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Safety and Immunogenicity of 3 Lots of Cell-derived Subunit Influenza Vaccine as Compared to 1 Lot to Egg-derived Subunit Influenza Vaccine in Healthy Adults (>=18 to <=60)

2 agosto 2019 aggiornato da: Novartis Vaccines

A Phase III, Randomized, Controlled, Observer-Blind, Multi-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Single Intramuscular Dose of Three Lots of a Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Or of a Trivalent Subunit Influenza Vaccine Produced in Embryonated Hen Eggs, in Healthy Adult Subjects Aged >=18 to <=60

The present study aims to evaluate safety, tolerability and immunogenicity of three lots of Chiron's cell-derived subunit influenza vaccine in healthy adult subjects as compared to a conventional egg-derived control vaccine licensed in Europe.

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1200

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

      • Panevezys, Lituania
        • 2nd Department of Internal Diseases, Panevezys Hospital,
      • Vilnius, Lituania
        • Dept. Infectious Diseases and Microbiology of Vilnius University

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

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  1. 18 to <61 years of age
  2. mentally competent to understand the nature, the scope and the consequences of the study
  3. able and willing to give written informed consent prior to study entry
  4. in good health as determined by:

    1. medical history,
    2. physical examination,
    3. clinical judgment of the Investigator.

Exclusion Criteria:

  1. unwilling or unable to give written informed consent to participate in the study
  2. participation in another clinical trial of an investigational agent within 90 days prior to Visit 1 and throughout the entire study
  3. currently experiencing an acute infectious disease
  4. any serious disease, such as, for example:

    1. cancer,
    2. autoimmune disease (including rheumatoid arthritis),
    3. advanced arteriosclerotic disease or complicated diabetes mellitus,
    4. chronic obstructive pulmonary disease (COPD) requiring oxygen therapy,
    5. acute or progressive hepatic disease,
    6. acute or progressive renal disease,
    7. congestive heart failure
  5. surgery planned during the study period
  6. bleeding diathesis
  7. history of hypersensitivity to any component of the study medication or chemically related substances
  8. history of any anaphylaxis, serious vaccine reactions, or allergy to any of the vaccine component
  9. known or suspected impairment/alteration of immune function, for example resulting from:

    1. receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
    2. receipt of immunostimulants,
    3. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivates within 3 months prior to Visit 1 or planned during the full length of the study,
    4. high risk for developing an immunocompromising disease
  10. history of drug or alcohol abuse
  11. laboratory-confirmed influenza disease within 6 months prior to Visit 1
  12. receipt of influenza vaccine within 6 months prior to Visit 1
  13. receipt of another vaccine within 60 days prior to Visit 1, or planned vaccination within 3 weeks following study vaccination
  14. any acute respiratory disease or infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) or experienced fever (i.e., axillary temperature ≥ 38 degree C) within 5 days prior to Visit 1
  15. if female, pregnant or breastfeeding
  16. if female, refusal to use a reliable contraceptive method during the three weeks following vaccination
  17. planned relocation abroad during the study period
  18. any condition that, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.

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: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: cTIV_lot 1
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1
Sperimentale: cTIV_lot 2
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
Sperimentale: cTIV_lot 3
One single 0.5ml intramuscular injection of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3
Comparatore attivo: TIV group
One single 0.5ml intramuscular injection of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Geometric Mean Titers After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Lasso di tempo: Day 22 postvaccination

The haemagglutinin Inhibition (HI) antibody titer response following

  1. one dose of cTIV for each of the three lots separately and
  2. one dose of cTIV (combined) compared to TIV is reported as Geometric mean titers (GMTs).

The HI GMTs were evaluated using egg-derived antigen assay.

Day 22 postvaccination
Geometric Mean Ratios After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine in Adult Subjects
Lasso di tempo: Day 22 postvaccination

Immunogenicity was assessed in terms of Geometric Mean Ratio (GMR) following

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

The European licensure (CHMP) criterion is met if the mean geometric increase (GMR, day 22/day 1) in HI antibody titer is >2.5.

Day 22 postvaccination
Percentage of Subjects With HI Titers ≥40
Lasso di tempo: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects achieving HI titers ≥40, after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is >70%.

Day 22 postvaccination
Percentage of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After One Dose of Either Cell-derived or Egg-derived Subunit Trivalent Influenza Vaccine
Lasso di tempo: Day 22 postvaccination

Immunogenicity was assessed in terms of percentage of adult subjects showing seroconversion or significant increase in HI antibody titers after

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. one dose of cTIV (combined) compared to TIV, according to the CHMP criterion.

European Licensure (CHMP) criterion is met if the percentage of subjects achieving seroconversion or significant increase is >40%.

As per European Licensure (CHMP) criterion seroconversion is defined as percentage of subjects with a prevaccination HI titer <10 to a postvaccination titer ≥40; whereas, significant increase is defined as HI titer ≥10 prevaccination and ≥4-fold Hi titer increase post-vaccination.

Day 22 postvaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Subjects Reporting Solicited Adverse Events After One Dose of Cell Culture-derived or the Egg-derived Influenza Vaccine.
Lasso di tempo: Day 1 to Day 7 postvaccination

To assess the safety and tolerability in terms of number of subjects reporting solicited adverse events following one injection of

  1. one dose of cTIV for each of the three vaccine lots separately and
  2. for one dose of cTIV (combined) compared to TIV.
Day 1 to Day 7 postvaccination
Safety Data of Subjects Upto Six Months After One Dose of Cell Culture Derived or Egg-derived Influenza Vaccine
Lasso di tempo: Day 1 - Day 181 postvaccination
Additional safety data from day 1 through day 181 after one dose of cTIV (combined) or TIV in terms of serious adverse events (SAEs), adverse events (AEs) necessitating a physician's visit and/or resulting in premature subject's withdrawal from study is reported.
Day 1 - Day 181 postvaccination

Collaboratori e investigatori

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

Investigatori

  • Cattedra di studio: Novartis Vaccines, Novartis Vaccines & Diagnostics

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 settembre 2005

Completamento primario (Effettivo)

1 ottobre 2005

Completamento dello studio (Effettivo)

1 aprile 2006

Date di iscrizione allo studio

Primo inviato

3 aprile 2006

Primo inviato che soddisfa i criteri di controllo qualità

3 aprile 2006

Primo Inserito (Stima)

5 aprile 2006

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 agosto 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 agosto 2019

Ultimo verificato

1 agosto 2019

Maggiori informazioni

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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