- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00196937
Human Papilloma Virus (HPV) Vaccine Immunogenicity and Safety Trial in Young and Adult Women With GSK Biologicals' HPV-16/18
6. Dezember 2019 aktualisiert von: GlaxoSmithKline
Phase 3, Open, Age-stratified Study to Assess Immunogenicity and Safety of GSK Biologicals' HPV-16/18 Vaccine Administered Intramuscularly According to 3-dose Schedule (0,1,6 Months) in Healthy Female Subjects Aged 15 - 55 Years and Long Term Follow-up
Infection with human papillomavirus (HPV) has been clearly established as the central cause of cervical cancer.
Indeed, certain oncogenic types of HPV can infect the cervix (part of the uterus or womb).
This infection may go away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix.
This study will evaluate the immunogenicity and safety of GSK Biologicals HPV-16/18 vaccine over 12 months, in women up to 55 years of age at study start.
Approximately 660 study subjects will receive the HPV vaccine administered intramuscularly according to a 0-1-6 month schedule.
The study will be extended to assess long-term safety and immunogenicity of the HPV-16/18 vaccine.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
667
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
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Berlin, Deutschland, 12200
- GSK Investigational Site
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Bayern
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Muenchen, Bayern, Deutschland, 80799
- GSK Investigational Site
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Wuerzburg, Bayern, Deutschland, 97070
- GSK Investigational Site
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Bydgoszcz, Polen, 85-021
- GSK Investigational Site
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Poznan, Polen, 61-709
- GSK Investigational Site
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Poznan, Polen, 60-533
- GSK Investigational Site
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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
15 Jahre bis 55 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Weiblich
Beschreibung
Inclusion criteria for primary study:
- A woman who the investigator believes that she and/or her parents/legally acceptable representative can and will comply with the requirements of the protocol.
- A woman between, and including, 15 and 55 years of age at the time of the first vaccination.
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject should sign and personally date a written informed assent).
- Free of obvious health problems.
- Subject must have a negative urine pregnancy test.
- Subject must be of non-childbearing potential or, if of childbearing potential, she must be abstinent or must be using adequate contraceptive precautions for 30 days prior to vaccination and must agree to continue such precautions for two months after completion of the vaccination series. Subjects who reach menarche during the study and therefore become of childbearing potential must agree to follow the same precautions
Inclusion criteria for extension studies
- A female who enrolled in the primary study and received three doses of vaccine.
- Written informed consent obtained from the subject prior to enrolment (for subjects below the legal age of consent, written informed consent must be obtained from a parent or legally acceptable representative and, in addition, the subject must sign and personally date a written informed assent).
Exclusion criteria for primary study:
- Pregnant or breastfeeding.
- A woman planning to become pregnant, likely to become pregnant (as determined by the investigator) or planning to discontinue contraceptive precautions during the study period, up to two months after the last vaccine dose.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period (up to Month 12).
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose, or planned administration during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days before and 30 days after the first dose of study vaccine. Planned administration/administration of routine vaccines up to 8 days before the first dose of study vaccine is allowed. Enrolment will be deferred until the subject is outside of specified window.
- Previous administration of components of the investigational vaccine
- Previous vaccination against HPV.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- History of allergic disease, suspected allergy or reactions likely to be exacerbated by any component of the study vaccine.
- Hypersensitivity to latex.
- Known acute or chronic, clinically significant neurologic, hepatic or renal functional abnormality, as determined by previous physical examination or laboratory tests.
- History of chronic condition(s) requiring treatment.
- Administration of immunoglobulins and/or any blood product within 3 months preceding the first dose of study vaccine or planned administration during the study period. Enrolment will be deferred until the subject is outside of specified window.
- Acute disease at the time of enrolment.
Exclusion criteria for extension studies
- Use of any investigational or non-registered product (drug or vaccine) 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 (pharmaceutical product or device).
- Chronic administration of immunosuppressants or other immune-modifying drugs occurring less than 3 months prior to blood sampling.
- Administration of immunoglobulins and/or any blood products within the three months preceding blood sampling.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Cervarix (15-25 Years) Group
Women aged 15 to 25 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
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Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
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Experimental: Cervarix (26-45 Years) Group
Women aged 26 to 45 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
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Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
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Experimental: Cervarix (46-55 Years) Group
Women aged 46 to 55 years received 3 doses of Cervarix vaccine administered according to a 0, 1, 6-month schedule.
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Three doses of vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Seroconverted Subjects for Anti-human Papilloma Virus 16 (Anti-HPV-16) and Anti-human Papilloma Virus 18 (Anti-HPV-18) Antibodies, in Women 15 to 25 Years of Age and Women 26 to 45 Years of Age
Zeitfenster: At Month 7
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [i.e.
antibody titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative before vaccination.
Cut-off values were 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Data for the Cervarix (46-55 Years) Group are presented in the Secondary Outcomes as per Protocol.
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At Month 7
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Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Months 18, 24, 36 and 48
Zeitfenster: At Months 18, 24, 36 and 48
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Anti-HPV 16/18 antibody titers were detected in sera samples and presented as Geometric Mean Titers (GMT), expressed in EL.U/mL.
Data for pre-vaccination, Month 2, Month 7 and Month 12 are presented in the Secondary Outcomes as per Protocol.
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At Months 18, 24, 36 and 48
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Anzahl der Probanden mit erbetenen lokalen Symptomen und Grad 3
Zeitfenster: Während des 7-Tage-Zeitraums (vom Tag der Impfung bis zu 6 darauffolgenden Tagen) nach der Impfung nach jeder Dosis und über mehrere Dosen hinweg
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Als erwünschte lokale Symptome wurden Schmerzen, Rötungen und Schwellungen beurteilt.
Beliebig = Auftreten des Symptoms unabhängig vom Intensitätsgrad.
Schmerz 3. Grades = Schmerz, der eine normale Aktivität verhindert.
Rötung/Schwellung Grad 3 = Rötung/Schwellung, die sich über 50 Millimeter (mm) der Injektionsstelle hinaus ausbreitet.
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Während des 7-Tage-Zeitraums (vom Tag der Impfung bis zu 6 darauffolgenden Tagen) nach der Impfung nach jeder Dosis und über mehrere Dosen hinweg
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Anzahl der Probanden mit irgendwelchen unerwünschten Ereignissen (Grad 3) und damit verbundenen unerwünschten Ereignissen (AEs)
Zeitfenster: Während des 30-tägigen Zeitraums (vom Tag der Impfung bis zu den 29 darauffolgenden Tagen) nach der Impfung
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Eine unaufgeforderte UE deckt jedes unerwünschte medizinische Vorkommnis bei einer klinischen Untersuchungsperson ab, das zeitlich mit der Verwendung eines Arzneimittels in Zusammenhang steht, unabhängig davon, ob es sich um ein mit dem Arzneimittel in Zusammenhang stehendes Ereignis handelt oder nicht, und das zusätzlich zu den während der klinischen Studie erbetenen Ereignissen und allen erbetenen Symptomen, die außerhalb auftreten, gemeldet wird die festgelegte Nachbeobachtungszeit für angeforderte Symptome.
„Jeder“ wurde als das Auftreten eines unerwünschten UE definiert, unabhängig von der Intensitätsstufe oder dem Zusammenhang mit der Impfung.
AE 3. Grades = ein UE, das normale, alltägliche Aktivitäten verhinderte.
Verwandt = vom Prüfer im Zusammenhang mit der Impfung beurteilte UE.
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Während des 30-tägigen Zeitraums (vom Tag der Impfung bis zu den 29 darauffolgenden Tagen) nach der Impfung
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18 Antibodies, in Women 46 - 55 Years of Age
Zeitfenster: At Month 7
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (i.e.
antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion results at Month 7 for the Cervarix (15-25 Years) Group and for the Cervarix (26-45 Years) Group are presented in the Primary Outcome Measure 1.
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At Month 7
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Anti-HPV-16/18 Antibody Titers Assessed by ELISA Based on the ATP Cohort for Immunogenicity at Pre-vaccination (PRE) and Months 2, 7 and 12
Zeitfenster: At PRE and Months 2, 7 and 12
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Anti-HPV 16/18 antibody titers were detected in sera samples and presented as GMT, expressed in EL.U/mL.
Data for Months 18, 24, 36 and 48 are presented in the Primary Outcome Measure 2 as per Protocol.
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At PRE and Months 2, 7 and 12
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Number of Subjects Seroconverted for Anti-HPV-16 and Anti-HPV-18 Antibodies at Month 2 and Month 12
Zeitfenster: At Month 2 and Month 12
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti- HPV-18 antibodies (i.e.
antibody titer ≥ cut-off value) in the sera of subjects seronegative before vaccination.
Cut-off values were 8 EL.U/mL for anti-HPV-16 antibodies and 7 EL.U/mL for anti-HPV-18 antibodies.
Seroconversion results at Month 7 are presented in the Primary Outcome Measure 1 for Cervarix (15-25 Years) Group and Cervarix (26-45 Years) Group and in the Secondary Outcome Measure 3 for the Cervarix (46-55 Years) Group.
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At Month 2 and Month 12
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
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Assessed solicited general symptoms were arthralgia, fatigue, fever, gastrointestinal symptoms, headache, myalgia, rash and urticaria.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 symptom = symptom that prevented normal activity.
Grade 3 fever = fever above (>) 39.0 °C.
Related = symptom assessed by the investigator as related to the vaccination.
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During the 7-day period (from the day of vaccination up to 6 subsequent days) following vaccination after each dose and across doses
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Number of Subjects Reporting Serious Adverse Events (SAE)
Zeitfenster: During the entire study period (from Day 0 up to Month 48)
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An SAE is any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study subject, or may have evolved into one of the outcomes listed above.
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During the entire study period (from Day 0 up to Month 48)
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Number of Subjects Reporting New Onset of Chronic Diseases (NOCDs)
Zeitfenster: During the entire study period (from Day 0 up to Month 48)
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NOCDs assessed include chronic diseases such as autoimmune disorders, diabetes, allergies also asthma and pathognomic signs/symptoms of these diseases.
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During the entire study period (from Day 0 up to Month 48)
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Number of Subjects Reporting Medically Significant Conditions
Zeitfenster: During the entire study period (from Day 0 up to Month 48)
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Medically significant conditions are AEs prompting emergency room or physician visits that were not related to common diseases or routine visits for physical examination or vaccination, or SAEs that were not related to common diseases.
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During the entire study period (from Day 0 up to Month 48)
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Anti-HPV-16/18 Antibody Titers Assessed by ELISA in a Subset of Subjects in Cervical Secretions (CVS) Samples
Zeitfenster: At Months 18 and 24
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Anti-HPV 16/18 antibody titers were detected in CVS samples and presented as GMTs, expressed in EL.U/mL based on ELISA.
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At Months 18 and 24
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Number of Subjects Seropositive for Total Immunoglobulin-G (IgG) in Blood (Serum) and in Cervical Samples (Secretion) in a Subset of Subjects
Zeitfenster: At Months 18 and 24
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Seropositivity was defined as total IgG ≥ 0 microgram per milliliter (µg/mL) and was detected in sera and in CVS samples by ELISA.
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At Months 18 and 24
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Number of Subjects Reporting Pregnancies and Outcomes of Reported Pregnancies
Zeitfenster: During the entire study period (from Day 0 up to Month 48)
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Outcomes of pregnancies were: Abnormal infant / Congenital anomaly, Elective termination, Missed abortion, Normal infant, Premature birth, Spontaneous abortion / Miscarriage and Outcome unknown.
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During the entire study period (from Day 0 up to Month 48)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
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
- Schwarz TF, Kocken M, Petaja T, Einstein MH, Spaczynski M, Louwers JA, Pedersen C, Levin M, Zahaf T, Poncelet S, Hardt K, Descamps D, Dubin G. Correlation between levels of human papillomavirus (HPV)-16 and 18 antibodies in serum and cervicovaginal secretions in girls and women vaccinated with the HPV-16/18 AS04-adjuvanted vaccine. Hum Vaccin. 2010 Dec;6(12):1054-61. doi: 10.4161/hv.6.12.13399. Epub 2010 Dec 1.
- Descamps D, Hardt K, Spiessens B, Izurieta P, Verstraeten T, Breuer T, Dubin G. Safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine for cervical cancer prevention: a pooled analysis of 11 clinical trials. Hum Vaccin. 2009 May;5(5):332-40. doi: 10.4161/hv.5.5.7211. Epub 2009 May 20.
- Boxus M, Lockman L, Fochesato M, Lorin C, Thomas F, Giannini SL. Antibody avidity measurements in recipients of Cervarix vaccine following a two-dose schedule or a three-dose schedule. Vaccine. 2014 May 30;32(26):3232-6. doi: 10.1016/j.vaccine.2014.04.005. Epub 2014 Apr 13.
- Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Perona P, Poncelet S, Zahaf T, Hardt K, Descamps D, Dubin G; HPV Study Group for Adult Women. Immunogenicity and tolerability of an HPV-16/18 AS04-adjuvanted prophylactic cervical cancer vaccine in women aged 15-55 years. Vaccine. 2009 Jan 22;27(4):581-7. doi: 10.1016/j.vaccine.2008.10.088. Epub 2008 Nov 18.
- Schwarz TF, Spaczynski M, Schneider A, Wysocki J, Galaj A, Schulze K, Poncelet SM, Catteau G, Thomas F, Descamps D. Persistence of immune response to HPV-16/18 AS04-adjuvanted cervical cancer vaccine in women aged 15-55 years. Hum Vaccin. 2011 Sep;7(9):958-65. doi: 10.4161/hv.7.9.15999. Epub 2011 Sep 1.
- Schwarz T, Spaczynski M, Kaufmann A, Wysocki J, Galaj A, Schulze K, Suryakiran P, Thomas F, Descamps D. Persistence of immune responses to the HPV-16/18 AS04-adjuvanted vaccine in women aged 15-55 years and first-time modelling of antibody responses in mature women: results from an open-label 6-year follow-up study. BJOG. 2015 Jan;122(1):107-18. doi: 10.1111/1471-0528.13070. Epub 2014 Sep 11.
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 (Tatsächlich)
7. Oktober 2004
Primärer Abschluss (Tatsächlich)
15. Dezember 2005
Studienabschluss (Tatsächlich)
15. Dezember 2005
Studienanmeldedaten
Zuerst eingereicht
13. September 2005
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
13. September 2005
Zuerst gepostet (Schätzen)
20. September 2005
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
11. Dezember 2019
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
6. Dezember 2019
Zuletzt verifiziert
1. Dezember 2019
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- 103514
- 105880 (Andere Kennung: GSK)
- 105879 (Andere Kennung: GSK)
- 105881 (Andere Kennung: GSK)
- 105882 (Andere Kennung: GSK)
- 2004-002083-18 (EudraCT-Nummer)
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.
IPD-Sharing-Zeitrahmen
IPD is available via the Clinical Study Data Request site (click on the link provided below)
IPD-Sharing-Zugriffskriterien
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.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- CSR
Studiendaten/Dokumente
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Kommentiertes Fallberichtsformular
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register. The results of this study 103514 are summarised with studies 105880 and 105881 on the GSK Clinical Study Register.
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Klinischer Studienbericht
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einwilligungserklärung
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 103514Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 103514Informationskommentare: 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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