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Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)

31. Juli 2017 aktualisiert von: GlaxoSmithKline

Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 3 to 17 Years

This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 3 and 17 years.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

210

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Spanien
      • Bilbao, Spanien, 48013
        • GSK Investigational Site
      • Burgos, Spanien, 09005
        • GSK Investigational Site
      • Madrid, Spanien, 28046
        • GSK Investigational Site
      • Móstoles/Madrid, Spanien, 28935
        • GSK Investigational Site
      • Sevilla, Spanien, 41013
        • 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

3 Jahre bis 17 Jahre (Kind)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Children, male or female, aged between 3 and 17 years at the time of the first study vaccination.
  • Written informed consent obtained from the subject parent(s) or LAR(s) of the subject. Assent obtained from the subject when applicable.
  • Healthy children as established by medical history and clinical examination when entering into the study.
  • Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • Clinically or virologically confirmed influenza infection within six months preceding the study start.
  • Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
  • Acute disease and/or fever at the time of enrolment
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
  • Previous administration of any H1N1 A/California-like vaccine.
  • Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
  • If the subject is female and 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 two months after completion of the vaccination series.
  • Any known or suspected allergy to any constituent of influenza vaccines;a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
  • Known use of an analgesic or antipyretic medication within 12 hours prior to first vaccination.
  • Child in Care.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Gruppe A
Biologisch: Pandemic influenza vaccine GSK2340272A
Two primary intramuscular (IM) injections and a booster IM injection

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of Subjects With Haemagglutination-inhibition (HI) Antibody Concentrations Above the Cut-off Value
Zeitfenster: At Day 0
The seropositivity cut-off value of the assay was equal to or above (≥) 1:10 in the sera of subjects seronegative before vaccination. The flu strain assessed was A/California/7/2009 (H1N1)v-like (Flu A/CAL/7/09).
At Day 0
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Zeitfenster: At Day 42
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Day 42
Titers for Serum HI Antibodies
Zeitfenster: At Day 0
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 0
Titers for Serum HI Antibodies
Zeitfenster: At Day 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Zeitfenster: At Day 42
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Number of Seroprotected (SPR) Subjects in Terms of HI Antibodies
Zeitfenster: At Day 42
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Day 42
Seroconversion Factor (SCF) for HI Antibody Titers
Zeitfenster: At Day 42
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Day 42

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Anzahl der Probanden mit allen und Grad 3 erbetenen lokalen Symptomen
Zeitfenster: Während der 7 Tage (Tage 0-6) nach der Impfung nach jeder Dosis und über die Dosen hinweg
Bewertete erbetene lokale Symptome waren Schmerzen, Rötungen und Schwellungen. Beliebig = Auftreten des Symptoms unabhängig vom Intensitätsgrad. Schmerz 3. Grades = Schmerz, der eine normale Aktivität verhindert. Rötung/Schwellung Grad 3 = Rötung/Schwellung, die sich über 50 Millimeter (mm) der Injektionsstelle ausbreitet.
Während der 7 Tage (Tage 0-6) nach der Impfung nach jeder Dosis und über die Dosen hinweg
Number of Subjects With HI Antibody Concentrations Above the Cut-off Value
Zeitfenster: At Days 0, 21, 42 and at Month 12
The seropositivity cut-off value of the assay was ≥ 1:10 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Titers for Serum HI Antibodies
Zeitfenster: At Days 0, 21, 42 and at Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Number of Seroconverted (SCR) Subjects in Terms of HI Antibodies
Zeitfenster: At Days 21, 42 and at Month 12
A seroconverted subject was defined as: For initially seronegative subjects [antibody titer below (<) 1:10 prior to vaccination], antibody titer ≥ 1:40 after vaccination; For initially seropositive subjects (antibody titer ≥ 1:10 prior to vaccination), at least a 4-fold increase in post-vaccination antibody titer. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Seroprotected Subjects in Terms of HI Antibodies
Zeitfenster: At Days 0, 21, 42 and at Month 12
Seroprotection was defined as the percentage of subjects with a serum HI titer ≥ 1:40, that usually is accepted as indicating protection. The flu strain assessed was Flu A/CAL/7/09.
At Days 0, 21, 42 and at Month 12
Seroconversion Factor (SCF) for HI Antibody Titers
Zeitfenster: At Days 21, 42 and at Month 12
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to pre-vaccination. The flu strain assessed was Flu A/CAL/7/09.
At Days 21, 42 and at Month 12
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Zeitfenster: At Days 0, 21 and 42
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Days 0, 21 and 42
Titers for Serum Neutralizing Antibodies
Zeitfenster: At Days 0, 21 and 42
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was A/Netherlands/602/2009 (H1N1)v-like (Flu A/Neth/602/09).
At Days 0, 21 and 42
Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value
Zeitfenster: At Month 12
The seropositivity cut-off value of the assay was ≥ 1:8 in the sera of subjects seronegative before vaccination. The flu strain assesssed was Flu A/Neth/602/09.
At Month 12
Titers for Serum Neutralizing Antibodies
Zeitfenster: At Month 12
Antibody titers were presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:8. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Zeitfenster: At Days 21 and 42
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Days 21 and 42
Number of Seroconverted (SCR) Subjects in Terms of H1N1 Neutralizing Antibodies
Zeitfenster: At Month 12
A seroconverted subject was defined as: For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, at least a 4-fold increase in post-vaccination titer. The flu strain assessed was Flu A/Neth/602/09.
At Month 12
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were diarrhea, drowsiness, irritability, loss of appetite, shivering, sweating and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Zeitfenster: During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Assessed solicited general symptoms were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0-6) post-vaccination period following each dose and across doses
Number of Subjects With Any Medically-attended Events (MAEs)
Zeitfenster: During the entire study period (from Day 0 up to Month 12)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Any Adverse Events of Specific Interest (AESIs), Including Potential Immune-mediated Disease (pIMDs)
Zeitfenster: During the entire study period (from Day 0 up to Month 12)
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.
During the entire study period (from Day 0 up to Month 12)
Number of Subjects With Normal or Abnormal Biochemical Levels
Zeitfenster: At Days 0, 21 and 42
Among biochemical parameters assessed were alanine aminotransferase [ALAT], aspartate aminotransferase [ASAT], bilirubin [BILI], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed in terms of normal laboratory values were - unknown, below, within and above.
At Days 0, 21 and 42
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Zeitfenster: During the 21-day (Days 0-20) follow-up period after the first vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 21-day (Days 0-20) follow-up period after the first vaccination
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Zeitfenster: During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
An unsolicited AE covers any untoward medical occurrence in a clinical investigation 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 was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
During the 83-day (Days 0-82) follow-up period after the first vaccination and the 62-day (Days 0-61) follow-up period after the second vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Zeitfenster: During the entire study period (from Day 0 up to Month 12)
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.
During the entire study period (from Day 0 up to Month 12)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

GlaxoSmithKline

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

Nützliche Links

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

10. September 2009

Primärer Abschluss (Tatsächlich)

27. November 2010

Studienabschluss (Tatsächlich)

27. November 2010

Studienanmeldedaten

Zuerst eingereicht

20. August 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. August 2009

Zuerst gepostet (Schätzen)

24. August 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

19. Februar 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

31. Juli 2017

Zuletzt verifiziert

1. Oktober 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 113528

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

  1. Statistischer Analyseplan
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  2. Kommentiertes Fallberichtsformular
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  3. Einwilligungserklärung
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  4. Klinischer Studienbericht
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  5. Einzelner Teilnehmerdatensatz
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studienprotokoll
    Informationskennung: 113528
    Informationskommentare: For additional information about this study please refer to the GSK Clinical Study Register
  7. Datensatzspezifikation
    Informationskennung: 113528
    Informationskommentare: 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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