A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
26. srpna 2011 aktualizováno: 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.
Přehled studie
Postavení
Dokončeno
Podmínky
Detailní popis
Participants will receive a single injection of their randomized vaccine on Day 0.
Typ studie
Intervenční
Zápis (Aktuální)
548
Fáze
- Fáze 2
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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California
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Anaheim, California, Spojené státy, 92801
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Fountain Valley, California, Spojené státy, 92708
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Florida
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South Miami, Florida, Spojené státy, 33143
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Missouri
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Springfield, Missouri, Spojené státy, 65802
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New York
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Rochester, New York, Spojené státy, 14609
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North Carolina
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Raleigh, North Carolina, Spojené státy, 27612
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Ohio
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Cincinnati, Ohio, Spojené státy, 45227
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Cleveland, Ohio, Spojené státy, 44122
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Pennsylvania
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Grove City, Pennsylvania, Spojené státy, 16127
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Jefferson Hills, Pennsylvania, Spojené státy, 15025
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Rhode Island
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Warwick, Rhode Island, Spojené státy, 02886
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Tennessee
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Jackson, Tennessee, Spojené státy, 38305
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Utah
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Salt Lake City, Utah, Spojené státy, 84109
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Salt Lake City, Utah, Spojené státy, 84124
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Springville, Utah, Spojené státy, 84663
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let a starší (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ano
Pohlaví způsobilá ke studiu
Všechno
Popis
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.
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
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0.5 mL, Intramuscular on Day 0
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Experimentální: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
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0.5 mL, Intramuscular on Day 0
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Aktivní komparátor: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
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0.5 mL, Intramuscular on Day 0
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Aktivní komparátor: A/H1N1 Vaccine Group 4
Participants will receive A/H1N1 vaccine formulation 4
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0.5 mL, Intramuscular on Day 0
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Komparátor placeba: Placebo Group 5
Participants will receive a placebo vaccine
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0.5 mL, Intramuscular on Day 0
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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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
Časové okno: 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.
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Day 0 and Day 21 post-vaccination
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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
Časové okno: 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).
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Day 0 and Day 21 post-vaccination
|
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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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
Časové okno: Day 0 up to Day 7 post-vaccination
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Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis.
Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
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Day 0 up to Day 7 post-vaccination
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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
Časové okno: Day 0 up to Day 7 post-vaccination
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Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis.
Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
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Day 0 up to Day 7 post-vaccination
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Užitečné odkazy
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia
1. října 2009
Primární dokončení (Aktuální)
1. prosince 2010
Dokončení studie (Aktuální)
1. března 2011
Termíny zápisu do studia
První předloženo
3. srpna 2009
První předloženo, které splnilo kritéria kontroly kvality
3. srpna 2009
První zveřejněno (Odhad)
6. srpna 2009
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
3. října 2011
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
26. srpna 2011
Naposledy ověřeno
1. srpna 2011
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- FUF16
- UTN: U1111-1111-4882
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .