Study to Evaluate the Safety and Immunogenicity of GlaxoSmithKline Biologicals' Influenza Vaccine in Elderly People
22 agosto 2018 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
370
Fase
- Fase 3
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
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Berlin, Germania, 13347
- GSK Investigational Site
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Berlin, Germania, 12627
- GSK Investigational Site
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Berlin, Germania, 10435
- GSK Investigational Site
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Hamburg, Germania, 22415
- GSK Investigational Site
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Hamburg, Germania, 22335
- GSK Investigational Site
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Baden-Wuerttemberg
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Gueglingen, Baden-Wuerttemberg, Germania, 74363
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Germania, 68161
- GSK Investigational Site
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Rudersberg, Baden-Wuerttemberg, Germania, 73635
- GSK Investigational Site
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Weinheim, Baden-Wuerttemberg, Germania, 69469
- GSK Investigational Site
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Bayern
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Augsburg, Bayern, Germania, 86150
- GSK Investigational Site
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Nordrhein-Westfalen
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Essen, Nordrhein-Westfalen, Germania, 45359
- GSK Investigational Site
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Koeln, Nordrhein-Westfalen, Germania, 51069
- GSK Investigational Site
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Rheinland-Pfalz
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Mainz, Rheinland-Pfalz, Germania, 55131
- GSK Investigational Site
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Rhaunen, Rheinland-Pfalz, Germania, 55624
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Germania, 01067
- GSK Investigational Site
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Freital, Sachsen, Germania, 01705
- GSK Investigational Site
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Leipzig, Sachsen, Germania, 04103
- GSK Investigational Site
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Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Germania, 39112
- GSK Investigational Site
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Wolmirstedt, Sachsen-Anhalt, Germania, 39326
- GSK Investigational Site
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Rotterdam, Olanda, 3011 EN
- GSK Investigational Site
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Rotterdam, Olanda, 3011 AA
- GSK Investigational Site
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Eskilstuna, Svezia, SE-631 88
- GSK Investigational Site
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Karlskrona, Svezia, SE-371 41
- GSK Investigational Site
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Uppsala, Svezia, SE-751 85
- GSK Investigational Site
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
19 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Quadruplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: New generation influenza vaccine GSK2186877A Group
Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
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Single dose, intramuscular injection
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Comparatore attivo: Fluarix elderly Group
Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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Comparatore attivo: Fluarix young Group
Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
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Single dose, intramuscular injection
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Durata degli eventi avversi generici sollecitati
Lasso di tempo: Giorno 0-6
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La durata è stata definita come il numero di giorni con qualsiasi grado di sintomi generali.
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Giorno 0-6
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Durata degli eventi avversi locali sollecitati
Lasso di tempo: Giorno 0-6
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La durata è stata definita come il numero di giorni con qualsiasi grado di sintomi locali.
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Giorno 0-6
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Lasso di tempo: Day 0-6
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Grade 3 ecchymosis, redness and swelling was ≥ 100 millimeter (mm) and grade 3 pain was considerable pain at rest, that prevented normal everyday activities.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Lasso di tempo: Day 0-6
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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.
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Day 0-6
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs
Lasso di tempo: Day 0-20
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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.
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Day 0-20
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Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit
Lasso di tempo: Day 0-179
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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.
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Day 0-179
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Number of Subjects Reporting AEs of Specific Interest (AESI)
Lasso di tempo: Day 0-179
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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.
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Day 0-179
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) up to Day 180
Lasso di tempo: Up to Day 180
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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.
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Up to Day 180
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) After Day 180
Lasso di tempo: After Day 180
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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.
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After Day 180
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Haemagglutination Inhibition (HI) Antibody Titers at Days 0 and 21
Lasso di tempo: Day 0 and Day 21
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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.
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Day 0 and Day 21
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HI Antibody Titers at Day 180
Lasso di tempo: Day 180
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Antibody titers were expressed as GMTs against separate vaccine strains.
The vaccine strains included A/Brisbane, A/Uruguay and B/Brisbane antigens.
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Day 180
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The Number of Subjects Seropositive to HI Antibodies at Days 0 and 21
Lasso di tempo: Day 0 and Day 21
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 0 and Day 21
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The Number of Subjects Seropositive to HI Antibodies at Day 180
Lasso di tempo: Day 180
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Seropositivity was defined as antibody titer greater than or equal to the cut-off value i.e ≥ 1:10.
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Day 180
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The Number of Subjects Seroconverted to HI Antibodies at Day 21
Lasso di tempo: Day 21
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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.
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Day 21
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The Number of Subjects Seroconverted to HI Antibodies at Day 180
Lasso di tempo: Day 180
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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.
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Day 180
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HI Antibody Seroconversion Factors (SCF) at Day 21
Lasso di tempo: At Day 21
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 21
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HI Antibody SCF at Day 180
Lasso di tempo: At Day 180
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SCF was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.
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At Day 180
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The Number of Subjects Seroprotected to HI Antibodies at Days 0 and 21
Lasso di tempo: At Day 0 and Day 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥ to 1:40 that usually is accepted as indicating protection.
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At Day 0 and Day 21
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The Number of Subjects Seroprotected to HI Antibodies at Day 180
Lasso di tempo: At Day 180
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A seroprotected subject was defined as a subject with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection.
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At Day 180
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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
Lasso di tempo: At Day 0 and Day 21
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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.
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At Day 0 and Day 21
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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
Lasso di tempo: At Day 180
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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.
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At Day 180
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
15 ottobre 2009
Completamento primario (Effettivo)
27 maggio 2010
Completamento dello studio (Effettivo)
27 maggio 2010
Date di iscrizione allo studio
Primo inviato
1 ottobre 2009
Primo inviato che soddisfa i criteri di controllo qualità
8 ottobre 2009
Primo Inserito (Stima)
9 ottobre 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
21 settembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
22 agosto 2018
Ultimo verificato
1 maggio 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 113094
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Dati/documenti di studio
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Protocollo di studio
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Piano di analisi statistica
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Set di dati del singolo partecipante
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Rapporto di studio clinico
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Specifica del set di dati
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di consenso informato
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Modulo di segnalazione del caso annotato
Identificatore informazioni: 113094Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .