- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00309166
Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.
5. Februar 2018 aktualisiert von: GlaxoSmithKline
An Observer-blind, Randomized, Controlled Study to Assess the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine Administered Intramuscularly According to a 0, 1, 6 Month Schedule in Healthy Male Subjects Aged 10-18 Years
The main aim of this vaccine is to prevent cervical cancer in women.
However, it could also be relevant to vaccinate selected groups of males.
Therefore, this study is designed to evaluate the safety and immunogenicity of the HPV vaccine in pre-teen and adolescent male subjects aged 10-18 years.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
270
Phase
- Phase 2
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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Kotka, Finnland, 48100
- GSK Investigational Site
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Kouvola, Finnland, 45100
- GSK Investigational Site
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Mikkeli, Finnland, 50100
- GSK Investigational Site
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Rauma, Finnland, 26100
- GSK Investigational Site
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Tampere, Finnland, 33200
- 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
10 Jahre bis 18 Jahre (Kind, Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Männlich
Beschreibung
Inclusion criteria:
- A male between, and including, 10 and 18 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, a written informed consent must be obtained from the subject's parent/guardian. In addition, a written informed assent must be obtained from the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria:
- Previous vaccination against Human Papillomavirus (HPV).
- Previous vaccination against Hepatitis B, known clinical history of Hepatitis B infection.
- Cancer or autoimmune disease under treatment.
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: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Cervarix Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule.
The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
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All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule.
Andere Namen:
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Aktiver Komparator: Engerix-B Group
Healthy male subjects between and including 10 to 18 years of age at the time of the first vaccination, who were administered 3 doses of Engerix-B™ (HBV) vaccine, intramuscularly into the deltoid region of the non-dominant arm, according to a 0, 1 and 6-month schedule.
The subjects were followed up for 7 months after the first dose and an additional telephone contact was foreseen at Month 12.
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All subjects received an intramuscular injection into the deltoid of the non-dominant arm according to a 0, 1 and 6-month schedule
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Zeitfenster: At Month 7
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies [anti-HPV-16 titers greater than or equal to (≥) 8 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) and anti-HPV-18 titres ≥7 EL.U/mL] in the serum of subjects seronegative before vaccination.
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At Month 7
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Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Zeitfenster: At Month 7
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Titers were presented as geometric mean titers (GMT).
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At Month 7
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Zeitfenster: At Month 2
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Seroconversion was defined as the appearance of anti-HPV-16 and/or anti-HPV-18 antibodies (anti-HPV-16 titres ≥ 8 EL.U/mL and anti-HPV-18 titres ≥ 7 EL.U/mL) in the serum of subjects seronegative before vaccination.
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At Month 2
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Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Zeitfenster: At Month 2
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Titers were presented as GMTs.
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At Month 2
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Zeitfenster: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Solicited local symptoms assessed were pain, redness and swelling.
Any = any solicited local symptom irrespective of intensity grade; Grade 3 pain = pain that prevented normal activity; Grade 3 redness/swelling = redness/swelling spreading beyond (>) 50 mm.
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Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Solicited general symptoms assessed were arthralgia, fatigue, fever (defined as axillary temperature ≥37.5 °C), gastrointestinal, headache, myalgia, rash and urticaria.
Any = any solicited general symptom irrespective of intensity grade or relationship to vaccination; Grade 3 = symptom that prevented normal activity; Grade 3 fever = temperature > 39.0 °C; Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Zeitfenster: Within 30 days (Day 0-29) after any vaccination, up to 7 months
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An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 AE = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to the vaccination.
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Within 30 days (Day 0-29) after any vaccination, up to 7 months
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Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Zeitfenster: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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NOCDs include asthma, Chron's disease, dermatitis atopic.
MSCs include AEs prompting emergency room or physician visits that are not related to common diseases or routine visits for physical examination or vaccination, or serious adverse events (SAEs) that are not related to common diseases.
Common diseases include upper respiratory infections, sinusitis, pharyngitis, gastroenteritis, urinary tract infections and injury.
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Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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Number of Subjects With Serious Adverse Events (SAEs)
Zeitfenster: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
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Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Zeitfenster: At Month 2 and Month 7, post-vaccination
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The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: alanine aminotransferase [ALT], basophils [BAS], creatinine [CREA], eosinophils [EOS] and hematocrit [Hem].
Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
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At Month 2 and Month 7, post-vaccination
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Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Zeitfenster: At Month 2 and at Month 7, post-vaccination
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The occurence of clinically relevant abnormalities was assessed in the following biochemical and haematological parameters: lymphocytes [LYM], monocytes [MON], neutrophils [NEU], platelets [PLA], red blood cells [RBC] and white blood cells [WBC].
Levels of haematological/biochemical parameters assessed in terms of normal, below and above laboratory values were - normal, below, above and missing.
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At Month 2 and at Month 7, post-vaccination
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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
- Verstraeten T, Descamps D, David MP, Zahaf T, Hardt K, Izurieta P, Dubin G, Breuer T. Analysis of adverse events of potential autoimmune aetiology in a large integrated safety database of AS04 adjuvanted vaccines. Vaccine. 2008 Dec 2;26(51):6630-8. doi: 10.1016/j.vaccine.2008.09.049.
- Petaja T, Keranen H, Karppa T, Kawa A, Lantela S, Siitari-Mattila M, Levanen H, Tocklin T, Godeaux O, Lehtinen M, Dubin G. Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years. J Adolesc Health. 2009 Jan;44(1):33-40. doi: 10.1016/j.jadohealth.2008.10.002.
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)
5. April 2006
Primärer Abschluss (Tatsächlich)
1. Juni 2007
Studienabschluss (Tatsächlich)
19. Juni 2007
Studienanmeldedaten
Zuerst eingereicht
28. März 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
28. März 2006
Zuerst gepostet (Schätzen)
31. März 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
17. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Februar 2018
Zuletzt verifiziert
1. Februar 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 580299/011
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
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Klinischer Studienbericht
Informationskennung: 580299/011Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 580299/011Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einwilligungserklärung
Informationskennung: 580299/011Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 580299/011Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 580299/011Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 580299/011Informationskommentare: 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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