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Observational Surveillance Study to Detect Potential Safety Signals in Patients Who Have Had at Least One Dose of GARDASIL™ (V501-031)

9. juni 2017 opdateret af: 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™.

Studieoversigt

Status

Afsluttet

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

189629

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

9 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Merck Sharp & Dohme LLC

Samarbejdspartnere

Kaiser Permanente

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. februar 2007

Primær færdiggørelse (Faktiske)

13. december 2010

Studieafslutning (Faktiske)

13. december 2010

Datoer for studieregistrering

Først indsendt

26. februar 2010

Først indsendt, der opfyldte QC-kriterier

1. marts 2010

Først opslået (Skøn)

2. marts 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. juni 2017

Sidst verificeret

1. juni 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • V501-031
  • 2010_019
  • EP08014.031 (Anden identifikator: Merck)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

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Placeringer

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