Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

26 agosto 2011 aggiornato da: Sanofi

Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly.

Primary Objectives:

  • To describe the immunogenicity of the candidate vaccines after a single injection.
  • To describe the safety of the candidate vaccines after a single injection.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Participants will receive a single injection of their randomized vaccine on Day 0.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

548

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

  • Stati Uniti
    • California
      • Anaheim, California, Stati Uniti, 92801
      • Fountain Valley, California, Stati Uniti, 92708
    • Florida
      • South Miami, Florida, Stati Uniti, 33143
    • Missouri
      • Springfield, Missouri, Stati Uniti, 65802
    • New York
      • Rochester, New York, Stati Uniti, 14609
    • North Carolina
      • Raleigh, North Carolina, Stati Uniti, 27612
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45227
      • Cleveland, Ohio, Stati Uniti, 44122
    • Pennsylvania
      • Grove City, Pennsylvania, Stati Uniti, 16127
      • Jefferson Hills, Pennsylvania, Stati Uniti, 15025
    • Rhode Island
      • Warwick, Rhode Island, Stati Uniti, 02886
    • Tennessee
      • Jackson, Tennessee, Stati Uniti, 38305
    • Utah
      • Salt Lake City, Utah, Stati Uniti, 84109
      • Salt Lake City, Utah, Stati Uniti, 84124
      • Springville, Utah, Stati Uniti, 84663

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 :

  • Healthy adults aged 18 years or older on the day of inclusion
  • Informed consent has been signed and dated
  • Able to attend all scheduled visits and comply with all trial procedures
  • For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Exclusion Criteria :

  • Known pregnancy or positive urine pregnancy test
  • Currently breastfeeding a child
  • Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
  • Planned participation in another clinical trial during the present trial period
  • Receipt of any vaccine in the 4 weeks preceding the trial vaccination, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination
  • Planned receipt of any vaccine prior to the Day 42 blood sample
  • Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
  • Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
  • Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B antigen, or Hepatitis C
  • Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
  • Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
  • Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
  • Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
  • Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
  • Chronic illness that in the opinion of the Investigator, is at a stage where it might interfere with trial conduct or completion
  • Employees of the Investigator or study center, with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as family members of the employees or the Investigator
  • Previous participation in a swine-origin A/H1N1 pandemic flu trial except if performed in 1976
  • Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
  • Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C ]) or moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination
  • Personal or family history of Guillain-Barré syndrome
  • Active neoplastic disease or a history of any hematologic malignancy
  • Known seizure/epilepsy history and/or taking anti-seizure medication
  • Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
  • Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
  • Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening
  • Receipt of any monovalent 2009 pandemic H1N1 vaccine.

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: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
Biologico: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Sperimentale: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
Biologico: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Comparatore attivo: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
Biologico: Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Comparatore attivo: A/H1N1 Vaccine Group 4
Participants will receive A/H1N1 vaccine formulation 4
Biologico: Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Comparatore placebo: Placebo Group 5
Participants will receive a placebo vaccine
Biologico: Normal saline solution
0.5 mL, Intramuscular on Day 0

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Day 0 and Day 21 post-vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Day 0 and Day 21 post-vaccination
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Day 0 and Day 21 post-vaccination
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Day 0 and Day 21 post-vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Day 0 and Day 21 post-vaccination
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Lasso di tempo: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Day 0 and Day 21 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Lasso di tempo: Day 0 up to Day 7 post-vaccination
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Day 0 up to Day 7 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Lasso di tempo: Day 0 up to Day 7 post-vaccination
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Day 0 up to Day 7 post-vaccination

Collaboratori e investigatori

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

Sponsor

Sanofi

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

1 ottobre 2009

Completamento primario (Effettivo)

1 dicembre 2010

Completamento dello studio (Effettivo)

1 marzo 2011

Date di iscrizione allo studio

Primo inviato

3 agosto 2009

Primo inviato che soddisfa i criteri di controllo qualità

3 agosto 2009

Primo Inserito (Stima)

6 agosto 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

3 ottobre 2011

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 agosto 2011

Ultimo verificato

1 agosto 2011

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • FUF16
  • UTN: U1111-1111-4882

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 .

Sottoscrivi