Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations
9. Mai 2018 aktualisiert von: GlaxoSmithKline
Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.
The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
720
Phase
- Phase 2
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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Saku, Estland, 75501
- GSK Investigational Site
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Tallinn, Estland, 13419
- GSK Investigational Site
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Tartu, Estland, 50417
- 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
65 Jahre und älter (Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female 65 years of age or older at the time of vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.
Exclusion Criteria:
- Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
- Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
- Previous vaccination against influenza with any seasonal vaccine since July 2007.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of hypersensitivity to a previous dose of influenza vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing 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 dose of study vaccine or planned administration during the study period.
- Any medical conditions in which IM injections are contraindicated
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: Vervierfachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Experimental: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
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Intramuscular administration, 1 dose
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Zeitfenster: Days 0 and 21
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Titers were expressed as Geometric Mean Titers (GMTs).
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Zeitfenster: Days 0 and 21
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A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Days 0 and 21
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Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Zeitfenster: Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer.
The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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HI Antibody Seroconversion Factors
Zeitfenster: Day 21
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Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Zeitfenster: Days 0 and 21
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A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
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Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Zeitfenster: During a 7-day period after vaccination
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Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
Any: any symptom regardless of intensity grade.
Grade 3 pain: considerable pain at rest, which prevented normal everyday activities.
Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
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During a 7-day period after vaccination
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Duration of Solicited Local Symptoms
Zeitfenster: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: During a 7-day period after vaccination
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Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C).
Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C.
Related: symptom assessed by the investigator as causally related to the study vaccination.
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During a 7-day period after vaccination
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Duration of Solicited General Symptoms
Zeitfenster: During a 7-day period after vaccination
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Duration was expressed as median number of days the symptom persisted.
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
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During a 7-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Zeitfenster: During a 21-day period after vaccination
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Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Zeitfenster: During a 21-day period after vaccination
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Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
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During a 21-day period after vaccination
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Zeitfenster: During the entire study period (up to Day 21)
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SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
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During the entire study period (up to Day 21)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
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
3. März 2008
Primärer Abschluss (Tatsächlich)
11. April 2008
Studienabschluss (Tatsächlich)
11. April 2008
Studienanmeldedaten
Zuerst eingereicht
29. Februar 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
10. März 2008
Zuerst gepostet (Schätzen)
11. März 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2018
Zuletzt verifiziert
1. November 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 111454
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Studiendaten/Dokumente
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Statistischer Analyseplan
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einwilligungserklärung
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Kommentiertes Fallberichtsformular
Informationskennung: 111454Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .