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- Klinische proef NCT01295320
Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects
Long Term Immunogenicity and Safety of GSK Biologicals' Herpes Zoster Vaccine 1437173A in Healthy Subjects
The subjects included in this study are subjects that participated in study NCT00434577. These subjects were vaccinated with the candidate Herpes Zoster (HZ) vaccine at Month 0 and Month 2 and were then followed at Month 12, Month 24 and Month 36 (study NCT00434577) for safety and immunogenicity.
This long term follow up study (ZOSTER-024 [114825]) will evaluate immune responses to and safety of the previously administered candidate HZ vaccine at Months 48, 60 and 72.
The study visits will be scheduled at approximately one year intervals after the first visit in ZOSTER-024. Blood samples for the evaluation of cellular and humoral immunity will be taken from all subjects at each visit. Information on safety and the occurrence of HZ will also be collected during these visits.
Studie Overzicht
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Berlin, Duitsland, 13347
- GSK Investigational Site
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Baden-Wuerttemberg
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Mannheim, Baden-Wuerttemberg, Duitsland, 68161
- GSK Investigational Site
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Bayern
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Wuerzburg, Bayern, Duitsland, 97070
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Duitsland, 30625
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Duitsland, 45359
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Duitsland, 51069
- GSK Investigational Site
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Amsterdam, Nederland, 1018 WT
- GSK Investigational Site
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Rotterdam, Nederland, 3011 EN
- GSK Investigational Site
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Hradec Kralove, Tsjechië, 500 01
- GSK Investigational Site
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Eskilstuna, Zweden, SE-631 88
- GSK Investigational Site
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Uppsala, Zweden, SE-751 85
- GSK Investigational Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Previous participation in study NCT00434577 as a member of the intermediate dose active vaccine group
- Written informed consent obtained from the subject
Exclusion Criteria:
- Having participated in another study at any time after NCT00434577 study end in which the subject was exposed to an investigational or non-investigational product or; 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
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first blood draw
- Having received a vaccine containing some vaccine components, any time after study end of study NCT00434577
- Having received a vaccine against HZ any time after study end of study NCT00434577
- Subject who did not receive a complete vaccination course of 2 doses of the intermediate dose active vaccine in study NCT00434577
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: GSK1437173A Group
Subjects who received 2 doses of HZ vaccine in the intermediate dose study group in study 108494 (NCT00434577).
No treatment was given in this current study (NCT01295320).
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Blood sample will be collected at Month 48, Month 60 and Month 72
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tijdsspanne: Month 48
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-Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 48
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tijdsspanne: Month 60
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Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 60
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Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tijdsspanne: Month 72
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Frequencies of CD4 T cells with antigen-specific Interferon gamma (IFN-γ) and/or Interleukin-2 (IL-2) and/or Tumour Necrosis Factor alpha (TNF-α) and/or CD40 Ligand (CD40L) secretion/expression to glycoprotein E (gE) and Varicella Zoster Virus (VZV) as determined by Intracellular Cytokine Staining (ICS)
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Month 72
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Antigen-specific Antibody (Ab) Concentrations
Tijdsspanne: Month 48
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 48
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Antigen-specific Antibody (Ab) Concentrations
Tijdsspanne: Month 60
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 60
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Antigen-specific Antibody (Ab) Concentrations
Tijdsspanne: Month 72
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-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
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Month 72
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
Tijdsspanne: Month 48 to Month 72
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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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Month 48 to Month 72
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Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
Tijdsspanne: Month 0 to Month 72
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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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Month 0 to Month 72
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Number of Subjects With Any Fatal SAEs
Tijdsspanne: Month 48 to Month 72
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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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Month 48 to Month 72
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Number of Subjects With Any Suspected Cases of HZ Episodes
Tijdsspanne: Month 48 to Month 72
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Month 48 to Month 72
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Number of Subjects With Any Suspected Cases of HZ Episodes Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
Tijdsspanne: Month 48 to Month 72
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Month 48 to Month 72
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Number of Subjects and Relationship to Vaccination of Any Potential Immune Mediated Diseases (pIMDs) Following Participation in 108494 Study and Its Follow-ups (108516, 108518 and 108520) and Not Already Documented
Tijdsspanne: Month 48 to Month 72
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Month 48 to Month 72
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Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 114825
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Bestudeer gegevens/documenten
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Specificatie gegevensset
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisch analyseplan
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Geannoteerd casusrapportformulier
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Klinisch onderzoeksrapport
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Leerprotocool
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Gegevensset individuele deelnemers
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
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Formulier geïnformeerde toestemming
Informatie-ID: 114825Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Herpes zoster
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GlaxoSmithKlineVoltooidHerpes zoster | Herpes Zoster-vaccinCanada, Spanje, Korea, republiek van, Verenigd Koninkrijk, Frankrijk, Tsjechië
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Merck Sharp & Dohme LLCVoltooidHerpes zoster | Herpes Zoster-gerelateerde complicaties
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GlaxoSmithKlineVoltooidHerpes zoster | Herpes Zoster-vaccinVerenigde Staten, Estland, Canada
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Ohio State UniversityVoltooidHerpes Zoster-ziekteVerenigde Staten
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Northwestern UniversityBausch & Lomb IncorporatedBeëindigdHerpes Zoster-keratitisVerenigde Staten
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GlaxoSmithKlineVoltooidHerpes zoster | Herpes Zoster-vaccinVerenigde Staten, Canada, België
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GlaxoSmithKlineVoltooidHerpes zoster | Herpes Zoster-vaccinVerenigde Staten, Australië, Spanje, Finland, Duitsland, Japan, Taiwan, Canada, Zweden, Korea, republiek van, Tsjechië, Hongkong, Mexico, Italië, Brazilië, Estland, Frankrijk, Verenigd Koninkrijk
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Tanta UniversityNog niet aan het wervenPijnbestrijding bij acute herpes zoster
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Merck Sharp & Dohme LLCVoltooid
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Centrexion TherapeuticsBeëindigd
Klinische onderzoeken op Blood sample
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Hillel Yaffe Medical CenterOnbekend