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Evaluation of the Immunogenicity and Safety of GlaxoSmithKline Biologicals' HPV Vaccine in Young Males.

5 februari 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

270

Fase

  • Fase 2

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Finland
      • Kotka, Finland, 48100
        • GSK Investigational Site
      • Kouvola, Finland, 45100
        • GSK Investigational Site
      • Mikkeli, Finland, 50100
        • GSK Investigational Site
      • Rauma, Finland, 26100
        • GSK Investigational Site
      • Tampere, Finland, 33200
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

10 jaar tot 18 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Mannelijk

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Biologisch: Cervarix vaccine
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:
  • HPV-vaccin
Actieve vergelijker: 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.
Biologisch: Engerix-B vaccine
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:
  • HBV-vaccin

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Tijdsspanne: At Month 7
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.
At Month 7
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Tijdsspanne: At Month 7
Titers were presented as geometric mean titers (GMT).
At Month 7

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Seroconverted Subjects for Anti-HPV-16 and Anti-HPV-18
Tijdsspanne: At Month 2
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.
At Month 2
Antibody Titers Against HPV-16 (Anti-HPV-16) and HPV-18 (Anti-HPV-18)
Tijdsspanne: At Month 2
Titers were presented as GMTs.
At Month 2
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tijdsspanne: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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.
Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tijdsspanne: Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
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.
Within 7 days (Days 0-6) after each dose and across doses, up to 7 months
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tijdsspanne: Within 30 days (Day 0-29) after any vaccination, up to 7 months
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.
Within 30 days (Day 0-29) after any vaccination, up to 7 months
Number of Subjects With New Onset of Chronic Diseases (NOCDs) and Other Medically Significant Conditions
Tijdsspanne: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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.
Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of Subjects With Serious Adverse Events (SAEs)
Tijdsspanne: Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
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.
Throughout the active phase of the study (up to Month 7) and the extended safety follow-up (from Month 7 up to Month 12)
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Tijdsspanne: At Month 2 and Month 7, post-vaccination
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.
At Month 2 and Month 7, post-vaccination
Number of Subjects With Clinically Relevant Abnormalities in Biochemical and Haematological Parameters
Tijdsspanne: At Month 2 and at Month 7, post-vaccination
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.
At Month 2 and at Month 7, post-vaccination

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 april 2006

Primaire voltooiing (Werkelijk)

1 juni 2007

Studie voltooiing (Werkelijk)

19 juni 2007

Studieregistratiedata

Eerst ingediend

28 maart 2006

Eerst ingediend dat voldeed aan de QC-criteria

28 maart 2006

Eerst geplaatst (Schatting)

31 maart 2006

Updates van studierecords

Laatste update geplaatst (Werkelijk)

17 september 2018

Laatste update ingediend die voldeed aan QC-criteria

5 februari 2018

Laatst geverifieerd

1 februari 2018

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 580299/011

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Klinisch onderzoeksrapport
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Gegevensset individuele deelnemers
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formulier geïnformeerde toestemming
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specificatie gegevensset
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Statistisch analyseplan
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Leerprotocool
    Informatie-ID: 580299/011
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

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