Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)
9. juni 2017 oppdatert av: 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™.
Studieoversikt
Status
Fullført
Studietype
Observasjonsmessig
Registrering (Faktiske)
189629
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
9 år og eldre (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Hunn
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
Managed Care Organizations (MCO) databases
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence Rate of Syncope
Tidsramme: 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
|
|
Incidence Rate of Cellulitis
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Congenital Anomalies Among Females Who Received Gardasil During Pregnancy
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. februar 2007
Primær fullføring (Faktiske)
13. desember 2010
Studiet fullført (Faktiske)
13. desember 2010
Datoer for studieregistrering
Først innsendt
26. februar 2010
Først innsendt som oppfylte QC-kriteriene
1. mars 2010
Først lagt ut (Anslag)
2. mars 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. juli 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. juni 2017
Sist bekreftet
1. juni 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- V501-031
- 2010_019
- EP08014.031 (Annen identifikator: Merck)
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