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Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People

22. srpna 2018 aktualizováno: GlaxoSmithKline

Observer-blind Safety and Immunogenicity Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK2186877A When Administered to Elderly Subjects

The purpose of the study is to evaluate the safety of GSK Biologicals' influenza vaccine. Elderly subjects were randomized in the primary study (NCT00760617) and will now receive the same vaccine for the third time. For this study the masking is "observer-blind" for elderly subjects and "open" for young adult subjects.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Typ studie

Intervenční

Zápis (Aktuální)

370

Fáze

  • Fáze 3

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Holandsko
      • Rotterdam, Holandsko, 3011 EN
        • GSK Investigational Site
      • Rotterdam, Holandsko, 3011 AA
        • GSK Investigational Site
  • Německo
      • Berlin, Německo, 13347
        • GSK Investigational Site
      • Berlin, Německo, 12627
        • GSK Investigational Site
      • Berlin, Německo, 10435
        • GSK Investigational Site
      • Hamburg, Německo, 22415
        • GSK Investigational Site
      • Hamburg, Německo, 22335
        • GSK Investigational Site
    • Baden-Wuerttemberg
      • Gueglingen, Baden-Wuerttemberg, Německo, 74363
        • GSK Investigational Site
      • Mannheim, Baden-Wuerttemberg, Německo, 68161
        • GSK Investigational Site
      • Rudersberg, Baden-Wuerttemberg, Německo, 73635
        • GSK Investigational Site
      • Weinheim, Baden-Wuerttemberg, Německo, 69469
        • GSK Investigational Site
    • Bayern
      • Augsburg, Bayern, Německo, 86150
        • GSK Investigational Site
    • Nordrhein-Westfalen
      • Essen, Nordrhein-Westfalen, Německo, 45359
        • GSK Investigational Site
      • Koeln, Nordrhein-Westfalen, Německo, 51069
        • GSK Investigational Site
    • Rheinland-Pfalz
      • Mainz, Rheinland-Pfalz, Německo, 55131
        • GSK Investigational Site
      • Rhaunen, Rheinland-Pfalz, Německo, 55624
        • GSK Investigational Site
    • Sachsen
      • Dresden, Sachsen, Německo, 01067
        • GSK Investigational Site
      • Freital, Sachsen, Německo, 01705
        • GSK Investigational Site
      • Leipzig, Sachsen, Německo, 04103
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Německo, 39112
        • GSK Investigational Site
      • Wolmirstedt, Sachsen-Anhalt, Německo, 39326
        • GSK Investigational Site
  • Švédsko
      • Eskilstuna, Švédsko, SE-631 88
        • GSK Investigational Site
      • Karlskrona, Švédsko, SE-371 41
        • GSK Investigational Site
      • Uppsala, Švédsko, SE-751 85
        • GSK Investigational Site

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

19 let a starší (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ano

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

All subjects must satisfy ALL the following criteria at study entry:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study. Specific attention should be given to the compliance potential of subjects with suspected drug or alcohol abuse.
  • A male or female aged 19-43 years or >=66 years at the time of the vaccination and who participated in the study NCT00760617 and completed the 6-month follow-up.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation before entering into the study.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study if the subject:
  • has practiced adequate contraception for 30 days prior to vaccination, and
  • has a negative pregnancy test on the day of vaccination, and
  • has agreed to continue adequate contraception for 2 months after the vaccination.

Exclusion Criteria:

The following criteria should be checked at the time of study entry. If ANY exclusion criterion applies, the subject must not be included in the study:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days prior to vaccination, or planned use during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of an influenza vaccine other than the study vaccines or of a vaccine not foreseen in the study protocol during the entire study period.
  • Vaccination against influenza since January 2009 with a seasonal influenza vaccine.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the administration of the study vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s).
  • Acute clinically significant pulmonary, cardiovascular, hepatic, renal, neurological and psychiatric disorders, as determined by clinical evaluation or pre-existing laboratory screening tests.

  • Acute disease and/or fever at the time of enrolment.

    • Fever is defined as temperature >=37.5°C on oral setting.
    • Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned administration during the study.
  • Any medical conditions in which IM injections are contraindicated
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Prevence
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Čtyřnásobek

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: New generation influenza vaccine GSK2186877A Group
Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
Biologický: GSK investigational vaccine 2186877A
Single dose, intramuscular injection
Aktivní komparátor: Fluarix elderly Group
Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
Biologický: FluarixTM
Single dose, intramuscular injection
Aktivní komparátor: Fluarix young Group
Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
Biologický: FluarixTM
Single dose, intramuscular injection

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Doba trvání vyžádaných obecných AE
Časové okno: Den 0-6
Doba trvání byla definována jako počet dní s jakýmkoli stupněm celkových příznaků.
Den 0-6
Doba trvání vyžádaných místních AE
Časové okno: Den 0-6
Doba trvání byla definována jako počet dní s jakýmkoli stupněm lokálních symptomů.
Den 0-6
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Časové okno: Day 0-6
Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Časové okno: Day 0-6
Any fever was defined as oral temperature ≥ 38.0 degree centigrade (°C), grade 3 fever was oral temperature ≥ 39.0°C-≤ 40.0°C. For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade, grade 3 was defined as general symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Day 0-6
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Časové okno: Day 0-20
Unsolicited AE covers any AE 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 occurrence of any unsolicited symptom regardless of intensity grade, grade 3 was unsolicited symptom that prevented normal activity and related was event assessed by the investigator as causally related to the study vaccination.
Day 0-20
Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
Časové okno: Day 0-179
For each solicited and unsolicited AE the subject experienced, the subject was asked if they had received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel (medical doctor) for any reason. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Day 0-179
Number of Subjects Reporting AEs of Specific Interest (AESI)
Časové okno: Day 0-179
AESI for safety monitoring are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology. Any was defined as occurrence of any symptom regardless of intensity grade, grade 3 was defined as symptom that prevented normal activity and related was general symptom assessed by the investigator as causally related to the study vaccination.
Day 0-179
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
Časové okno: Up to Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
Up to Day 180
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
Časové okno: After Day 180
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade and related was event assessed by the investigator as causally related to the study vaccination.
After Day 180

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Časové okno: Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs) against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Day 0 and Day 21
HI Antibody Titers at Day 180
Časové okno: Day 180
Antibody titers were expressed as GMTs against separate vaccine strains. The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
Day 180
The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
Časové okno: Day 0 and Day 21
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
Day 0 and Day 21
The Number of Subjects Seropositive to HI Antibodies at Day 180
Časové okno: Day 180
Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
Day 180
The Number of Subjects Seroconverted to HI Antibodies at Day 21
Časové okno: Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Day 21
The Number of Subjects Seroconverted to HI Antibodies at Day 180
Časové okno: Day 180
A seroconverted subject was defined as a subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer.
Day 180
HI Antibody Seroconversion Factors (SCF) at Day 21
Časové okno: At Day 21
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
At Day 21
HI Antibody SCF at Day 180
Časové okno: At Day 180
SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
At Day 180
The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
Časové okno: At Day 0 and Day 21
A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.
At Day 0 and Day 21
The Number of Subjects Seroprotected to HI Antibodies at Day 180
Časové okno: At Day 180
A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
At Day 180
The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strains Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21
Časové okno: At Day 0 and Day 21
The markers assessed were Cluster of Differentiation 40 Ligand (CD40L), interleukin 2 (IL-2), tumour necrosis factor alpha (TNF-α) and interferon gamma (IFN-γ) and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
At Day 0 and Day 21
The GM Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Day 180
Časové okno: At Day 180
The markers assessed were CD40L, IL-2, TNF-α and IFN-γ and vaccine strains tested included A/Brisbane, A/Uruguay and B/Brisbane antigens.
At Day 180

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

GlaxoSmithKline

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia

15. října 2009

Primární dokončení (Aktuální)

27. května 2010

Dokončení studie (Aktuální)

27. května 2010

Termíny zápisu do studia

První předloženo

1. října 2009

První předloženo, které splnilo kritéria kontroly kvality

8. října 2009

První zveřejněno (Odhad)

9. října 2009

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

21. září 2018

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. srpna 2018

Naposledy ověřeno

1. května 2018

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 113094

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

ANO

Popis plánu IPD

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

Studijní data/dokumenty

  1. Protokol studie
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  2. Plán statistické analýzy
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  3. Soubor dat jednotlivých účastníků
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  4. Zpráva o klinické studii
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  5. Specifikace datové sady
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulář informovaného souhlasu
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formulář komentované zprávy o případu
    Identifikátor informace: 113094
    Komentáře k informacím: For additional information about this study please refer to the GSK Clinical Study Register

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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