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Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate in Adults.

keskiviikko 9. toukokuuta 2018 päivittänyt: GlaxoSmithKline

Immunogenicity and Safety Study of a GSK Influenza Vaccine Candidate GSK 2115160A in Adults.

The purpose of this study is to evaluate the safety and immunogenicity of GSK influenza vaccine candidate compared to a licensed trivalent influenza vaccine in adults.

Tutkimuksen yleiskatsaus

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

420

Vaihe

  • Vaihe 1

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

      • Hradec Kralove, Tšekki, 500 03
        • GSK Investigational Site

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 60 vuotta (Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Joo

Sukupuolet, jotka voivat opiskella

Kaikki

Kuvaus

Inclusion Criteria:

  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 18 and 60 years of age at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • If the subject is female, she must be of non-childbearing potential, 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 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of study vaccine, or planned use during the study period.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 3 months prior to administration of the vaccine.
  • Administration of a vaccine not foreseen in the study protocol from 30 days before vaccination up to 21 days post vaccination.
  • Confirmed influenza infection within a year preceding the study start.
  • Administration of an influenza vaccine during Northern Hemisphere season 2007-2008.
  • 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 (pharmaceutical product or device).
  • History of hypersensitivity to a previous dose of influenza vaccine
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Acute disease at the time of enrolment.
  • Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the administration of study vaccine or planned administration during the study period.
  • Pregnant or lactating female.
  • Female planning to become pregnant or planning to discontinue contraceptive precautions.
  • History of chronic alcohol consumption and/or drug abuse.
  • Any condition which, in the opinion of the investigator, prevents the subject from participating in the study.
  • History of administration of experimental/licensed vaccine.

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Ennaltaehkäisy
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Yksittäinen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Kokeellinen: Quadrivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 full dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Kokeellinen: Quadrivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 low dose of GSK Biologicals' quadrivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Active Comparator: Trivalent influenza vaccine GSK 2115160A Group 1
Subjects in this group received 1 low dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.
Active Comparator: Trivalent influenza vaccine GSK 2115160A Group 2
Subjects in this group received 1 full dose of GSK Biologicals' trivalent influenza vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Day 0
Single intramuscular dose on Day 0.

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Serum Haemagglutination-inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.
Aikaikkuna: At Day 0 and Day 21
Antibody titers were expressed as Geometric mean titers (GMTs).The vaccine influenza strains included A/Solomon Islands,A/Wisconsin,B/Malaysia and B/Jiangsu antigens.
At Day 0 and Day 21

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Number of Subjects Seroconverted for HI Antibodies Against the Vaccine Influenza Strains.
Aikaikkuna: At Day 21
A seroconverted subject was defined as a subject who had either a pre-vaccination titer less than (<) 1:10 and a post-vaccination titer greater than or equal to (≥) 1:40 or a pre-vaccination titer ≥ 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine influenza strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
At Day 21
HI Antibody Seroconversion Factors Against the Vaccine Influenza Strains
Aikaikkuna: Day 21
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
Day 21
Number of Subjects Seroprotected for HI Antibodies Against the Vaccine Influenza Strains.
Aikaikkuna: At Days 0 and 21
A seroprotected subject was defined as a subject with a serum HI titer ≥1:40 that usually is accepted as indicating protection. The Influenza vaccine strains included A/Solomon Islands, A/Wisconsin, B/Malaysia and B/Jiangsu antigens.
At Days 0 and 21
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Aikaikkuna: During a 7 day (Days 0-6) follow-up period after vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as considerable pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 100 millimeters (mm).
During a 7 day (Days 0-6) follow-up period after vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms Reported by the Former GSK Rules of Grading.
Aikaikkuna: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited local symptoms assessed by the former GSK rules of grading were pain, redness and swelling. Any was defined as occurrence of any specified solicited local symptoms reported irrespective of intensity grade. Grade 3 pain was defined as pain that prevented normal activity. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Aikaikkuna: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited general symptoms assessed were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any =occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 38.0 degrees Celsius (°C).. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature ≥39.0°C. Related = symptoms considered by the investigator to have a causal relationship to vaccination
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects With Any ,Grade 3 and Related Solicited General Symptoms Reported by the Former GSK Rules of Grading.
Aikaikkuna: During a 7-day follow-up period (Days 0-6) after vaccination
Solicited general symptoms assessed by the former GSK rules of grading were arthralgia, fatigue, headache, myalgia, nausea, shivering and fever. Any = occurrence of any specified solicited general symptoms reported irrespective of intensity grade or relationship to vaccination. Any fever = oral temperature ≥ 37.5 °C. Grade 3 symptoms = symptoms that prevented normal activities. Grade 3 fever = oral temperature above 39.0°C. . Related = symptoms considered by the investigator to have a causal relationship to vaccination.
During a 7-day follow-up period (Days 0-6) after vaccination
Number of Subjects Reporting Any Medically Significant Conditions (MSCs) and Auto-immune Diseases (AIDs).
Aikaikkuna: During the entire study period (Days 0-180)
MSCs were defined as those adverse events (AEs) prompting emergency room visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. AIDs include a large group of diseases characterized by abnormal functioning of the immune system that causes immune system to produce antibodies against own tissues.
During the entire study period (Days 0-180)
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AE(s).
Aikaikkuna: During a 21 day (Days 0-20) follow-up 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. Any was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination
During a 21 day (Days 0-20) follow-up period after vaccination-
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Aikaikkuna: During the entire study period (Days 0-180)
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. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
During the entire study period (Days 0-180)

Yhteistyökumppanit ja tutkijat

Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.

Sponsori

Julkaisuja ja hyödyllisiä linkkejä

Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.

Opintojen ennätyspäivät

Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan ​​julkisella verkkosivustolla.

Opi tärkeimmät päivämäärät

Opiskelun aloitus

Maanantai 14. heinäkuuta 2008

Ensisijainen valmistuminen (Todellinen)

Keskiviikko 28. tammikuuta 2009

Opintojen valmistuminen (Todellinen)

Keskiviikko 28. tammikuuta 2009

Opintoihin ilmoittautumispäivät

Ensimmäinen lähetetty

Perjantai 11. heinäkuuta 2008

Ensimmäinen toimitettu, joka täytti QC-kriteerit

Perjantai 11. heinäkuuta 2008

Ensimmäinen Lähetetty (Arvio)

Maanantai 14. heinäkuuta 2008

Tutkimustietojen päivitykset

Viimeisin päivitys julkaistu (Todellinen)

Perjantai 8. kesäkuuta 2018

Viimeisin lähetetty päivitys, joka täytti QC-kriteerit

Keskiviikko 9. toukokuuta 2018

Viimeksi vahvistettu

Keskiviikko 1. maaliskuuta 2017

Lisää tietoa

Tähän tutkimukseen liittyvät termit

Yksittäisten osallistujien tietojen suunnitelma (IPD)

Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?

JOO

IPD-suunnitelman kuvaus

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

Tutkimustiedot/asiakirjat

  1. Ilmoitettu suostumuslomake
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  2. Kliinisen tutkimuksen raportti
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  3. Selosteilla varustettu tapausraporttilomake
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  4. Tutkimuspöytäkirja
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  5. Yksittäisen osallistujan tietojoukko
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  6. Tietojoukon määritys
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register
  7. Tilastollinen analyysisuunnitelma
    Tiedon tunniste: 111295
    Tietokommentit: For additional information about this study please refer to the GSK Clinical Study Register

Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .

Kliiniset tutkimukset GSK Biologicals' quadrivalent influenza vaccine

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