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Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children

2. juli 2018 opdateret af: GlaxoSmithKline

Immunogenicity and Safety of GSK Biologicals' Thimerosal-free TIV Flu Vaccine Versus a Licensed Comparator in Children

The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine) in children, 6 to 35 months of age.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

3317

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35244
        • GSK Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35205
        • GSK Investigational Site
      • Dothan, Alabama, Forenede Stater, 36305
        • GSK Investigational Site
    • Arkansas
      • Benton, Arkansas, Forenede Stater, 72019
        • GSK Investigational Site
      • Conway, Arkansas, Forenede Stater, 72034
        • GSK Investigational Site
      • Fayetteville, Arkansas, Forenede Stater, 72703
        • GSK Investigational Site
      • Jonesboro, Arkansas, Forenede Stater, 72401
        • GSK Investigational Site
      • Little Rock, Arkansas, Forenede Stater, 72205
        • GSK Investigational Site
    • California
      • Huntington Beach, California, Forenede Stater, 92647
        • GSK Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • GSK Investigational Site
      • Paramount, California, Forenede Stater, 90723
        • GSK Investigational Site
      • Sacramento, California, Forenede Stater, 95816
        • GSK Investigational Site
      • San Francisco, California, Forenede Stater, 94102
        • GSK Investigational Site
      • West Covina, California, Forenede Stater, 91790
        • GSK Investigational Site
    • Colorado
      • Longmont, Colorado, Forenede Stater, 80501
        • GSK Investigational Site
    • Connecticut
      • Norwich, Connecticut, Forenede Stater, 06360
        • GSK Investigational Site
    • Idaho
      • Nampa, Idaho, Forenede Stater, 83686
        • GSK Investigational Site
    • Illinois
      • DeKalb, Illinois, Forenede Stater, 60115
        • GSK Investigational Site
    • Indiana
      • New Albany, Indiana, Forenede Stater, 47150
        • GSK Investigational Site
    • Kansas
      • Arkansas City, Kansas, Forenede Stater, 67005
        • GSK Investigational Site
      • Newton, Kansas, Forenede Stater, 67114
        • GSK Investigational Site
      • Wichita, Kansas, Forenede Stater, 67207
        • GSK Investigational Site
    • Kentucky
      • Bardstown, Kentucky, Forenede Stater, 40004
        • GSK Investigational Site
      • Louisville, Kentucky, Forenede Stater, 40207
        • GSK Investigational Site
    • Louisiana
      • Bossier City, Louisiana, Forenede Stater, 71111
        • GSK Investigational Site
      • Metairie, Louisiana, Forenede Stater, 70006
        • GSK Investigational Site
    • Michigan
      • Stevensville, Michigan, Forenede Stater, 49127
        • GSK Investigational Site
    • Minnesota
      • Saint Paul, Minnesota, Forenede Stater, 55108
        • GSK Investigational Site
    • Missouri
      • Saint Louis, Missouri, Forenede Stater, 63141
        • GSK Investigational Site
    • Nebraska
      • Omaha, Nebraska, Forenede Stater, 68134
        • GSK Investigational Site
    • Nevada
      • Henderson, Nevada, Forenede Stater, 89015
        • GSK Investigational Site
    • New York
      • Cortland, New York, Forenede Stater, 13045
        • GSK Investigational Site
    • North Carolina
      • Boone, North Carolina, Forenede Stater, 28607
        • GSK Investigational Site
      • Cary, North Carolina, Forenede Stater, 27518
        • GSK Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27609
        • GSK Investigational Site
    • North Dakota
      • Fargo, North Dakota, Forenede Stater, 58103
        • GSK Investigational Site
    • Ohio
      • Austintown, Ohio, Forenede Stater, 44515
        • GSK Investigational Site
      • Cincinnati, Ohio, Forenede Stater, 45245
        • GSK Investigational Site
      • Cleveland, Ohio, Forenede Stater, 44121
        • GSK Investigational Site
      • Dayton, Ohio, Forenede Stater, 45406
        • GSK Investigational Site
    • Oregon
      • Gresham, Oregon, Forenede Stater, 97030
        • GSK Investigational Site
    • Pennsylvania
      • Erie, Pennsylvania, Forenede Stater, 16505
        • GSK Investigational Site
      • Greenville, Pennsylvania, Forenede Stater, 16125
        • GSK Investigational Site
      • Latrobe, Pennsylvania, Forenede Stater, 15650
        • GSK Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15236
        • GSK Investigational Site
      • Uniontown, Pennsylvania, Forenede Stater, 15401
        • GSK Investigational Site
      • Wexford, Pennsylvania, Forenede Stater, 15090
        • GSK Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29406
        • GSK Investigational Site
    • Tennessee
      • Clarksville, Tennessee, Forenede Stater, 37043
        • GSK Investigational Site
      • Jackson, Tennessee, Forenede Stater, 38305
        • GSK Investigational Site
      • Kingsport, Tennessee, Forenede Stater, 37660
        • GSK Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78705
        • GSK Investigational Site
      • Fort Worth, Texas, Forenede Stater, 76135
        • GSK Investigational Site
      • Houston, Texas, Forenede Stater, 77055
        • GSK Investigational Site
      • San Angelo, Texas, Forenede Stater, 76904
        • GSK Investigational Site
    • Utah
      • Bountiful, Utah, Forenede Stater, 84010
        • GSK Investigational Site
      • Layton, Utah, Forenede Stater, 84041
        • GSK Investigational Site
      • Murray, Utah, Forenede Stater, 84107
        • GSK Investigational Site
      • Provo, Utah, Forenede Stater, 84604
        • GSK Investigational Site
      • Roy, Utah, Forenede Stater, 84067
        • GSK Investigational Site
      • South Jordan, Utah, Forenede Stater, 84095
        • GSK Investigational Site
    • Virginia
      • Burke, Virginia, Forenede Stater, 22015
        • GSK Investigational Site
  • Hong Kong
      • Pokfulam, Hong Kong
        • GSK Investigational Site
      • Shatin, Hong Kong
        • GSK Investigational Site
  • Mexico
      • Mexico, Mexico, 6720
        • GSK Investigational Site
      • Mexico city, Mexico, 04530
        • GSK Investigational Site
  • Taiwan
      • Taipei, Taiwan, 104
        • GSK Investigational Site
      • Taipei, Taiwan
        • GSK Investigational Site
  • Thailand
      • Bangkok, Thailand, 10400
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 måneder til 2 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • A male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable.
  • Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject's parent/guardian.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion.
  • History of hypersensitivity to any vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine.
  • 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 an influenza vaccine outside of this study, during current (2008-09) flu season.
  • Administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Fluarix Dose A Group

Subjects were administered 1 or 2 doses* of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Biologisk: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Eksperimentel: Fluarix Dose B Group

Subjects were administered 1 or 2 doses*, half the volume of dose A, of Fluarix vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Biologisk: Fluarix
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.
Aktiv komparator: Fluzone Group

Subjects were administered 1 or 2 doses* of Fluzone vaccine (at Day 0 or at Days 0 and 28) intramuscularly, in the non-dominant upper arm (children >12 months of age) or in the anterolateral thigh (children <12 months of age).

* Only those subjects who had no history of prior influenza vaccination (i.e. unprimed subjects) received 2 doses.
Biologisk: Fluzone
One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Geometric Mean Titer (GMT) of Serum Anti-hemagglutinin (HA) Antibodies Against Each of the Influenza Vaccine Strains
Tidsramme: Day 0 (PRE), Day 28 or Day 56 (POST)

GMTs and their 95% confidence interval are presented for all 3 viral strains comprised in the vaccine.

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 0 (PRE), Day 28 or Day 56 (POST)
Number of Subjects Who Seroconverted
Tidsramme: Day 28 or Day 56

Seroconversion is defined as the number of subjects with either a pre-vaccination anti-HA titer < 1:10 and a post-vaccination titer ≥ 1:40, or a pre-vaccination titer ≥ 1:10 and a minimum 4-fold increase at post-vaccination titer.

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 28 or Day 56

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Seroprotected Subjects
Tidsramme: Day 0 (PRE), Day 28 or Day 56 (POST)

A seroprotected subject is a subject with a serum anti-HA titer

≥ 1:40

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 0 (PRE), Day 28 or Day 56 (POST)
Seroconversion Factor
Tidsramme: Day 28 or Day 56

Seroconversion factor is defined as the fold increase in serum anti-HA GMTs post-vaccination (Day 28 or 56) compared to pre-vaccination (Day 0).

Post-vaccination timepoints: Day 28 for primed or Day 56 for unprimed subjects
Day 28 or Day 56
Number of Subjects Reporting Solicited Local Symptoms
Tidsramme: During a 4-day follow-up period after vaccination
Solicited local symptoms assessed include pain, redness and swelling.
During a 4-day follow-up period after vaccination
Number of Subjects Reporting Solicited General Symptoms
Tidsramme: During a 4-day follow-up period after vaccination
Solicited general symptoms assessed include drowsiness, irritability, loss of appetitie, and temperature.
During a 4-day follow-up period after vaccination
Number of Subjects Reporting Unsolicited Adverse Events (AE)
Tidsramme: During a 28-day follow-up period after vaccination
An AE is 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
During a 28-day follow-up period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAE) and New Onset of Chronic Diseases (NOCD)
Tidsramme: During the entire study (Day 0 until Month 6)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

NOCDs assessed include for example: diabetes, asthma, allergies, autoimmune disease, cancer, neuropathic disorders
During the entire study (Day 0 until Month 6)
Number of Subjects Reporting Rare Serious Events
Tidsramme: During the entire study (Day 0 until Month 6)
Rare serious events have an occurrence rate of 1/300 (0.3%).
During the entire study (Day 0 until Month 6)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2008

Primær færdiggørelse (Faktiske)

5. marts 2009

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

1. oktober 2008

Først indsendt, der opfyldte QC-kriterier

1. oktober 2008

Først opslået (Skøn)

2. oktober 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

31. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2018

Sidst verificeret

1. oktober 2016

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 111751

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Studiedata/dokumenter

  1. Datasætspecifikation
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Formular til informeret samtykke
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisk analyseplan
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Annoteret sagsbetænkningsformular
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Individuelt deltagerdatasæt
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Studieprotokol
    Informations-id: 111751
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Influenza

Kliniske forsøg med Fluarix

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner