Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Non-inferiority Study of GSK Biologicals' Influenza Vaccine GSK576389A Using Different Formulations

9. maj 2018 opdateret af: GlaxoSmithKline

Non-inferiority Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A Using Different Formulations.

The purpose of this study is to show the non-inferiority of different formulations of GlaxoSmithKline Biologicials' influenza vaccine.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

720

Fase

  • Fase 2

Kontakter og lokationer

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

Studiesteder

  • Estland
      • Saku, Estland, 75501
        • GSK Investigational Site
      • Tallinn, Estland, 13419
        • GSK Investigational Site
      • Tartu, Estland, 50417
        • 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

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female 65 years of age or older at the time of vaccination.
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical evaluation (medical history and medical history directed examination) before entering into the study.

Exclusion Criteria:

  • Suspected (based on clinical symptoms) or confirmed (based on laboratory results) influenza infection within the last 6 months.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 21 days after vaccination.
  • Planned administration of an influenza vaccine other than the study vaccines during the entire study period.
  • Previous vaccination against influenza with any seasonal vaccine since July 2007.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s) including egg and chicken protein.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by clinical evaluation (medical history and medical history directed physical examination) or pre-existing laboratory screening tests.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
  • Any medical conditions in which IM injections are contraindicated

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: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Thiomersal-free FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal-free FluAS25 adjuvanted vaccine
Biologisk: Thiomersal-free FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose
Eksperimentel: Thiomersal reduced FluAS25 adjuvanted vaccine group
Subjects received 1 dose of thiomersal reduced FluAS25 adjuvanted vaccine
Biologisk: Thiomersal reduced FluAS25 adjuvanted vaccine (GSK576389A)
Intramuscular administration, 1 dose

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Serum Haemagglutination-inhibition (HI) Antibody Titer Against the Three Vaccine Strains
Tidsramme: Days 0 and 21
Titers were expressed as Geometric Mean Titers (GMTs). The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects Seropositive for HI Antibodies Against the Three Vaccine Strains
Tidsramme: Days 0 and 21
A seropositive subject was defined as a subject with a serum HI titer greater than or equal to 1:10. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Days 0 and 21
Number of Subjects Seroconverted for HI Antibodies Against the Three Vaccine Strains
Tidsramme: Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
HI Antibody Seroconversion Factors
Tidsramme: Day 21
Seroconversion factor was defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three vaccine strains assessed included A/Solomon Islands, A/Wisconsin and B/Malaysia.
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Three Vaccine Strains
Tidsramme: Days 0 and 21
A seroprotected subject was defined as a suject with a serum HI titer greater than or equal to 1:40 that usually is accepted as indicating protection.
Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms
Tidsramme: During a 7-day period after vaccination
Solicited local symptoms assessed include ecchymosis, pain, redness and swelling. Any: any symptom regardless of intensity grade. Grade 3 pain: considerable pain at rest, which prevented normal everyday activities. Grade 3 ecchymosis, redness and swelling: more than 100 millimeter.
During a 7-day period after vaccination
Duration of Solicited Local Symptoms
Tidsramme: During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited local symptoms assessed include ecchymosis, pain, redness and swelling.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Tidsramme: During a 7-day period after vaccination
Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any: any symptom regardless of intensity grade; any fever: oral temperature greater than or equal to 38 degrees Celsius (°C). Grade 3: symptoms that prevented normal activity ; Grade 3 fever: oral temperature greater than 39°C. Related: symptom assessed by the investigator as causally related to the study vaccination.
During a 7-day period after vaccination
Duration of Solicited General Symptoms
Tidsramme: During a 7-day period after vaccination
Duration was expressed as median number of days the symptom persisted. Solicited general symptoms assessed include arthralgia, fatigue, headache, myalgia, nausea, shivering and fever.
During a 7-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Tidsramme: During a 21-day period after vaccination
Unsolicited AE covers any AE 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.
During a 21-day period after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Medically Significant Conditions (MSCs)
Tidsramme: During a 21-day period after vaccination
Medically Significant Conditions (MSCs) included all unsolicited adverse events that resulted in a medically attended visit.
During a 21-day period after vaccination
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Tidsramme: During the entire study period (up to Day 21)
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.
During the entire study period (up to Day 21)

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.

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

3. marts 2008

Primær færdiggørelse (Faktiske)

11. april 2008

Studieafslutning (Faktiske)

11. april 2008

Datoer for studieregistrering

Først indsendt

29. februar 2008

Først indsendt, der opfyldte QC-kriterier

10. marts 2008

Først opslået (Skøn)

11. marts 2008

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

9. maj 2018

Sidst verificeret

1. november 2016

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 111454

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. Statistisk analyseplan
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individuelt deltagerdatasæt
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  3. Formular til informeret samtykke
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  4. Datasætspecifikation
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  5. Klinisk undersøgelsesrapport
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  6. Studieprotokol
    Informations-id: 111454
    Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
  7. Annoteret sagsbetænkningsformular
    Informations-id: 111454
    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

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Nigeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner