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Study of Long Term Immune Responses and Safety of the GSK Herpes Zoster Vaccine in Healthy Subjects

23. oktober 2017 opdateret af: GlaxoSmithKline

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

129

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Holland
      • Amsterdam, Holland, 1018 WT
        • GSK Investigational Site
      • Rotterdam, Holland, 3011 EN
        • GSK Investigational Site
  • Sverige
      • Eskilstuna, Sverige, SE-631 88
        • GSK Investigational Site
      • Uppsala, Sverige, SE-751 85
        • GSK Investigational Site
  • Tjekkiet
      • Hradec Kralove, Tjekkiet, 500 01
        • GSK Investigational Site
  • Tyskland
      • Berlin, Tyskland, 13347
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Tyskland, 68161
        • GSK Investigational Site
    • Bayern
      • Wuerzburg, Bayern, Tyskland, 97070
        • GSK Investigational Site
    • Niedersachsen
      • Hannover, Niedersachsen, Tyskland, 30625
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Tyskland, 45359
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Tyskland, 51069
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

60 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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).
Procedure: Blood sample
Blood sample will be collected at Month 48, Month 60 and Month 72

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tidsramme: Month 48
-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)
Month 48
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tidsramme: Month 60
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)
Month 60
Cell-Mediated Immunity (CMI) in Terms of Frequencies of Antigen-specific CD4 T Cells
Tidsramme: Month 72
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)
Month 72
Antigen-specific Antibody (Ab) Concentrations
Tidsramme: Month 48
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 48
Antigen-specific Antibody (Ab) Concentrations
Tidsramme: Month 60
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 60
Antigen-specific Antibody (Ab) Concentrations
Tidsramme: Month 72
-Anti-Glicoprotein E (Anti-gE) and anti-VZV Ab concentrations as determined by Enzyme-Linked Immunosorbent Assay (ELISA)
Month 72

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Any Serious Adverse Events (SAEs) Related to the Study Participation
Tidsramme: Month 48 to Month 72
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.
Month 48 to Month 72
Number of Subjects With Any SAEs Related to Previous Vaccination and Not Already Documented
Tidsramme: Month 0 to Month 72
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.
Month 0 to Month 72
Number of Subjects With Any Fatal SAEs
Tidsramme: Month 48 to Month 72
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.
Month 48 to Month 72
Number of Subjects With Any Suspected Cases of HZ Episodes
Tidsramme: Month 48 to Month 72
Month 48 to Month 72
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
Tidsramme: Month 48 to Month 72
Month 48 to Month 72
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
Tidsramme: Month 48 to Month 72
Month 48 to Month 72

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

28. februar 2011

Primær færdiggørelse (Faktiske)

20. juni 2013

Studieafslutning (Faktiske)

20. juni 2013

Datoer for studieregistrering

Først indsendt

11. februar 2011

Først indsendt, der opfyldte QC-kriterier

11. februar 2011

Først opslået (Skøn)

14. februar 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. november 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. oktober 2017

Sidst verificeret

1. oktober 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 114825

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

Ja

IPD-planbeskrivelse

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

Studiedata/dokumenter

  1. Datasætspecifikation
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Statistisk analyseplan
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Annoteret sagsbetænkningsformular
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinisk undersøgelsesrapport
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Studieprotokol
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individuelt deltagerdatasæt
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formular til informeret samtykke
    Informations-id: 114825
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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