Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

26. august 2011 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

548

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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, 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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: A/H1N1 Vaccine Group 1
Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
Biologisk: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Eksperimentel: A/H1N1 Vaccine Group 2
Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
Biologisk: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
0.5 mL, Intramuscular on Day 0
Aktiv komparator: A/H1N1 Vaccine Group 3
Participants will receive A/H1N1 vaccine formulation 3
Biologisk: Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Aktiv komparator: A/H1N1 Vaccine Group 4
Participants will receive A/H1N1 vaccine formulation 4
Biologisk: Monovalent Subvirion A/H1N1 influenza vaccine
0.5 mL, Intramuscular on Day 0
Placebo komparator: Placebo Group 5
Participants will receive a placebo vaccine
Biologisk: Normal saline solution
0.5 mL, Intramuscular on Day 0

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sanofi

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2009

Primær færdiggørelse (Faktiske)

1. december 2010

Studieafslutning (Faktiske)

1. marts 2011

Datoer for studieregistrering

Først indsendt

3. august 2009

Først indsendt, der opfyldte QC-kriterier

3. august 2009

Først opslået (Skøn)

6. august 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

3. oktober 2011

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. august 2011

Sidst verificeret

1. august 2011

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FUF16
  • UTN: U1111-1111-4882

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Abonner