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Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Non-Elderly and Elderly Adults

29 ottobre 2015 aggiornato da: Novartis

A Pivotal Randomized, Single-Blind, Dose-Finding Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of an Adjuvanted and Non-Adjuvanted Egg-Derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Adult Subjects 18 or More Years of Age

This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in non-elderly and elderly adults.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Effettivo)

2719

Fase

  • Fase 2
  • 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

  • Messico
      • Tlalpan, Messico, 14000
        • Instituto Nacional de Ciencias
  • Stati Uniti
    • Florida
      • Miami, Florida, Stati Uniti, 33143
        • Miami Research Associates
    • Kansas
      • Lenexa, Kansas, Stati Uniti, 66219
        • Johnson County Clin-Trials
    • Nebraska
      • Omaha, Nebraska, Stati Uniti, 68134
        • Meridien Clinical Research
    • New York
      • Endwell, New York, Stati Uniti, 13760
        • Regional Clinical Research
      • Rochester, New York, Stati Uniti, 14609
        • Rochester Clinical Research, Inc
    • North Carolina
      • Cary, North Carolina, Stati Uniti, 27518
        • Triangle Medical Research Associates
      • Raleigh, North Carolina, Stati Uniti, 27609
        • Triangle Medical Research Associates
      • Winston-Salem, North Carolina, Stati Uniti, 27103
        • Carolina Medical Trials
    • Ohio
      • Franklin, Ohio, Stati Uniti, 45005
        • Prestige Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, Stati Uniti, 73103
        • IPS Research
    • Pennsylvania
      • Erie, Pennsylvania, Stati Uniti, 16506
        • West Ridge Family Practice (adult)
      • Jefferson Hills, Pennsylvania, Stati Uniti, 15025
        • Primary Physicians Research Inc. (adult)
    • Rhode Island
      • Warwick, Rhode Island, Stati Uniti, 02886
        • Omega Clinical Research
    • Texas
      • Dallas, Texas, Stati Uniti, 75234
        • Research Across America
      • Houston, Texas, Stati Uniti, 77055
        • West Houston Clinical Research Service
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84121
        • J. Lewis Research, Inc./Foothill Family Clinic South
      • Salt Lake City, Utah, Stati Uniti, 84109
        • J.Lewis Research, Inc./Foothill Family Clinic
    • Virginia
      • Burke, Virginia, Stati Uniti, 22015
        • Pi-Coor Clinical Research
      • Fairfax, Virginia, Stati Uniti, 22030
        • PI Coor Clinical Research
      • Richmond, Virginia, Stati Uniti, 23219
        • Virginia Commonwealth 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

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Adults 18 years of age and older in good health as determined by medical history, physical assessment and clinical judgement of the investigator and without influenza within the past 6 months.

Exclusion Criteria:

  • History of serious disease.
  • History of serious reaction following administration of vaccine or hypersensitivity to vaccine components.
  • Known or suspected impairment/alteration of immune function.
  • Receipt or planned receipt of seasonal trivalent influenza vaccine within 1 week before or after each study vaccination.
  • Sexually active women of childbearing potential must use acceptable birth control during the treatment phase of the study.
  • For additional entry criteria, please refer to protocol.

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: 3.75_(50)MF59
50% of MF59 with 3.75 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 7.5 w/o MF59
0% of MF59 with 7.5 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 7.5_(50)MF59
50% of MF59 with 7.5 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 7.5_(100)MF59
100% of MF59 with 7.5 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 15 w/o MF59
0% of MF59 with 15 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 15_(50)MF59
50% of MF59 with 15 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 15_(100)MF59
100% of MF59 with 15 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant
Sperimentale: 30 w/o MF59
0% of MF59 with 30 µg A/H1N1 antigen
Biologico: MF59-eH1N1_f
8 arms consisting of different antigen combinations of A/H1N1 S-OIV and different percentages of MF59 adjuvant

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants 18 to 64 Years of Age
Lasso di tempo: 21 days after each vaccination
Seroconversion is defined by CBER (Center for Biologics Evaluation, Research and Review) as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination
Immunogenicity Results After Each Vaccination by Vaccine Group, in Participants ≥65 Years of Age
Lasso di tempo: 21 days after each vaccination
Seroconversion is defined by CBER as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as participants having HI antibody titer ≥1:40.
21 days after each vaccination

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Geometric Mean HI Titer by Vaccine Groups; in Participants 18 to 64 Years of Age and ≥65 Years of Age
Lasso di tempo: 21 days after each vaccination
Geometric mean hemagglutinin inhibition (HI) titer = GMT
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants 18 to 60 Years of Age
Lasso di tempo: 21 days after each vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP (Committee for Medicinal Products for Human Use) criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Number of Subjects With Seroconversion and With HI ≥1:40, in Participants ≥61 Years of Age
Lasso di tempo: 21 days after each vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Seroconversion is defined as the percentage of participants with either a prevaccination HI titer <1:10 and a post vaccination HI titer > 40 or a pre-vaccination HI titer > 10 and a minimum four-fold rise in post-vaccination HI antibody titer. Seroprotection is defined as Hemagglutinin Inhibition (HI) antibody titer ≥1:40.
21 days after each vaccination
Geometric Mean Ratio From Baseline, in Participants 18 to 60 Years of Age and ≥61 Years of Age
Lasso di tempo: 21 days after vaccination
Immunogenicity evaluation after each vaccination by vaccine group according to CHMP criteria. Geometric Mean Ratio (GMR) of the hemagglutinin inhibition (HI)titers.
21 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants 18 to 64 Years of Age
Lasso di tempo: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants 18 to 64 Years of Age
Lasso di tempo: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the First Vaccination, in Participants ≥65 Years of Age
Lasso di tempo: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination
Number of Participants Reporting Solicited Local and Systemic Reactions After the Second Vaccination, in Participants ≥65 Years of Age
Lasso di tempo: 7 days after vaccination
Solicited local and systemic reactions that occurred within 7 days after the day of vaccination were used as indicators of reactogenicity.
7 days after vaccination

Collaboratori e investigatori

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

Sponsor

Novartis

Collaboratori

Novartis Vaccines

Investigatori

  • Direttore dello studio: Novartis Vaccine and Diagnostics, Novartis

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 2009

Completamento primario (Effettivo)

1 novembre 2009

Completamento dello studio (Effettivo)

1 dicembre 2010

Date di iscrizione allo studio

Primo inviato

2 settembre 2009

Primo inviato che soddisfa i criteri di controllo qualità

7 settembre 2009

Primo Inserito (Stima)

9 settembre 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

7 dicembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 ottobre 2015

Ultimo verificato

1 ottobre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • V112_01

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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