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

9 września 2016 zaktualizowane przez: 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).

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

752

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

20 lat do 25 lat (Dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Kobieta

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Cervarix Group
subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
Procedura: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)
Procedura: Blood sampling
Blood samples will be collected at Months 36 and 48 for antibody determination
Komparator placebo: Aimmugen Group
subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
Procedura: Liquid-based cytology (LBC) sampling
LBC samples will be collected at Months 36 and 48 for cytology and HPV DNA testing (by PCR)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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.
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Number of Subjects Reporting Cytological Abnormalities and Lesions Associated With HPV-16 and/or HPV-18.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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.
Ramy czasowe: 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).
Ramy czasowe: 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.
Ramy czasowe: 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).

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

GlaxoSmithKline

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2009

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2011

Ukończenie studiów (Rzeczywisty)

1 lutego 2011

Daty rejestracji na studia

Pierwszy przesłany

26 czerwca 2009

Pierwszy przesłany, który spełnia kryteria kontroli jakości

26 czerwca 2009

Pierwszy wysłany (Oszacować)

29 czerwca 2009

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Oszacować)

20 października 2016

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

9 września 2016

Ostatnia weryfikacja

1 września 2016

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 112949

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAk

Opis planu IPD

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

Badanie danych/dokumentów

  1. Protokół badania
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  2. Raport z badania klinicznego
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  3. Specyfikacja zestawu danych
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  4. Indywidualny zestaw danych uczestnika
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  5. Formularz świadomej zgody
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register
  6. Plan analizy statystycznej
    Identyfikator informacji: 112949
    Komentarze do informacji: For additional information about this study please refer to the GSK Clinical Study Register

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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