- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00385840
Study to Evaluate the Immunogenicity and Safety of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate
9 maggio 2018 aggiornato da: GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of a Second Vaccination With the Adjuvanted Influenza Vaccine Candidate Compared to Fluarix™ Administered Intramuscularly in Elderly Aged 60 Years and Above.
The purpose of this study is to evaluate the immunogenicity and the safety of a second vaccination with candidate vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years and above
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
678
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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Elverum, Norvegia, 2408
- GSK Investigational Site
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Hamar, Norvegia, 2301
- GSK Investigational Site
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Paradis, Norvegia, 5231
- 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
60 anni e precedenti (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- A male or female age 60 years or older at the time of the revaccination, who previously participated in 107192 & 107214 clinical trials.
- Subjects who the investigator believes can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration 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 30 days after vaccination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of confirmed influenza infection within the last 12 months.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
- Acute disease at the time of enrolment.
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: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore attivo: Fluarix Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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Single dose, intramuscular injection
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Sperimentale: GSK1247446A Group
Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study.
The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
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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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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Lasso di tempo: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited local symptoms were ecchymosis, pain, redness and swelling.
Any = Incidence of a particular solicited local symptom regardless of intensity grade.
Grade 3 pain = Pain that prevented normal everyday activity.
Grade 3 redness/swelling/ecchymosis = Redness/swelling/ecchymosis above 50 millimeters (mm).
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Lasso di tempo: During the 7-day (Days 0-6) post-vaccination period
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Assessed solicited general symptoms were arthralgia, fatigue, fever, headache, muscle aches and shivering.
Any = Incidence of a particular solicited general symptom regardless of intensity grade or relationship with the study vaccination.
Any Fever = Axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C).
Grade 3 symptom = Symptom that prevented normal activity.
Grade 3 fever = Axillary temperature > 39.0°C.
Related = Symptom considered by the investigator to have a causal relationship to study vaccination.
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During the 7-day (Days 0-6) post-vaccination period
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Lasso di tempo: During the 30-day (Days 0-29) post vaccination period
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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 = Any unsolicited AE regardless of intensity or relationship to vaccination.
Grade 3 = Unsolicited AE that prevented normal activity.
Related = Unsolicited AE assessed by the investigator as causally related to the vaccination.
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During the 30-day (Days 0-29) post vaccination period
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Lasso di tempo: During the entire study period (from Day 0 to Day 29)
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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 SAE = Occurrence of any SAE regardless of intensity grade or relation to vaccination Related = SAE considered by the investigator to have a causal relationship to study vaccination.
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During the entire study period (from Day 0 to Day 29)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Lasso di tempo: At Day 21
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A seroconverted subject was defined as a vaccinated 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 four-fold increase in post-vaccination titer.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Lasso di tempo: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40.
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 0 and Day 21
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Lasso di tempo: At Day 21
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
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At Day 21
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Lasso di tempo: At Day 0 and Day 21
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Titers are presented as geometric mean titers (GMTs).
The 3 influenza strains assessed were A/New Caledonia, A/Wisconsin and B/Malaysia.
The seropositivity cut-off assay was 1:10.
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At Day 0 and Day 21
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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 ottobre 2006
Completamento primario (Effettivo)
1 febbraio 2007
Completamento dello studio (Effettivo)
5 febbraio 2007
Date di iscrizione allo studio
Primo inviato
10 ottobre 2006
Primo inviato che soddisfa i criteri di controllo qualità
10 ottobre 2006
Primo Inserito (Stima)
11 ottobre 2006
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 ottobre 2016
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 108708
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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Set di dati del singolo partecipante
Identificatore informazioni: 108708Commenti 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: 108708Commenti 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: 108708Commenti 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: 108708Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 108708Commenti 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: 108708Commenti 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 .