Clinical Study for Safety and Immunogenicity Study of Influenza Vaccine
19. august 2014 opdateret af: Crucell Holland BV
A Phase I, Open Label, Randomized Study in Healthy Adults to Compare Safety and Immunogenicity of Different Administration Schedules of Virosomal Influenza Vaccine
The goal of the study is to assess the safety and immune response after vaccination with different doses and vaccination schedules of virosomal influenza vaccine.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Virosomal influenza vaccine is usually administered intramuscularly as a single 0.5 mL dose.
The aim of this study is to evaluate the safety and immunogenicity of different doses and vaccination schedules.
A total of 84 healthy adults aged 18-50 years will be randomized (1:1:1) into 3 treatment groups: subjects of group 1 will receive a standard dose (0.5 mL) at Days 1, 29, and 57; subjects of group 2 will receive a double dose (1.0 mL) at Day 1 and a standard dose (0.5 mL) at Day 57; subjects of group 3 will receive a triple dose (0.5 mL) at Day 1. Local and systemic solicited adverse events up to Day 4 after each vaccination will be documented.
To assess the subjects' humoral and cellular immune response against homologous and heterologous virus strains, blood will be drawn from each participant at baseline (Day 1), at the 4 subsequent monthly visits (Months 1 to 4) and at Month 12.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
84
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Antwerp, Belgien, 2610
- Center for the Evaluation of Vaccination, Unit of Epidemiology and Social Medicine, University of Antwerp
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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 til 50 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Healthy male and female adults
- Aged ≥ 18 to ≤ 50 years on the day of enrollment
- Written informed consent
- Female subjects of childbearing potential using and willing to continue using an acceptable method of contraception unless surgically sterilized/hysterectomized or post-menopausal for more than 2 years
Exclusion Criteria:
- Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
- Body weight below 40 kg at any visit during the study
- Acute febrile illness (≥ 38.0°C)
- Known hypersensitivity to any vaccine component
- Previous history of a serious adverse reaction to influenza vaccine
- Previous vaccination with a seasonal influenza vaccine for season 2011-2012 or a virosomal formulation of seasonal influenza vaccine in any season
- History of egg protein allergy or severe atopy
- Known blood coagulation disorder
- Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, including oral corticosteroids in dosages of ≥ 0.5 mg/kg/d prednisolone or equivalent (inhaled or topical steroids are allowed)
- Known immunodeficiency (incl. leukemia, HIV seropositivity) or cancer
- Known history of psychiatric diseases, particularly dementia
- Investigational medicinal product received in the past 3 months (90 days)
- Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
- Pregnancy or lactation
- Participation in another clinical trial for the entire duration of this trial
- Employee at the investigational site or relative of the investigator
- Subjects who in the view of investigator will not comply with study procedure and/or visit requirements as per protocol
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Group 1
1 x standard dose (0.5 mL) on Day 1, Day 29, and Day 57
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
Andre navne:
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Eksperimentel: Group 2
1 x double standard dose (1.0 mL) on Day 1 and 1 x standard dose (0.5 mL) on Day 57.
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
Andre navne:
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Eksperimentel: Group 3
1 x triple standard dose (1.5 mL) on Day 1
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Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of local and systemic solicited adverse events
Tidsramme: 4 days after each vaccination (day of vaccination and the followoing 3 days)
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4 days after each vaccination (day of vaccination and the followoing 3 days)
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Incidence of unsolicited AEs
Tidsramme: 4 weeks after each vaccination
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4 weeks after each vaccination
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Humoral and cellular immune response against homologous and heterologous vaccine strains
Tidsramme: Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
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Baseline (before vacination) and Months 1, 2, 3, 4, and 12 after vaccination
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Incidence of SAEs
Tidsramme: up to 12 months after baseline
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up to 12 months after baseline
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Enza di Modugno, Crucell Holland
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. juni 2012
Primær færdiggørelse (Faktiske)
1. juni 2013
Studieafslutning (Faktiske)
1. december 2013
Datoer for studieregistrering
Først indsendt
10. maj 2012
Først indsendt, der opfyldte QC-kriterier
8. juni 2012
Først opslået (Skøn)
12. juni 2012
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
20. august 2014
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. august 2014
Sidst verificeret
1. august 2014
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- INF-V-A017
- 2012-001693-28 (EudraCT nummer)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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