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. Mai 2017 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
400
Phase
- Phase 1
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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Brandenburg
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Finsterwalde, Brandenburg, Deutschland, 03238
- GSK Investigational Site
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Niedersachsen
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Tostedt, Niedersachsen, Deutschland, 21255
- GSK Investigational Site
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Sachsen
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Dresden, Sachsen, Deutschland, 01307
- GSK Investigational Site
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Dresden, Sachsen, Deutschland, 01129
- GSK Investigational Site
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Freiberg, Sachsen, Deutschland, 09599
- GSK Investigational Site
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Geringswalde, Sachsen, Deutschland, 09326
- GSK Investigational Site
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Schmiedeberg, Sachsen, Deutschland, 01762
- GSK Investigational Site
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Schleswig-Holstein
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Bad Segeberg, Schleswig-Holstein, Deutschland, 23795
- GSK Investigational Site
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Elmshorn, Schleswig-Holstein, Deutschland, 25335
- GSK Investigational Site
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
18 Jahre bis 60 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: 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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Experimental: 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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Experimental: 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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Experimental: 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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Aktiver 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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Aktiver 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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Aktiver 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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Aktiver 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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To evaluate the humoral immune response induced by the study vaccines in term of anti-haemagglutinin antibody titers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: During the entire study (Days 0 to 180)
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During the entire study (Days 0 to 180)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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To evaluate the humoral immune response induced by the study vaccines in term of serum neutralizing antibody titers
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At Days 21, 42 and 180
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At Days 21, 42 and 180
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Tatsächlich)
29. März 2006
Primärer Abschluss (Tatsächlich)
1. November 2006
Studienabschluss (Tatsächlich)
16. November 2006
Studienanmeldedaten
Zuerst eingereicht
31. März 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
31. März 2006
Zuerst gepostet (Schätzen)
3. April 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Mai 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
5. Mai 2017
Zuletzt verifiziert
1. Mai 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 106378
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