Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over
9 maggio 2018 aggiornato da: GlaxoSmithKline
Non-Inferiority of GlaxoSmithKline Biologicals' Influenza Vaccine (GSK576389A) 1 Container Over 2 Container Presentation in Adults Aged 65 Years and Over
This observer blind study is designed to compare the immune response of GSK Biologicals' influenza vaccine GSK576389A when administered using various presentations in adults aged 65 years and older.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
The study contains 6 parallel groups, stratified by two age groups: 65-74 years and ≥ 75 years and by two influenza vaccination histories: no influenza vaccination in the last 3 seasons and at least one influenza vaccination in the last 3 seasons.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1596
Fase
- Fase 2
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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Soeborg, Danimarca, 2860
- GSK Investigational Site
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Tartu, Estonia, 50417
- GSK Investigational Site
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Bergen, Norvegia, 5094
- GSK Investigational Site
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Elverum, Norvegia, 2408
- GSK Investigational Site
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Hamar, Norvegia, 2317
- GSK Investigational Site
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Stavanger, Norvegia, 4010
- 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
65 anni e precedenti (Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female aged 65 years or older at the time of the vaccination.
- 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.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) 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 a vaccine not foreseen by the study protocol up to Visit 2 after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Vaccination against influenza since January 2007 (including the Northern Hemisphere NH 2006/2007 or NH 2007/08 influenza vaccine).
- Chronic administration (defined as more than 14 days) 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 (no laboratory testing required).
- 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 or renal functional abnormality, as determined by clinical evaluation or pre-existing laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or planned administration during the study.
- Any medical conditions in which intramuscular injections are contraindicated.
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: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: GSK576389A- 2006/2007 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Sperimentale: GSK576389A - 2006/2007 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Comparatore attivo: Fluarix 2006/2007 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
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Sperimentale: GSK576389A - 2007/2008 Season - 1 container Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Sperimentale: GSK576389A - 2007/2008 Season - 2 containers Group
Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
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Single dose, intramuscular injection, GSK Bio's influenza vaccine GSK576389A formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Comparatore attivo: Fluarix 2007/2008 Season Group
Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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Single dose, intramuscular injection, Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
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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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Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain
Lasso di tempo: At Days 0 and 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The H1N1 vaccine strains included A/New Caledonia and A/Solomon Islands antigens.
A/New Caledonia vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season.
A/Solomon Islands vaccine strain was administered to both groups receiving the adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season.
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At Days 0 and 21
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Durata degli eventi avversi locali sollecitati
Lasso di tempo: Durante un periodo di follow-up di 7 giorni (giorno 0-6) dopo la vaccinazione
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La durata è stata definita come il numero di giorni con qualsiasi grado di sintomi locali.
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Durante un periodo di follow-up di 7 giorni (giorno 0-6) dopo la vaccinazione
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Durata degli eventi avversi generici sollecitati
Lasso di tempo: Durante un periodo di follow-up di 7 giorni (giorno 0-6) dopo la vaccinazione
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La durata è stata definita come il numero di giorni con qualsiasi grado di sintomi generali.
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Durante un periodo di follow-up di 7 giorni (giorno 0-6) dopo la vaccinazione
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Numero di soggetti che hanno segnalato eventi avversi non richiesti di grado 3 e correlati
Lasso di tempo: Durante un periodo di follow-up di 21 giorni (giorno 0-20) dopo la vaccinazione
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Gli eventi avversi non richiesti coprono qualsiasi evento avverso segnalato in aggiunta a quelli sollecitati durante lo studio clinico e qualsiasi sintomo sollecitato con insorgenza al di fuori del periodo di follow-up specificato per i sintomi sollecitati.
Qualsiasi è stato definito come il verificarsi di qualsiasi sintomo non richiesto indipendentemente dal grado di intensità o dalla relazione con la vaccinazione.
Il grado 3 è stato un evento che ha impedito le normali attività e correlato è stato definito come un evento avverso non richiesto valutato dallo sperimentatore come causalmente correlato alla vaccinazione in studio.
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Durante un periodo di follow-up di 21 giorni (giorno 0-20) dopo la vaccinazione
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HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations
Lasso di tempo: At Days 0 and 21
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Antibody titers were expressed as GMTs.
The vaccine strains included A/New Caledonia or A/Solomon Islands, A/Wisconsin and B/Malaysia antigens.
A/New Caledonia vaccine strain was administered to all groups receiving the Northern Hemisphere 2006/2007 influenza season vaccine formulations.
A/Solomon Islands vaccine strain was administered to all groups receiving the Northern Hemisphere 2007/2008 influenza season vaccine formulations.
A/Wisconsin and B/Malaysia vaccine strains were administered to all groups.
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At Days 0 and 21
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The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Lasso di tempo: At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a 4-fold increase in post-vaccination titer.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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HI Antibody Seroconversion Factors
Lasso di tempo: At Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Day 21
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The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations
Lasso di tempo: At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
The vaccine strains included A/New Caledonia (for all groups receiving vaccine formulations for the Northern Hemisphere [NH] 2006/2007 influenza season) or A/Solomon Islands (for all groups receiving vaccine formulations for the NH 2007/2008 influenza season), A/Wisconsin and B/Malaysia antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Lasso di tempo: During a 7-day follow-up period (Day 0-6) after vaccination
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Grade 3 ecchymosis, redness and swelling was greater than 100 millimeter (mm) i.e. >100mm and grade 3 pain was considerable pain at rest that prevented normal everyday activities.
Any was occurrence of any local symptom regardless of their intensity grade.
Any for ecchymosis, redness and swelling was >20mm.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs
Lasso di tempo: During a 7-day follow-up period (Day 0-6) after vaccination
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Any temperature was defined as oral temperature greater than or equal to 38.0 degree centigrade i.e ≥38.0°C, grade 3 temperature was oral temperature ≥39.0°C.
For other symptoms, any was defined as occurrence of any general symptom regardless of intensity grade or relation to vaccination and grade 3 was defined as a general symptom that prevented normal activity.
Related was a general symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day follow-up period (Day 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Lasso di tempo: During a 21-day follow-up period (Day 0-20) after vaccination
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MSCs were defined as an AEs with a medically-attended visit (MAE) i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
Any MSC was defined as at least one MSC experienced.
Grade 3 was a MSC that prevented normal activities and related was defined as a MSC assessed by the investigator to be causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Lasso di tempo: During a 21-day follow-up period (Day 0-20) after vaccination
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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 or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During a 21-day follow-up period (Day 0-20) after vaccination
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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
20 settembre 2007
Completamento primario (Effettivo)
1 novembre 2007
Completamento dello studio (Effettivo)
2 novembre 2007
Date di iscrizione allo studio
Primo inviato
19 settembre 2007
Primo inviato che soddisfa i criteri di controllo qualità
19 settembre 2007
Primo Inserito (Stima)
20 settembre 2007
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
8 giugno 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 maggio 2018
Ultimo verificato
1 novembre 2016
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 110620
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
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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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Modulo di segnalazione del caso annotato
Identificatore informazioni: 110620Commenti 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: 110620Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 110620Commenti 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: 110620Commenti 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: 110620Commenti 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: 110620Commenti 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: 110620Commenti 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 .