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Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

9 maggio 2018 aggiornato da: GlaxoSmithKline

Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

720

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

  • Estonia
      • Saku, Estonia, 75501
        • GSK Investigational Site
      • Tallinn, Estonia, 13419
        • GSK Investigational Site
      • Tartu, Estonia, 50417
        • GSK Investigational Site

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 65 years of age or older at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

  • Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, 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 21 days after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Previous vaccination against influenza with any seasonal vaccine since July 2007.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) 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 dose of study vaccine or planned administration during the study period.
  • Any medical conditions in which IM 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: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
Biologico: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
Sperimentale: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
Biologico: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Lasso di tempo: Days 0 and 21
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Lasso di tempo: Days 0 and 21
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Lasso di tempo: Day 21
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 four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
HI Antibody Seroconversion Factors
Lasso di tempo: Day 21
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Lasso di tempo: Days 0 and 21
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Lasso di tempo: During a 7-day period after vaccination
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
During a 7-day period after vaccination
Duration of Solicited Local Symptoms
Lasso di tempo: During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Lasso di tempo: During a 7-day period after vaccination
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day period after vaccination
Duration of Solicited General Symptoms
Lasso di tempo: During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Lasso di tempo: During a 21-day period after vaccination
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.
During a 21-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Lasso di tempo: During a 21-day period after vaccination
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
During a 21-day period after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Lasso di tempo: During the entire study period (up to Day 21)
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.
During the entire study period (up to Day 21)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

GlaxoSmithKline

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.

Collegamenti utili

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

3 marzo 2008

Completamento primario (Effettivo)

11 aprile 2008

Completamento dello studio (Effettivo)

11 aprile 2008

Date di iscrizione allo studio

Primo inviato

29 febbraio 2008

Primo inviato che soddisfa i criteri di controllo qualità

10 marzo 2008

Primo Inserito (Stima)

11 marzo 2008

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

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 111454

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

  1. Piano di analisi statistica
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  2. Set di dati del singolo partecipante
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  3. Modulo di consenso informato
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  4. Specifica del set di dati
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  5. Rapporto di studio clinico
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  6. Protocollo di studio
    Identificatore informazioni: 111454
    Commenti informativi: For additional information about this study please refer to the GSK Clinical Study Register
  7. Modulo di segnalazione del caso annotato
    Identificatore informazioni: 111454
    Commenti 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 .

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