- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00953524
A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly
6. februar 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.
Studietype
Intervensjonell
Registrering (Faktiske)
849
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Alabama
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Hoover, Alabama, Forente stater, 35216
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Arizona
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Chandler, Arizona, Forente stater, 85224
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Phoenix, Arizona, Forente stater, 85020
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California
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Anaheim, California, Forente stater
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Florida
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South Miami, Florida, Forente stater, 33143
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Kentucky
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Maddisonville, Kentucky, Forente stater, 42431
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Missouri
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Springfield, Missouri, Forente stater, 65802
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North Carolina
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Raleigh, North Carolina, Forente stater, 27612
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Ohio
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Cincinnati, Ohio, Forente stater, 45227
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Cleveland, Ohio, Forente stater, 44122
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South Carolina
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Mt. Pleasant, South Carolina, Forente stater, 29464
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Tennessee
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Knoxville, Tennessee, Forente stater, 37920
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Texas
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Austin, Texas, Forente stater, 78705
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Utah
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Salt Lake City, Utah, Forente stater, 84124
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Virginia
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Norfolk, Virginia, Forente stater, 23507
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Placebo komparator: 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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Eksperimentell: 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 18 to 64 Years
Tidsramme: 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
Tidsramme: 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.
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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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
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Number of Participants With At Least One Solicited Injection Site or Systemic Reaction - Age 18 to 64 Years
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. august 2009
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. desember 2010
Datoer for studieregistrering
Først innsendt
3. august 2009
Først innsendt som oppfylte QC-kriteriene
4. august 2009
Først lagt ut (Anslag)
6. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
10. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- FUF14
- UTN: U1111-1111-4798 (Annen identifikator: WHO)
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