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Immuno & Reacto of TF Trivalent Influenza Split Vaccine 2003/04 or of Std Formulation Influsplit SSW®/Fluarix™ 2003/04

14. september 2016 opdateret af: GlaxoSmithKline

To Determine the Immunogenicity and Reactogenicity of a Thiomersal Free Trivalent Influenza Split Vaccine 2003/2004 or of GSK Biologicals' Standard Formulation Influsplit SSW®/Fluarix™ 2003/2004 in Children Aged From 6 Months Until 6 Years

The aim of the present study is to assess the reactogenicity and immunogenicity of a thiomersal-free influenza vaccine. For comparison, a group of subjects is administered the standard formulation of Influsplit SSW® 2003/2004.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

157

Fase

  • Fase 3

Kontakter og lokationer

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

Studiesteder

      • Berlin, Tyskland, 10315
        • GSK Investigational Site
      • Berlin, Tyskland, 12627
        • GSK Investigational Site
      • Berlin, Tyskland, 13355
        • GSK Investigational Site
    • Mecklenburg-Vorpommern
      • Buetzow, Mecklenburg-Vorpommern, Tyskland, 18246
        • GSK Investigational Site
      • Rostock, Mecklenburg-Vorpommern, Tyskland, 18106
        • GSK Investigational Site
    • Sachsen
      • Bischofswerda, Sachsen, Tyskland, 01877
        • GSK Investigational Site
      • Coswig, Sachsen, Tyskland, 01640
        • GSK Investigational Site
      • Dresden, Sachsen, Tyskland, 01307
        • GSK Investigational Site
      • Dresden, Sachsen, Tyskland, 01169
        • GSK Investigational Site
      • Leipzig, Sachsen, Tyskland, 04209
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Segeberg, Schleswig-Holstein, Tyskland, 23795
        • GSK Investigational Site
      • Flensburg, Schleswig-Holstein, Tyskland, 24937
        • GSK Investigational Site
      • Husum, Schleswig-Holstein, Tyskland, 25813
        • 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 6 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects whose parents/guardians the investigator believes can and will comply with the requirements of the protocol
  • Male or female children over 6 months of age at the time of vaccination, but who are not yet 6 years old.
  • All children included in the study must never have been given a prophylactic influenza inoculation.
  • Written consent to vaccination must be available from both parents or only the single parent after the parents/guardians have been briefed on the study in an understandable language.

Exclusion Criteria:

  • Use of study or unlicensed medication or administration of a vaccine other than the study vaccine within 30 days preceding vaccination and/or during the study period until 30 days after administration of the second vaccine dose.
  • Acute disease at the beginning of the study
  • Acute clinically significant changes in the lungs, cardiovascular system, liver or kidney function, identified by physical examination or laboratory tests.
  • Known allergic reactions that might have been caused by one or more components of the vaccine.
  • Administration of immunoglobulins and/or other blood products within 3 months before the beginning of the study 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: Group A
Subjects aged between 6 months and 3 years.
2 doses, intramuscular injection
Eksperimentel: Group B
Subjects aged 3 to 6 years.
2 doses, intramuscular injection
Aktiv komparator: Group C
Subjects aged between 6 months and 3 years.
2 doses, intramuscular injection
Andre navne:
  • Thiomersal free trivalent influenza split vaccine 2003/2004
Aktiv komparator: Group D
Subjects aged 3 to 6 years.
2 doses, intramuscular injection
Andre navne:
  • Thiomersal free trivalent influenza split vaccine 2003/2004

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
GMT of the haemagglutination-inhibiting (HI) antibodies and calculation of seroconversion factor, seroconversion rate & seroprotection rate, checked against CHMP criteria (for 18 - 60 years old); seroprotection power is also calculated.
Tidsramme: On Day 21 (+- 2) after the second vaccination
On Day 21 (+- 2) after the second vaccination

Sekundære resultatmål

Resultatmål
Tidsramme
Descriptive comparison of the occurrence and severity of solicited local and general symptoms
Tidsramme: Within 4 days after each vaccination
Within 4 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of unsolicited signs and symptoms
Tidsramme: Within 30 days after each vaccination
Within 30 days after each vaccination
Descriptive comparison of the occurrence, severity and relationship to vaccination of serious adverse events (SAEs).
Tidsramme: Throughout the study
Throughout the study
GMT of the HI antibodies in each case against the 3 influenza virus strains of the vaccine separately for both age groups.
Tidsramme: On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination
On Day 21 (+- 2), Month 3 and Month 6 after the second vaccination

Samarbejdspartnere og efterforskere

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

Sponsor

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.

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 2003

Primær færdiggørelse (Faktiske)

1. august 2004

Studieafslutning (Faktiske)

1. august 2004

Datoer for studieregistrering

Først indsendt

7. august 2008

Først indsendt, der opfyldte QC-kriterier

7. august 2008

Først opslået (Skøn)

11. august 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

15. september 2016

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. september 2016

Sidst verificeret

1. september 2016

Mere information

Begreber relateret til denne undersøgelse

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. Studieprotokol
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Klinisk undersøgelsesrapport
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Individuelt deltagerdatasæt
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Statistisk analyseplan
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Annoteret sagsbetænkningsformular
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Datasætspecifikation
    Informations-id: 100351
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Formular til informeret samtykke
    Informations-id: 100351
    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 Thiomersal free trivalent influenza split vaccine 2003/2004

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Abonner