria
9 juni 2017
Laatst geverifieerd
1 juni 2017
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- V501-031
- 2010_019
- EP08014.031 (Andere identificatie: Merck)
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