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Safety Evaluation of the GSK-580299 Vaccine in Women From the Control Group in the Primary NCT00294047 Study

6. juni 2019 oppdatert av: GlaxoSmithKline

Safety Study of GSK Biologicals' Human Papillomavirus Vaccine (GSK-580299) in Healthy Female Control Subjects From the Primary NCT00294047 Study

This extension study is designed to assess the safety of GSK Biological's human papillomavirus (HPV) vaccine GSK580299 in female subjects who took part in the primary study NCT00294047 and received the control vaccine in countries for which the licensed GSK HPV vaccine is not indicated for the subject's age group (26 years and older). This study is thus conducted to enable all women who received the control placebo in the primary NCT00294047 study to receive the GSK580299 vaccine.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

This Protocol Posting has been updated following Protocol Amendment 1, December 2010, leading to the update of 1 of the primary outcome measures and following Protocol Amendment 2, January 2011, leading to the removal of one of the exclusion criteria.

Studietype

Intervensjonell

Registrering (Faktiske)

137

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Canada
      • Quebec, Canada, G1S 2L6
        • GSK Investigational Site
    • Alberta
      • Edmonton, Alberta, Canada, T5A 4L8
        • GSK Investigational Site
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • GSK Investigational Site
      • Truro, Nova Scotia, Canada, B2N 1L2
        • GSK Investigational Site
    • Ontario
      • Waterloo, Ontario, Canada, N2L 6H6
        • GSK Investigational Site
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H 1Z1
        • GSK Investigational Site
  • Forente stater
    • Colorado
      • Aurora, Colorado, Forente stater, 80045
        • GSK Investigational Site
      • Golden, Colorado, Forente stater, 80401
        • GSK Investigational Site
    • Florida
      • Coral Gables, Florida, Forente stater, 33134
        • GSK Investigational Site
      • Miami, Florida, Forente stater, 33136
        • GSK Investigational Site
    • Georgia
      • Augusta, Georgia, Forente stater, 30912
        • GSK Investigational Site
    • Iowa
      • Iowa City, Iowa, Forente stater, 52242
        • GSK Investigational Site
    • Kansas
      • Wichita, Kansas, Forente stater, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Forente stater, 40004
        • GSK Investigational Site
      • Louisville, Kentucky, Forente stater, 40202
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forente stater, 68131
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, Forente stater, 03756
        • GSK Investigational Site
    • North Carolina
      • New Bern, North Carolina, Forente stater, 28562
        • GSK Investigational Site
    • Ohio
      • Cleveland, Ohio, Forente stater, 44122
        • GSK Investigational Site
    • Pennsylvania
      • Carnegie, Pennsylvania, Forente stater, 15106
        • GSK Investigational Site
      • Erie, Pennsylvania, Forente stater, 16508
        • GSK Investigational Site
      • Erie, Pennsylvania, Forente stater, 16507
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forente stater, 15236
        • GSK Investigational Site
    • Texas
      • Houston, Texas, Forente stater, 77030
        • GSK Investigational Site
    • Utah
      • Salt Lake City, Utah, Forente stater, 84109
        • GSK Investigational Site
      • Salt Lake City, Utah, Forente stater, 84121
        • GSK Investigational Site
    • Washington
      • Wenatchee, Washington, Forente stater, 98801
        • GSK Investigational Site

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

26 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Hunn

Beskrivelse

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A subject previously enrolled in study NCT00294047, who received the control vaccine, and who cannot receive the GSK580299 vaccine because the subject is above the age for which the vaccine is licensed.
  • Written informed consent obtained from the subject
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.

  • Female subjects of childbearing potential may be enrolled in the study, if the subject:

    • has practiced adequate contraception for 30 days prior to vaccination, and
    • has a negative pregnancy test on the day of vaccination, and
    • has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Pregnant or breastfeeding.
  • A women planning to become pregnant, likely to become pregnant or planning to discontinue contraceptive precautions during the vaccination phase of the study, i.e. up to two months after the last vaccine dose.
  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Previous vaccination against HPV or planned administration of another HPV vaccine during the study other than that foreseen in the protocol.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this will mean prednisone greater than or equal to 20 mg/day, or equivalent. Inhaled and topical steroids are allowed
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days (i.e., Day 0-29) of each dose of vaccine, with the exception of administration of routine meningococcal, hepatitis B, hepatitis A, inactivated influenza, diphtheria/tetanus and/or diphtheria/tetanus-containing vaccine up to 8 days before each dose of study vaccine. Enrolment will be deferred until the subject is outside of specified window.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.

NOTE: Subjects enrolled in this study may also be eligible for a four-year gynaecological follow-up of the HPV-015 study, in which no investigational product will be administered. Subjects will be invited to the gynaecological follow-up study if either of the following applies:

  • if they test positive for oncogenic HPV infection, but display normal cervical cytology at their concluding HPV-015 study end visit;

  • if they are pregnant so that no cervical sample can be taken at their concluding HPV-015 study end visit;

    • Previous administration of any components of the vaccine.
    • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
    • Cancer or autoimmune disease under treatment.
    • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
    • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine
    • History of any neurological disorders or seizures.
    • Acute disease and/or fever at the time of enrolment.
    • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Cervarix Group
Healthy female subjects who received control vaccine in the primary study HPV-015 (NCT00294047), were administered three doses of Cervarix vaccine intramuscularly, according to a 0,1,6-month schedule.
Biologisk: GSK580299 (Cervarix)
3-dose skjema intramuskulær vaksinasjon

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of Subjects Reporting Any, Grade 3 and Related Serious Adverse Events (SAEs)
Tidsramme: During the entire study period (from Day 0 up to Month 12)
Assessed SAEs included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or were congenital anomalies/birth defects in the offspring of a study subject. Any SAE = occurrence of the SAE regardless of intensity grade. Grade 3 SAE = an SAE which prevented normal, everyday activities. Related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Tidsramme: During the entire study period (from Day 0 up to Month 12)
Medically significant conditions were defined as: AEs prompting emergency room or physician visits that were not (1) related to common diseases, or (2) not related to routine visits for physical examination or vaccination, or as SAEs that were not related to common diseases. Common diseases included: upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections, cervicovaginal yeast infections, menstrual cycle abnormalities and injury. Any MSC = occurrence of the MSC regardless of intensity grade. Grade 3 MSC = a MSC which prevented normal, everyday activities. Related MSC = MSC assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Any, Grade 3 and Related Potentially Immune-Mediated Diseases (pIMDs)
Tidsramme: During the entire study period (from Day 0 up to Month 12)
pIMD(s) are a subset of medically significant conditions (MSCs) that included autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have had an autoimmune aetiology. Any pIMD = occurrence of the pIMD regardless of intensity grade. Grade 3 pIMD = a pIMD which prevented normal, everyday activities. Related pIMD = pIMD assessed by the investigator as related to the study vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects Reporting Pregnancies and Outcomes of the Reported Pregnancies
Tidsramme: During the entire study period (from Day 0 up to Month 12)
Pregnancy is the term used to describe the period in which a fetus develops inside a woman's womb or uterus. In this study, the number of subjects with pregnancies was calculated. The subjects with confirmed pregnancies were followed up to determine the outcomes of the reported pregnancies.
During the entire study period (from Day 0 up to Month 12)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

GlaxoSmithKline

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)

1. april 2011

Primær fullføring (Faktiske)

23. november 2017

Studiet fullført (Faktiske)

23. november 2017

Datoer for studieregistrering

Først innsendt

26. august 2010

Først innsendt som oppfylte QC-kriteriene

26. august 2010

Først lagt ut (Anslag)

27. august 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

19. juni 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juni 2019

Sist bekreftet

1. juni 2019

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • 113621

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

IPD is available via the Clinical Study Data Request site (click on the link provided below)

IPD-delingstidsramme

IPD is available via the Clinical Study Data Request site (click on the link provided below)

Tilgangskriterier for IPD-deling

Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • SEVJE
  • ICF
  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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