- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00309647
Study to Evaluate the Safety and Immunogenicity of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) in Adults 18 and 60 Years of Age
5 maj 2017 uppdaterad av: GlaxoSmithKline
A Partially-blind Multi-centric Study in Adults Aged Between 18-60 Years Designed to Evaluate the Reactogenicity and Immunogenicity of 1 and 2 Doses of Pandemic Monovalent (H5N1) Influenza Vaccines (Whole Virus Formulation) Administered at Different Doses and Adjuvanted or Not
Today, the leading contender for the next pandemic of influenza is H5N1, a strain of avian virus.
Prevention and control of a pandemic will depend on the rapid production and worldwide distribution of specific pandemic vaccines.
Candidate 'pandemic-like' vaccines must be developed and tested in clinical trials to determine the most optimal formulation and the best vaccination schedule.This study is designed to test in healthy adults aged between 18-60 years the reactogenicity and immunogenicity of one and two administrations of a candidate pandemic H5N1 vaccine formulated from Whole Virus.
The vaccines contain different antigen doses.
For each dose, adjuvanted vaccine will be compared to the plain vaccine in order to detect the optimal formulation for immunization against the H5N1 influenza strain.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Interventionell
Inskrivning (Faktisk)
400
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Brandenburg
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Finsterwalde, Brandenburg, Tyskland, 03238
- GSK Investigational Site
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Niedersachsen
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Tostedt, Niedersachsen, Tyskland, 21255
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Tyskland, 01307
- GSK Investigational Site
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Dresden, Sachsen, Tyskland, 01129
- GSK Investigational Site
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Freiberg, Sachsen, Tyskland, 09599
- GSK Investigational Site
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Geringswalde, Sachsen, Tyskland, 09326
- GSK Investigational Site
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Schmiedeberg, Sachsen, Tyskland, 01762
- GSK Investigational Site
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Schleswig-Holstein
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Bad Segeberg, Schleswig-Holstein, Tyskland, 23795
- GSK Investigational Site
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Elmshorn, Schleswig-Holstein, Tyskland, 25335
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 60 år (Vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion criteria:
- A male or female between, and including, 18 and 60 years of age at the time of the first vaccination.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- If the subject is female, she must be of non-childbearing potential.
Exclusion criteria:
- Administration of any vaccine during the period starting 15 days before the first administration of the study vaccine and ending 21 after the second one.
- Administration of an influenza vaccine other than the study vaccines during the entire study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the first administration of the study vaccine or during the study.
- lactating women
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: H5N1 Formulation 1 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 1 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Experimentell: H5N1 Formulation 2 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 2 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Experimentell: H5N1 Formulation 3 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 3 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Experimentell: H5N1 Formulation 4 Group
Subjects in this group received 2 doses of H5N1 adjuvanted formulation 4 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Aktiv komparator: H5N1 Formulation 5 Group
Subjects in this group received 2 doses of H5N1 formulation 5 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Aktiv komparator: H5N1 Formulation 6 Group
Subjects in this group received 2 doses of H5N1 formulation 6 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Aktiv komparator: H5N1 Formulation 7 Group
Subjects in this group received 2 doses of H5N1 formulation 7 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Aktiv komparator: H5N1 Formulation 8 Group
Subjects in this group received 2 doses of H5N1 formulation 8 vaccine at a 21-day interval
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2 doses administered intramuscularly at the deltoid region of the non-dominant arm at Days 0 and 21
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Tidsram: At Days 0, 21, 42 and 180
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Geometric mean titers (GMTs) of serum antibodies
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At Days 0, 21, 42 and 180
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To evaluate the humoral immune response induced by the study vaccines in terms of seroconversion rates (SCRs), Conversion factors and protection rates to H5N1 virus
Tidsram: At days 21, 42 and 180
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At days 21, 42 and 180
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Occurrence of solicited local and general adverse events
Tidsram: During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
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During a 7 day follow-up period (i.e. day of vaccination and 6 subsequent days) after each dose of vaccine and overall
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Occurrence of unsolicited adverse events
Tidsram: During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
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During a 21 day follow-up period after the first vaccination and 30 day follow-up period after the second vaccination
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Occurrence of serious adverse events
Tidsram: During the entire study (Days 0 to 180)
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During the entire study (Days 0 to 180)
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Tidsram: At Days 0, 21, 42 and 180
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Geometric mean titers (GMTs) of serum antibodies
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At Days 0, 21, 42 and 180
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To evaluate the cell-mediated immune response induced by the study vaccines in term of frequency of influenza-specific CD4/CD8 T lymphocytes
Tidsram: At days 0, 21, 42 and 180
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At days 0, 21, 42 and 180
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To evaluate the humoral immune response induced by the study vaccines in terms of SCR for serum neutralizing antibody titers
Tidsram: At Days 21, 42 and 180
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At Days 21, 42 and 180
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
29 mars 2006
Primärt slutförande (Faktisk)
1 november 2006
Avslutad studie (Faktisk)
16 november 2006
Studieregistreringsdatum
Först inskickad
31 mars 2006
Först inskickad som uppfyllde QC-kriterierna
31 mars 2006
Första postat (Uppskatta)
3 april 2006
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 maj 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
5 maj 2017
Senast verifierad
1 maj 2017
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 106378
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
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