- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00985790
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine in Healthy Children
22. August 2018 aktualisiert von: GlaxoSmithKline
Immunogenicity and Safety Study of a GlaxoSmithKline Biologicals' Candidate Influenza Vaccine GSK2321138A in Healthy Children
The purpose of the present study is to assess the immunogenicity and safety of vaccine GSK2321138A in children.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
599
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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Mexico city, Mexiko, 04530
- GSK Investigational Site
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Estado De México
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Ecatepec de Morelos, Estado De México, Mexiko, 55075
- 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
1 Jahr bis 3 Jahre (Kind)
Akzeptiert gesunde Freiwillige
Ja
Studienberechtigte Geschlechter
Alle
Beschreibung
Inclusion Criteria:
For all subjects:
- Subjects who the investigator believes that they and/or their Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
- Written informed consent obtained from the subject/from the LAR(s).
For unprimed subjects:
- A male or female child aged 18 to 47 months at the time of the first vaccination.
- Children who did not have influenza vaccine in a previous season.
For primed subjects from study NCT00764790:
• Children who received Fluarix™ in the 111751 study NCT00764790.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- History of hypersensitivity to any vaccine.
- History of allergy or reactions likely to be exacerbated by any component of the vaccine.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before and ending 28 days after each dose of vaccine(s).
- Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Acute disease at the time of enrolment.
- History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine.
- Receipt of another seasonal influenza vaccine outside of this study, during current (2009-2010) flu season.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccination Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or blood products within the 3 month preceding the first dose of study vaccine or planned administration during the study period.
- 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.
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: Verdreifachen
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: GSK2321138A Group
Subjects aged between 18 and 47 months received the GSK2321138A.
"Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28.
The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
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Intramuscular injection
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Aktiver Komparator: Fluarix Group
Subjects aged between 18 and 47 months received the Fluarix™ vaccine.
"Primed" subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 - or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. "Unprimed" subject (subjects who had not received any 2-dose priming influenza immunization in any previous year - or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28.
The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
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Intramuscular injection
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against the 3 Fluarix Vaccine Strains.
Zeitfenster: At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 3 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2) and Flu B/Brisbane/60/08 Victoria (VICT).The POST results were the primary outcome variables.
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At Day 0 [PRE] and at 28 days post last vaccination (Day 28 or Day 56) [POST]
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0 and 28.
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28.
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Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0, 28 and Day 56
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Titers are presented as geometric mean titers (GMTs).
The reference cut-off value was 1:10.
The 4 influenza strains assessed were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and Day 56
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Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0 and 28
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A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28
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Number of Seropositive Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0, 28 and 56
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A seropositive subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:10.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and 56
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Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Day 28
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Day 28
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Number of Seroconverted Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 28 and 56
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A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 28 and 56
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Zeitfenster: At Day 28
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Day 28
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Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 28 and 56
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The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 28 and 56
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0 and 28
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the primed groups.
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At Days 0 and 28
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Number of Seroprotected Subjects Against 4 Strains of Influenza Disease.
Zeitfenster: At Days 0, 28 and 56
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A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.
The 4 assessed influenza strains were the FLU A/Brisbane/59/07 (H1N1), Flu A/Uruguay/716/07 (H3N2), Flu B/Brisbane/60/08 Victoria (VICT) and Flu B/Brisbane/3/07 Yamagata (YAMA).
This outcome only covers the results for the unprimed groups.
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At Days 0, 28 and 56
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms.
Zeitfenster: During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Assessed solicited local symptoms were pain, redness and swelling at the injection site.
Any = occurrence of the symptom regardless of intensity grade.
Grade 3 pain = cried when limb was moved/spontaneously painful.
Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
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During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Zeitfenster: During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and temperature (defined as axillary temperature equal to or above 37.5 degrees Celsius).
For other symptoms: Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination.
Related = symptoms assessed by the investigator as related to vaccination.
Grade 3 drowsiness = prevented normal activity.
Grade 3 loss of appetite = not eating at all.
Grade 3 irritability= crying that could not be comforted/prevented normal activity.
Grade 3 temperature: ≥ 39.0°C.
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During the 7-day follow-up period (Days 0 to 6) after any vaccination
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Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Zeitfenster: During the 28-day follow-up period (Days 0 to 27) after vaccination
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An unsolicited AE covers any untoward medical occurrence in a subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 = occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Grade 3 = an AE which prevented normal, everyday activities.
Related = AE assessed by the investigator as related to vaccination.
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During the 28-day follow-up period (Days 0 to 27) after vaccination
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Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Zeitfenster: From Day 0 to Day 180 (study conclusion)
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Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Any was defined as occurrence of any symptom regardless of intensity grade and related was an event assessed by the investigator as causally related to the study vaccination.
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From Day 0 to Day 180 (study conclusion)
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Number of Subjects With Any Adverse Events of Specific Interest (AESIs).
Zeitfenster: From Day 0 to Day 180 (study conclusion)
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An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration.
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From Day 0 to Day 180 (study conclusion)
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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
8. Oktober 2009
Primärer Abschluss (Tatsächlich)
21. Mai 2010
Studienabschluss (Tatsächlich)
21. Mai 2010
Studienanmeldedaten
Zuerst eingereicht
24. September 2009
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
24. September 2009
Zuerst gepostet (Schätzen)
28. September 2009
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
21. September 2018
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
22. August 2018
Zuletzt verifiziert
1. September 2016
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 113237
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: 113237Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Datensatzspezifikation
Informationskennung: 113237Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Statistischer Analyseplan
Informationskennung: 113237Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Klinischer Studienbericht
Informationskennung: 113237Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Einzelner Teilnehmerdatensatz
Informationskennung: 113237Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
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Studienprotokoll
Informationskennung: 113237Informationskommentare: 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 .
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