A Randomized Study to Compare the Safety and Immunogenicity of Fluviral® Made With New Versus Aged Bulk
13 giugno 2019 aggiornato da: GlaxoSmithKline
Observer-blind, Post-Marketing Study to Compare the Safety and Immunogenicity of Fluviral® Trivalent Split Virion Influenza Vaccine (2007-2008 Season) Made With New vs. Aged Bulk Material, in Adults Ranging in Age From 18 to 60 Years
Vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk.
Once a year, a meeting of World Health Organization (WHO) experts takes place, leading to a recommendation on the influenza A and B strains that should be used for the production of vaccine for the coming influenza season. For the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year.
Bulks as old as 12 months may be blended to make trivalent inactivated vaccine (TIV) under the current Canadian and US licenses. This study is conducted to evaluate safety and immunogenicity of Fluviral vaccines made with the aged bulk material compared with the new bulk material. This protocol posting has been updated in order to comply with the FDA Amendment Act, Sept 2007.
Panoramica dello studio
Tipo di studio
Interventistico
Iscrizione (Effettivo)
1000
Fase
- Fase 4
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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Quebec, Canada, G1W 4R4
- GSK Investigational Site
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British Columbia
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Coquitlam, British Columbia, Canada, V3K 3P4
- GSK Investigational Site
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Newfoundland and Labrador
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Bay Roberts, Newfoundland and Labrador, Canada, A0A 1G0
- GSK Investigational Site
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Ontario
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Toronto, Ontario, Canada, M9W 4L6
- GSK Investigational Site
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Toronto, Ontario, Canada, M1L 4S4
- GSK Investigational Site
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Quebec
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Gatineau, Quebec, Canada, J8Y 6S8
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 4J6
- GSK Investigational Site
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Sherbrooke, Quebec, Canada, J1H 1Z1
- 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
Da 18 anni a 60 anni (Adulto)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
Inclusion Criteria:
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- Male and female adults, 18 to 60 years.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study.
Exclusion Criteria:
- Acute disease at the time of enrollment.
- Any confirmed or suspected immunosuppressive condition
- Presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- A history of any demyelinating disease including Guillain-Barré syndrome.
- Presence of an active neurological disorder.
- Any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin.
- Receipt of an influenza vaccine within 6 months prior to study enrollment.
- Administration of any vaccines within 30 days prior to study enrollment or during the study period.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
- Any known or suspected allergy to any constituent of Fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury.
- A history of severe adverse reaction to a previous influenza vaccination.
- Lactating/nursing female.
- Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
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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Sperimentale: Old Bulk
This group receives a full dose of Fluviral made from aged bulk material
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One dose, Intramuscular injection
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Comparatore attivo: New Bulk
This group receives a full dose of Fluviral made from new material
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One 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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Geometric Mean Titers (GMTs) of Anti-H3 and B Strains
Lasso di tempo: At Day 21
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GMTs for H1 strain is addressed as a secondary endpoint
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At Day 21
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Geometric Mean Titers (GMTs) of the H1 Strain and the GMT of the H3 and B Strains
Lasso di tempo: At Days 0 and 21
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The table contains GMTs of the H1 strains at Day 0 & 21 and of the H3 and B strains at Day 0 (values at Day 21 for H3 and B strains were primary outcome measures)
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At Days 0 and 21
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Number of Participants Who Seroconverted.
Lasso di tempo: At Day 21.
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The table shows the number of participants who have either a pre-vaccination titer < 1:10 and a post-vaccination titer >= 1:40 or a prevaccination titer >= 1:10 and at least a 4-fold increase in post-vaccination titer, at Day 21.
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At Day 21.
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Number of Seroprotected Participants.
Lasso di tempo: At Days 0 and 21
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The table presents the number of participants with a serum haemagglutination inhibition (HI) titer >= 1:40 that usually is accepted as indicating protection.
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At Days 0 and 21
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Seroconversion Factors Defined as the Fold Increase in Serum HI GMTs Post-vaccination for Influenza Antigen H1N1
Lasso di tempo: At Day 21 compared to Day 0
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Seroconversion factors are defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0, at Day 21.
This table presents the SCF for the H1 strain.
The SCF for the other strains are addressed in the next table.
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At Day 21 compared to Day 0
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The Fold Increase in Anti-HI GMTs for Influenza Antigens H3 and B
Lasso di tempo: At Day 21 compared to Day 0
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The fold increase in anti-HI GMTs for influenza antigen H1 is presented in the previous table.
The "fold increase" corresponds to the Unit of Measure "Factor."
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At Day 21 compared to Day 0
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Number of Participants Reporting Solicited Local Symptoms
Lasso di tempo: During the 4-day follow up period following vaccination.
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Solicited local symptoms assessed include pain, redness and swelling.
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During the 4-day follow up period following vaccination.
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Number of Participants Reporting Solicited General Symptoms
Lasso di tempo: During the 4-day period following each vaccination.
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Solicited general symptoms assessed include bronchospasm, chills, cough, fatigue, fever, headache, joint pain at other location, muscle aches, red eyes, sore throat, and swelling of the face
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During the 4-day period following each vaccination.
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Number of Participants Reporting Unsolicited Adverse Events (AE).
Lasso di tempo: During the 21-day period following each vaccination.
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An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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During the 21-day period following each vaccination.
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Number of Participants Reporting Serious Adverse Events (SAE)
Lasso di tempo: Within 21 days after vaccination
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An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.
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Within 21 days 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 (Effettivo)
14 dicembre 2007
Completamento primario (Effettivo)
14 gennaio 2008
Completamento dello studio (Effettivo)
14 gennaio 2008
Date di iscrizione allo studio
Primo inviato
21 dicembre 2007
Primo inviato che soddisfa i criteri di controllo qualità
21 dicembre 2007
Primo Inserito (Stima)
4 gennaio 2008
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
27 giugno 2019
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 giugno 2019
Ultimo verificato
1 giugno 2019
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 111258
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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Modulo di segnalazione del caso annotato
Identificatore informazioni: 111258Commenti 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: 111258Commenti 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: 111258Commenti 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: 111258Commenti 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: 111258Commenti 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: 111258Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 111258Commenti 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 .