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

9. September 2016 aktualisiert von: 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).

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

752

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

20 Jahre bis 25 Jahre (Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Cervarix Group
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
Verfahren: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
Verfahren: Blood sampling
Blood samples will be collected at Months 36 and 48 for antibody determination
Placebo-Komparator: Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Verfahren: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
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.
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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.
Zeitfenster: 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).
Zeitfenster: 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.
Zeitfenster: 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).

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2009

Primärer Abschluss (Tatsächlich)

1. Februar 2011

Studienabschluss (Tatsächlich)

1. Februar 2011

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

26. Juni 2009

Zuerst gepostet (Schätzen)

29. Juni 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

20. Oktober 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. September 2016

Zuletzt verifiziert

1. September 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 112949

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Ja

Beschreibung des IPD-Plans

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

Studiendaten/Dokumente

  1. Studienprotokoll
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinischer Studienbericht
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Datensatzspezifikation
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Einzelner Teilnehmerdatensatz
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einwilligungserklärung
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistischer Analyseplan
    Informationskennung: 112949
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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