- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00968890
Immunogenicity and Safety of Vaccine GSK2340272A (H1N1) and GSK Biologicals Fluarix™ Vaccine When Co-administered in Elderly
Immunogenicity, Safety and Reactogenicity of GSK Biologicals' Influenza GSK2340272A and Fluarix™ 2009-2010 Vaccines When Co-administered in Elderly Subjects Aged 61 Years and Older
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
The study will be conducted in an open manner regarding the administration of vaccine GSK2340272A.
The study will be observer-blind regarding the administration of Fluarix™ and placebo vaccines.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Eskilstuna, Svezia, SE-631 88
- GSK Investigational Site
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Örebro, Svezia, SE-703 62
- GSK Investigational Site
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Male or female subjects 61 years of age or older at the time of the first vaccination
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject.
- Satisfactory baseline medical assessment by history and physical examination.
- Access to a consistent means of telephone contact.
Exclusion Criteria:
- Previous administration of the 2009 Southern Hemisphere or 2009-2010 Northern Hemisphere seasonal influenza vaccine.
- Previous administration of a pandemic influenza vaccine.
- Administration of any vaccine within 30 days before first vaccination.
- Planned administration of a vaccine not foreseen by the study protocol one month (minimum 30 days) after the second vaccination with vaccine GSK2340272A.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccines or planned use during the study period. Potential subjects in the follow-up (i.e., no treatment) phase of a prior investigational study may be enrolled if the investigator's judgment is that it will have no effect on safety, reactogenicity, or immunogenicity endpoints in this study, and that it does not violate the protocol requirements of the prior trial.
- Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
- Presence of an oral temperature >= 37.5°C, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
- Diagnosed with cancer, or treatment for cancer, within 3 years.
- Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
- Chronic administration of immunosuppressants or other immune modifying drugs within six months prior to the first vaccination.
- Receipt of any immunoglobulins and/or any blood products within 3 months preceding the first vaccination or planned administration of any of these products during the entire study period.
- Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic anti-platelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
- An acute evolving neurological disorder or history of Guillain-Barré syndrome.
- Serious chronic disease as determined by medical history and physical examination.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormalities, as determined by physical examination or laboratory screening tests.
- Any known or suspected allergy to any constituent of influenza vaccines.
- History of chronic alcohol consumption and/or drug abuse.
- Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
- Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
Piano di studio
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: Pandemrix+Fluarix and Pandemrix+Placebo
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
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Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
Altri nomi:
Intramuscular injection, 1 dose
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Sperimentale: Pandemrix+Placebo and Pandemrix+Fluarix
Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
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Intramuscular injection, 2 doses
Intramuscular injection, 1 dose
Altri nomi:
Intramuscular injection, 1 dose
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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 Seroconverted Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Lasso di tempo: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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Number of Seroprotected Subjects After the Second Dose of Pandemrix and After Vaccination With Fluarix
Lasso di tempo: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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A seroprotected subject was a subject with reciprocal HI titers >= 40 against the vaccine homologous virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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Geometric Mean Fold Rise (GMFR) After the Second Dose of Pandemrix and After Vaccination With Fluarix
Lasso di tempo: 21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
21 days after the second dose of Pandemrix (=Day 42) and after vaccination with Fluarix (=Day 21 for Pandemrix+Fluarix and Pandemrix+Placebo Group or Day 42 for Pandemrix+ Placebo and Pandemrix+Fluarix Group)
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Geometric Mean Titers for Antibodies Against Pandemrix and Fluarix Vaccine Strains
Lasso di tempo: Days 0, 21, 42, 182, 364
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Titers are expressed as GMTs. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
Days 0, 21, 42, 182, 364
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Number of Seroconverted Subjects
Lasso di tempo: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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A seroconverted subject is a subject who had either a pre-vaccination reciprocal hemagglutination inhibition (HI) titer < 10 and a postvaccination reciprocal titer >= 40, or a pre-vaccination reciprocal HI titer >= 10 and at least a 4-fold increase in post vaccination reciprocal titer against the vaccine virus. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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Number of Seroprotected Subjects
Lasso di tempo: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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A seroprotected subject is a subject with reciprocal HI titers >= 40 against the vaccine homologous virus.
The Pandemrix vaccine strain was A/Cal/09.
The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
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at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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Geometric Mean Fold Rise (GMFR)
Lasso di tempo: at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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The GMFR is defined as the Geometric Mean of the within-subject ratios of the post-vaccination reciprocal HI titer to the pre-vaccination reciprocal HI titer for the vaccine virus.
The Pandemrix vaccine strain was A/Cal/09.
The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08.
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at Day 21 (for Pandemrix vaccine strain only), Day 182 and Day 364
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Number of Subjects With Titers Equal to or Above Titer 1:10
Lasso di tempo: Days 0, 21, 42, 182, 364
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The cut-off 1:10 was considered as seropositivity. The Pandemrix vaccine strain was A/Cal/09. The Fluarix vaccine strains were A/Bri/07, A/Uru/07 and B/Bri/08. |
Days 0, 21, 42, 182, 364
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Number of Subjects With Solicited Local and General Symptoms
Lasso di tempo: Within 7 days (Day 0-Day 6) after each vaccination
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Solicited local symptoms are pain, redness and swelling at the injection site.
They are divided between solicited local symptoms occurring after administration of Pandemrix, Fluarix or Placebo.
Solicited general symptoms are fatigue, headache, joint pain at other location, muscle aches, shivering, sweating and temperature (defined as axillary temperature >= 38.0 degrees Celsius).
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Within 7 days (Day 0-Day 6) after each vaccination
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Number of Subjects With Unsolicited Adverse Events (AEs)
Lasso di tempo: From Day 0 to Day 83
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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
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From Day 0 to Day 83
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Number of Subjects With Adverse Events of Specific Interest
Lasso di tempo: From Day 0 to Day 364
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Adverse events of specific interest include autoimmune diseases and other immune mediated inflammatory disorders.
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From Day 0 to Day 364
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Number of Subjects With Serious Adverse Events (SAEs)
Lasso di tempo: From Day 0 to Day 364
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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.
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From Day 0 to Day 364
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Collaboratori e investigatori
Sponsor
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 113525
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Dati/documenti di studio
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Modulo di segnalazione del caso annotato
Identificatore informazioni: 113525Commenti 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: 113525Commenti 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: 113525Commenti 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: 113525Commenti 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: 113525Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
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Protocollo di studio
Identificatore informazioni: 113525Commenti 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: 113525Commenti 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 .