Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.
9. Mai 2018 aktualisiert von: GlaxoSmithKline
Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.
The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Studientyp
Interventionell
Einschreibung (Tatsächlich)
420
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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Hradec Kralove, Tschechien, 500 03
- 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:
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
- Written informed consent obtained from the subject.
- If the subject is female, she must be of non-childbearing potential, if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.
Exclusion Criteria:
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
- Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
- Confirmed influenza infection within a year preceding the study start.
- Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
- History of hypersensitivity to a previous dose of influenza vaccine
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Acute disease at the time of enrolment.
- Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
- Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
- Pregnant or lactating female.
- Female planning to become pregnant or planning to discontinue contraceptive precautions.
- History of chronic alcohol consumption and/or drug abuse.
- Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- History of administration of experimental/licensed vaccine.
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: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Experimental: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Aktiver Komparator: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Aktiver Komparator: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
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Single intramuscular dose on Day 0.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Zeitfenster: At Day 0 and Day 21
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Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
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At Day 0 and Day 21
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Zeitfenster: At Day 21
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A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer.
The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Day 21
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HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Zeitfenster: Day 21
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Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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Day 21
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Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Zeitfenster: At Days 0 and 21
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A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection.
The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
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At Days 0 and 21
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Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Zeitfenster: During a 7 day (Days 0-6) follow-up period after vaccination
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Solicited local symptoms assessed were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as considerable pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
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During a 7 day (Days 0-6) follow-up period after vaccination
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Zeitfenster: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling.
Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade.
Grade 3 pain was defined as pain that prevented normal activity.
Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Zeitfenster: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature ≥39.0°C.
Related = symptoms considered by the investigator to have a causal relationship to vaccination
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Zeitfenster: During a 7-day follow-up period (Days 0-6) after vaccination
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Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination.
Any fever = oral temperature ≥ 37.5 °C.
Grade 3 symptoms = symptoms that prevented normal activities.
Grade 3 fever = oral temperature above 39.0°C. .
Related = symptoms considered by the investigator to have a causal relationship to vaccination.
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During a 7-day follow-up period (Days 0-6) after vaccination
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Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Zeitfenster: During the entire study period (Days 0-180)
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MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination.
AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
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During the entire study period (Days 0-180)
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Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Zeitfenster: During a 21 day (Days 0-20) follow-up 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.
Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
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During a 21 day (Days 0-20) follow-up period after vaccination-
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Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Zeitfenster: During the entire study period (Days 0-180)
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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.
Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
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During the entire study period (Days 0-180)
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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.
Allgemeine Veröffentlichungen
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
14. Juli 2008
Primärer Abschluss (Tatsächlich)
28. Januar 2009
Studienabschluss (Tatsächlich)
28. Januar 2009
Studienanmeldedaten
Zuerst eingereicht
11. Juli 2008
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. Juli 2008
Zuerst gepostet (Schätzen)
14. Juli 2008
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2018
Zuletzt verifiziert
1. März 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 111295
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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Einwilligungserklärung
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Kommentiertes Fallberichtsformular
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 111295Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 111295Informationskommentare: 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 .