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Extension Study of the Efficacy of the GSK 580299 Vaccine in Japanese Women Vaccinated in the Primary NCT00316693 Study

perjantai 9. syyskuuta 2016 päivittänyt: GlaxoSmithKline

Long-term Extension Study of the Efficacy of the 580299 Vaccine in the Prevention of HPV-16 and/or HPV-18 Associated Cervical Intraepithelial Neoplasia (CIN) in Japanese Women Vaccinated in the Primary Vaccination Study NCT00316693

This extension study is conducted to assess the efficacy of the GSK 580299 vaccine against cervical intraepithelial neoplasia (CIN) lesions, cervical cancer and cytological abnormalities associated with human papillomavirus (HPV)-16 and/or HPV-18 or other oncogenic HPV types for an additional two years. All subjects who participated in the primary vaccination study NCT00316693 and who confirmed their interest in participating in a long term follow up study will therefore be invited to be followed for up to 48 months after administration of the first dose of vaccine. In addition, safety and persistence of the humoral immune response will be evaluated in this study.

This protocol posting deals with objectives & outcome measures of the extension phase at Months 36 and 48. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00316693).

Tutkimuksen yleiskatsaus

Tila

Valmis

Ehdot

Interventio / Hoito

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

752

Vaihe

  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

  • Japani
      • Aomori, Japani, 036-8003
        • GSK Investigational Site
      • Fukui, Japani, 910-0858
        • GSK Investigational Site
      • Hiroshima, Japani, 733-0813
        • GSK Investigational Site
      • Hiroshima, Japani, 734-0036
        • GSK Investigational Site
      • Kagoshima, Japani, 890-0055
        • GSK Investigational Site
      • Kagoshima, Japani, 892-0824
        • GSK Investigational Site
      • Miyazaki, Japani, 889-1692
        • GSK Investigational Site
      • Osaka, Japani, 530-0013
        • GSK Investigational Site
      • Tokyo, Japani, 102-0083
        • GSK Investigational Site
      • Tokyo, Japani, 160-0017
        • GSK Investigational Site
      • Tokyo, Japani, 173-0005
        • GSK Investigational Site
      • Tokyo, Japani, 183-0056
        • GSK Investigational Site
      • Tokyo, Japani, 189-0014
        • GSK Investigational Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

20 vuotta - 25 vuotta (Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Sukupuolet, jotka voivat opiskella

Nainen

Kuvaus

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol;
  • Written informed consent obtained from the subject prior to enrolment in the extension study;
  • A subject previously vaccinated in the NCT00316693 study.
  • Subjects who showed, at the last NCT00316693 study visit (at Month 24) willingness to participate in this extension study.

Exclusion Criteria:

  • Use of any HPV vaccine other than the one administered in the NCT00316693 study;
  • Use of any investigational or non-registered product other than the study vaccine since last NCT00316693 study visit, or planned use during the study period;
  • 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;
  • Subjects who were diagnosed high grade or missing cytology at Month 0 in the NCT00316693 study;
  • Pregnant females and females who were pregnant less than 3 months ago.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Ei mitään (avoin tarra)

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Cervarix Group
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
Menettely: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
Menettely: Blood sampling
Blood samples will be collected at Months 36 and 48 for antibody determination
Placebo Comparator: Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Menettely: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Subjects Reporting Histopathologically Confirmed Cervical Intraepithelial Neoplasia (CIN)1+ Cases Associated With HPV16 and/or HPV18 Detected Within the Lesional Component of the Cervical Tissue Specimen.
Aikaikkuna: From Month 0 up to Month 12

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN grade 1 (CIN1), CIN grade 2 (CIN2), CIN grade 3 (CIN3), adenocarcinoma in situ (AIS) or invasive cervical cancer (ICC).

Detection of vaccine oncogenic Human papillomavirus (HPV) types 16 or 18 was made by polymerase chain reaction (PCR).

For single type: Subjects Deoxyribonucleic acid (DNA) negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
From Month 0 up to Month 12

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
Aikaikkuna: From Month 0 up to Month 12

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as atypical squamous cell of undetermined significance (ASC-US), low-grade squamous intraepithelial lesions (LSIL), high-grade squamous intraepithelial lesions (HSIL), atypical squamous cell-cannot exclude HSIL (ASC-H) and atypical glandular cells (AGC).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
From Month 0 up to Month 12
Number of Subjects Reporting Cytologically Confirmed Abnormalities and Lesions Concurrently Associated With Any Oncogenic HPV Types.
Aikaikkuna: From Month 0 up to Month 12

Cytologically confirmed abnormalities and lesions (ASC-US+) are defined as ASC-US, LSIL, HSIL, ASC-H and AGC.

HR= High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
From Month 0 up to Month 12
Number of Subjects Reporting CIN1+ Associated With Any Oncogenic HPV Types Detected Within the Lesional Component of the Cervical Tissue Specimen.
Aikaikkuna: From Month 0 up to Month 12

Low-grade cervical lesions and higher lesions are defined as CIN1+, i.e. CIN1, CIN2, CIN3, AIS or ICC.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
From Month 0 up to Month 12
Number of Subjects Reporting Incident Cervical Infection Associated With HPV-16 and/or 18.
Aikaikkuna: From Month 0 up to Month 12

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
From Month 0 up to Month 12
Number of Subjects Reporting Incident Cervical Infection With Any Oncogenic HPV Types.
Aikaikkuna: From Month 0 up to Month 12
HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
From Month 0 up to Month 12
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With HPV-16 and/or 18.
Aikaikkuna: From Month 0 up to Month 12

Persistent infection (12-month definition): detection of at least 2 positive HPV DNA PCR assays for the same viral genotype with no negative DNA sample between the 2 positive DNA samples, over an approximate interval of 12 months (>300 days).

For single type: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for the corresponding HPV type.

For combined types: Subjects DNA negative at Month 0 and Month 6 and seronegative at Month 0 for at least one HPV type.
From Month 0 up to Month 12
Number of Subjects Reporting Persistent Long-term Cervical Infection (12-month Definition) With Any Oncogenic HPV-types.
Aikaikkuna: From Month 0 up to Month 12

Persistent infection: subjects with at least 2 positive samples (difference > than 300 days) and no negative samples in between.

HR=High-risk HPV-types: HPV-16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68.
From Month 0 up to Month 12
Number of Subjects With HPV-16 and HPV-18 Antibodies Titers Equal to or Above the Assay Cut-off Values.
Aikaikkuna: At Month 0 and at Month 12
Assay cut-off values assessed were 8 Enzyme-linked Immunosorbent Assay (ELISA) units per millilitre (EL.U/mL) for HPV-16 antibodies and 7 ELISA units per millilitre (EL.U/mL) for HPV-18 antibodies in the Cervarix Group.
At Month 0 and at Month 12
HPV-16 and HPV-18 Antibody Titers
Aikaikkuna: At Month 0 and at Month 12
Titers were expressed as Geometric Mean Titers (GMTs). Geometric mean titres were assessed by ELISA in the Cervarix Group.
At Month 0 and at Month 12
Number of Subjects Reporting Serious Adverse Events (SAEs).
Aikaikkuna: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Number of Subjects With New Onset of Chronic Diseases (NOCDs) Regardless of Causal Relationship to Vaccination and Intensity.
Aikaikkuna: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
NOCDs included autoimmune diseases, diabetes mellitus.
During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Number of Subjects With New Onset of Autoimmune Diseases (NOADs) Regardless of Causal Relationship to Vaccination and Intensity.
Aikaikkuna: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Number of Subjects With Medically Significant Conditions (MSCs).
Aikaikkuna: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
MSCs were defined as adverse events (AEs) prompting emergency room or physician visits that were not (1) related to common diseases or (2) routine visits for physical examination or vaccination, or SAEs that were not related to common disease.
During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12
Number of Subjects With Pregnancies and Pregnancy Outcomes.
Aikaikkuna: During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).
Pregnancy outcomes are live infant, elective termination, ectopic pregnancy, stillbirth, spontaneous abortion, lost to follow-up and pregnancy ongoing. For each category it was specified if the infant presents congenital anomaly (CA) or no apparent congenital anomaly (No ACA).
During the follow-up period from last study visit at Month 24 in the primary vaccination study NCT00316693 until the end of this follow-up study at Month 12 (Month 48 Ext- NCT00316693).

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

GlaxoSmithKline

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Yleiset julkaisut

Hyödyllisiä linkkejä

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Maanantai 1. kesäkuuta 2009

Ensisijainen valmistuminen (Todellinen)

Tiistai 1. helmikuuta 2011

Opintojen valmistuminen (Todellinen)

Tiistai 1. helmikuuta 2011

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 26. kesäkuuta 2009

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 26. kesäkuuta 2009

Ensimmäinen Lähetetty (Arvio)

Maanantai 29. kesäkuuta 2009

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Arvio)

Torstai 20. lokakuuta 2016

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Perjantai 9. syyskuuta 2016

Viimeksi vahvistettu

Torstai 1. syyskuuta 2016

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Avainsanat

Muita asiaankuuluvia MeSH-ehtoja

Muut tutkimustunnusnumerot

  • 112949

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

Joo

IPD-suunnitelman kuvaus

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Tutkimustiedot/asiakirjat

  1. Tutkimuspöytäkirja
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  2. Kliinisen tutkimuksen raportti
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  3. Tietojoukon määritys
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  4. Yksittäisen osallistujan tietojoukko
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  5. Ilmoitettu suostumuslomake
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  6. Tilastollinen analyysisuunnitelma
    Tiedon tunniste: 112949
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

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