- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00374842
Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate
9. Mai 2018 aktualisiert von: GlaxoSmithKline
A Study to Evaluate the Immunogenicity, Safety and Reactogenicity of Adjuvanted Influenza Vaccine Candidates Compared to Fluarix™ Administered Intramuscularly in Subjects Aged 18-59 Years.
The purpose of this study is to evaluate the immunogenicity and the safety of candidate vaccines compared to Fluarix™ administered intramuscularly in subjects aged 18-59 years
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
300
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
-
-
-
Wilrijk, Belgien, 2610
- GSK Investigational Site
-
-
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 59 Jahre (Erwachsene)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
- A male or female aged 18-59 years at the time of the first vaccination.
- Free of obvious health problems
Exclusion Criteria:
- Use of non-registered products
- Administration of immune-modifying drugs.
- Administration of vaccine 30 days before enrolment in study.
- Immunosuppressive or immunodeficient condition.
- Hypersensitivity to a previous dose of influenza vaccine
- Previous vaccination against influenza in 2006
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality.
- History of confirmed influenza infection within the last 12 Months.
- Acute disease at the time of enrolment/vaccination.
- History of allergy or reactions likely to be exacerbated by any component of the 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 |
---|---|
Experimental: GSK1247446A Formulation 1 Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
|
Experimental: GSK1247446A Formulation 2 Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
Low-dose GlaxoSmithKline Biologicals' GSK1247446A influenza vaccine
|
Aktiver Komparator: Fluarix Group
Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
|
GlaxoSmithKline Biologicals' licensed influenza vaccine
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed.
Zeitfenster: At Day 0 and at Day 21.
|
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), B/Malaysia (B/MAL) strains.
Titers were presented as geometric mean titers (GMTs) calculated on subjects with available results, and expressed in haemagglutination-inhibition unit (HIU), e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen.
The seropositivity cut-off value of the assay was 10 HIU.
|
At Day 0 and at Day 21.
|
Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed.
Zeitfenster: At Day 0 and at Day 21.
|
A seroprotected subject was a subject whose antibody titer against each of the influenza strains assessed (A/New Caledonia (A/CAL), A/Wisconsin (A/WIS) and B/Malaysia (B/MAL) strains) was equal to or higher than (>=) the assay seroprotection cut-off value of 40 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen).
|
At Day 0 and at Day 21.
|
Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed
Zeitfenster: At Day 21.
|
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains.
A seroconverted subject was a subject who had either a pre-vaccination serum HI antibody titer lower than 10 haemagglutination-inhibition units (HIU) (e. g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenzae antigen) and a post-vaccination titer higher than or equal to 40 HIU, or a pre-vaccination titer >= 10 and at least a four-fold increase in post- vaccination titer.
|
At Day 21.
|
Seroconversion Factor Against Each of the 3 Influenza Strains Assessed.
Zeitfenster: At Day 21.
|
Influenza strains assessed were the A/New Caledonia (A/CAL), A/Wisconsin (A/WIS), and B/Malaysia (B/MAL) strains.
The seroconversion factor (SCF) was defined as a ratio, as the fold increase in serum haemagglutination-inhibition geometric mean titers (GMTs) post-vaccination compared to Day 0 (with GMTs in the above calculation expressed in haemagglutination-inhibition units (HIU) [e.
g. the dilution of a serum haemagglutination-inhibition containing the specific antibody each of the assessed influenza strains at which the solution retained the minimum level of activity needed to neutralize or precipitate the corresponding influenza antigen]).
|
At Day 21.
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Zeitfenster: Within the 7-day follow-up period (Days 0-6) after vaccination
|
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling the site of injection.
Any = occurrence of a solicited local symptom regardless of intensity grade.
Grade 3 pain = Pain which prevented normal activity.
Grade 3 ecchymosis/redness/swelling = ecchymosis/redness/swelling at injection site with a diameter larger than (>) 50 millimeters (mm).
All solicited local symptoms assessed were considered by the investigator as causally related to the study vaccination.
|
Within the 7-day follow-up period (Days 0-6) after vaccination
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: Within the 7-day follow-up period (Days 0-6) after vaccination
|
Assessed solicited general symptoms were arthralgia, fatigue, fever (axillary temperature higher than or equal to (>=) 37.5 degrees Celsius (°C)), headache, muscle aches, and shivering.
Any = Occurrence of a particular symptom regardless of intensity or relationship to vaccination.
Grade 3 symptom = Symptom which prevented normal activity.
Related = Symptom assessed by the investigator as causally related to the study vaccination.
Grade 3 fever = axillary temperature higher than 39.0°C.
|
Within the 7-day follow-up period (Days 0-6) after vaccination
|
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Zeitfenster: Within the 30-day follow-up period (Days 0-29) after vaccination
|
An unsolicited AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
Any AE = any occurrence of an AE, regardless of intensity or relationship to study vaccination.
Grade 3 = an event that prevented normal activity.
Related = event assessed by the investigator as causally related to the study vaccination.
|
Within the 30-day follow-up period (Days 0-29) after vaccination
|
Number of Subjects With Any and Related Serious Adverse Events (SAEs)
Zeitfenster: From study start to study end, from Day 0 to Day 30
|
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 SAE = any occurrence of an SAE, regardless of relationship to study vaccination.
A related SAE = an SAE assessed by the investigator as causally related to the study vaccination.
|
From study start to study end, from Day 0 to Day 30
|
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. Oktober 2006
Primärer Abschluss (Tatsächlich)
1. November 2006
Studienabschluss (Tatsächlich)
30. November 2006
Studienanmeldedaten
Zuerst eingereicht
8. September 2006
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
8. September 2006
Zuerst gepostet (Schätzen)
12. September 2006
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
8. Juni 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
9. Mai 2018
Zuletzt verifiziert
1. Oktober 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 108656
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
-
Einzelner Teilnehmerdatensatz
Informationskennung: 108656Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
-
Datensatzspezifikation
Informationskennung: 108656Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
-
Studienprotokoll
Informationskennung: 108656Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
-
Einwilligungserklärung
Informationskennung: 108656Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
-
Klinischer Studienbericht
Informationskennung: 108656Informationskommentare: 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 .
Klinische Studien zur GSK1247446A
-
GlaxoSmithKlineAbgeschlossen
-
GlaxoSmithKlineAbgeschlossenGrippeRussische Föderation, Deutschland, Frankreich, Griechenland, Vereinigtes Königreich, Norwegen, Estland
-
GlaxoSmithKlineAbgeschlossen
-
GlaxoSmithKlineAbgeschlossen