A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
6 febbraio 2014 aggiornato da: Sanofi Pasteur, a Sanofi Company
Immunogenicity and Safety of Multiple Formulations of an 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.
Primary Objectives:
- To describe the immunogenicity of the candidate vaccines after each injection.
- To describe the safety of the candidate vaccines after each injection.
Panoramica dello studio
Stato
Completato
Condizioni
Descrizione dettagliata
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Tipo di studio
Interventistico
Iscrizione (Effettivo)
849
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
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Alabama
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Hoover, Alabama, Stati Uniti, 35216
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Arizona
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Chandler, Arizona, Stati Uniti, 85224
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Phoenix, Arizona, Stati Uniti, 85020
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California
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Anaheim, California, Stati Uniti
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Florida
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South Miami, Florida, Stati Uniti, 33143
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Kentucky
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Maddisonville, Kentucky, Stati Uniti, 42431
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Missouri
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Springfield, Missouri, Stati Uniti, 65802
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North Carolina
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Raleigh, North Carolina, Stati Uniti, 27612
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Ohio
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Cincinnati, Ohio, Stati Uniti, 45227
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Cleveland, Ohio, Stati Uniti, 44122
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South Carolina
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Mt. Pleasant, South Carolina, Stati Uniti, 29464
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Tennessee
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Knoxville, Tennessee, Stati Uniti, 37920
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Texas
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Austin, Texas, Stati Uniti, 78705
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Utah
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Salt Lake City, Utah, Stati Uniti, 84124
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Virginia
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Norfolk, Virginia, Stati Uniti, 23507
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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
- 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 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
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 |
|---|---|
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Sperimentale: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1
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0.5 mL, Intramuscular on Day 0 and on Day 21
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Sperimentale: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2
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0.5 mL, Intramuscular on Day 0 and Day 21
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Comparatore placebo: Placebo Group
Participants will receive a placebo vaccine
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0.5 mL, Intramuscular on Day 0 and Day 21
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Sperimentale: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 Vaccine formulation 3
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0.5 mL, Intramuscular on Day 0 and day 21
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Lasso di tempo: Pre-vaccination (Day 0) and day 21 post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
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Pre-vaccination (Day 0) and day 21 post-vaccination
|
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Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Lasso di tempo: Pre-vaccination (Day 0) and Day 21 post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and Day 21 post-vaccination
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Lasso di tempo: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1) Strain - Age ≥ 65 Years
Lasso di tempo: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Lasso di tempo: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Seroprotection: Antibody titer ≥ 40 1/dil.
Antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age ≥ 65 Years
Lasso di tempo: Pre-vaccination (Day 0) and 21 days post-vaccination
|
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
|
Pre-vaccination (Day 0) and 21 days post-vaccination
|
|
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Lasso di tempo: Days 0 to 7 post-vaccination
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Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
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Days 0 to 7 post-vaccination
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age ≥ 65 Years
Lasso di tempo: Days 0 to 7 post-vaccination
|
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising).
Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering (chills).
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Days 0 to 7 post-vaccination
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
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 agosto 2009
Completamento primario (Effettivo)
1 marzo 2010
Completamento dello studio (Effettivo)
1 dicembre 2010
Date di iscrizione allo studio
Primo inviato
3 agosto 2009
Primo inviato che soddisfa i criteri di controllo qualità
4 agosto 2009
Primo Inserito (Stima)
6 agosto 2009
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
10 marzo 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
6 febbraio 2014
Ultimo verificato
1 febbraio 2014
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- FUF14
- UTN: U1111-1111-4798 (Altro identificatore: WHO)
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 .