- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01884519
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine, Fluarix®/Influsplit SSW® (2013/2014 Season), in Adults 18 Years of Age and Older
9 agosto 2018 aggiornato da: GlaxoSmithKline
Study for Evaluation of Immunogenicity and Reactogenicity of Fluarix/Influsplit SSW 2013/2014 in People 18 Years of Age and Above
The purpose of this study is to assess, in adults 18 years of age and above, the immunogenicity and reactogenicity of the seasonal influenza vaccine, Fluarix/Influsplit SSW 2013/2014, containing the three vaccine influenza strains (two A strains and one B strain) for the 2013/2014 season.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
120
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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Sachsen
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Dresden, Sachsen, Germania, 01307
- GSK Investigational Site
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Freiberg, Sachsen, Germania, 09599
- GSK Investigational Site
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Freital, Sachsen, Germania, 01705
- GSK Investigational Site
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Schmiedeberg, Sachsen, Germania, 01762
- 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
18 anni e precedenti (Adulto, Adulto più anziano)
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.
- A male or female aged 18 years or above at the time of vaccination.
- Written informed consent obtained from the subject.
- Healthy subjects or subjects with well-controlled chronic diseases as established by medical history and clinical examination before entering 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 during the entire treatment period and for 2 months after completion of vaccination.
Exclusion Criteria:
- Participation in previous year's Fluarix registration study (116663).
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within the six months prior to vaccination. Inhaled and topical steroids are allowed.
- Any administration of a long-acting immune-modifying drug within 6 months before study start, or planned administration 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 administration during the study period.
- Administration of an influenza vaccine within the twelve months preceding the study vaccination.
- Receipt of a vaccine other than the study vaccine within 30 days before study vaccination and/or plan to receive any vaccine other than the study vaccine during the entire study period.
- Clinically or virologically confirmed influenza infection within the six months preceding the study vaccination.
Acute disease and/or fever at the time of enrollment.
- Fever is defined as temperature ≥ 37.5°C/99.5°F on oral, axillary or tympanic setting, or ≥ 38.0°C/100.4°F on rectal setting. The preferred route for recording temperature in this study will be axillary.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Acute, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Chronic underlying disease (such as cancer, chronic obstructive pulmonary disease under oxygen therapy, insulin-dependent diabetes mellitus), not stabilized or clinically serious.
- History of chronic alcohol consumption and/or drug abuse.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of Guillain-Barré syndrome.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine including latex.
- Anaphylaxis following the administration of vaccine(s).
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study or would make intramuscular injection unsafe.
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: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: Fluarix/Influsplit 18-60 Years Group
Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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Sperimentale: Fluarix/Influsplit > 60 Years Group
Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
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1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibody Titers Against Each of the Three Vaccine Influenza Strains
Lasso di tempo: At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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At Day 0 and Day 21
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Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 0 and Day 21
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A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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At Day 0 and Day 21
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Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 21
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A seroconverted subjects was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 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.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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At Day 21
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Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 21
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MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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At Day 21
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Number of Subjects With Seroprotection Power (SPP) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains Above the Cut-off Value.
Lasso di tempo: At Day 21
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SPP was defined as the number of vaccinated subjects with a pre-vaccination titer < 1:40 and a post-vaccination titer ≥ 1:40.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
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At Day 21
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Humoral Immune Response in Terms of HI Antibody Titers Against Each of the Three Vaccine Influenza Strains
Lasso di tempo: At Days 0 and 21
|
Antibody titers were expressed as Geometric mean titers (GMTs).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
|
At Days 0 and 21
|
Number of Subjects Who Were Seroprotected for Anti-HI Antibodies Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 0 and Day 21
|
A seroprotected subject was defined as a vaccinated subject with a serum HI titer greater than or equal to (≥) 1:40 that usually is accepted as indicating protection in adults.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
|
At Day 0 and Day 21
|
Number of Seroconverted Subjects for Anti-HA Antibodies Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 21
|
A seroconverted subject was defined as a vaccinated subject with either a pre-vaccination titer less than (<) 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.
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
|
At Day 21
|
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibody Titer Against Each of the Three Vaccine Influenza Strains.
Lasso di tempo: At Day 21
|
MGI was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination (Day 0).
The vaccine strains assessed were Flu A/Christchurch/16/2010 (H1N1), Flu A/Texas/50/2012 (H3N2) and Flu B/Massachusetts/2/2012 (Yamagata).
This outcome measure was assessed by influenza vaccination status in subjects (18-60 years and >60 years) who had and who had not received an influenza vaccine during the 2 influenza seasons prior to season 2012/2013.
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At Day 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Lasso di tempo: During the 4-day (Days 0-3) post-vaccination period
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Solicited local symptoms assessed were ecchymosis, induration, pain, redness and swelling.
Any was defined as any solicited local symptom reported irrespective of intensity.
Grade 3 pain was defined as pain that prevented normal everyday activities.
Grade 3 ecchymosis, induration, redness and swelling was greater than 100 millimeters (mm) i.e. >100mm.
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During the 4-day (Days 0-3) post-vaccination period
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Duration of Solicited Local Symptoms.
Lasso di tempo: During the 4-day (Days 0-3) post-vaccination period
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Duration was defined as number of days with any grade of local symptoms.
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During the 4-day (Days 0-3) post-vaccination period
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Lasso di tempo: During the 4-day (Days 0-3) post-vaccination period
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Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, increased sweating and fever [axillary temperature above 37.5 degrees Celsius (°C)].
Gastrointestinal symptoms included nausea, vomiting, diarrhea and/or abdominal pain.
Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Grade 3 symptoms = symptoms that prevented normal activity.
Grade 3 fever = axillary temperature above 39.0°C
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During the 4-day (Days 0-3) post-vaccination period
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Duration of Solicited General Symptoms.
Lasso di tempo: During the 4-day (Days 0-3) post-vaccination period
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Duration was defined as number of days with any grade of general symptoms.
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During the 4-day (Days 0-3) post-vaccination period
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Lasso di tempo: During the 21-day (Days 0-20) 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
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During the 21-day (Days 0-20) post-vaccination period
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Lasso di tempo: During the entire study period (Days 0-180)
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A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was 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 the entire study period (Days 0-180)
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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
1 luglio 2013
Completamento primario (Effettivo)
2 agosto 2013
Completamento dello studio (Effettivo)
2 agosto 2013
Date di iscrizione allo studio
Primo inviato
13 giugno 2013
Primo inviato che soddisfa i criteri di controllo qualità
20 giugno 2013
Primo Inserito (Stima)
24 giugno 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
7 settembre 2018
Ultimo aggiornamento inviato che soddisfa i criteri QC
9 agosto 2018
Ultimo verificato
1 giugno 2018
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 200160
- 2013-000855-42 (Numero EudraCT)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
SÌ
Descrizione del piano IPD
IPD for this study will be made available via the Clinical Study Data Request site.
Periodo di condivisione IPD
IPD is available via the Clinical Study Data Request site (click on the link provided below)
Criteri di accesso alla condivisione IPD
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place.
Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Tipo di informazioni di supporto alla condivisione IPD
- STUDIO_PROTOCOLLO
- LINFA
- ICF
- RSI
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 .
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