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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

19 juli 2018 bijgewerkt door: GlaxoSmithKline

Phase IIIb Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Meningococcal Vaccine [GSK 134612] When Given as One Dose to Healthy Subjects Aged 56 Years or Older

This study evaluates the immunogenicity and safety of the meningococcal conjugate vaccine GSK 134612 given as single dose to healthy adults 56 years or older compared to the meningococcal polysaccharide vaccine MencevaxACWYTM.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

400

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Libanon
      • Beirut, Libanon, 1107-2020
        • GSK Investigational Site

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

56 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • A male or female 56 years of age or older at the time of the vaccination.
  • Written informed consent obtained from the subject.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-child-bearing potential is defined as current tubal ligation, hysterectomy, ovariectomy or post-menopause.

Exclusion Criteria:

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrent participation 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 non-investigational product.
  • Extended administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. Inhaled and topical steroids are allowed.
  • Any contra-indication to intramuscular and /or subcutaneous injection.
  • Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days prior to vaccination and ending 30 days after vaccination. (Vaccination with inactivated influenza vaccines, including H1N1, is allowed at any time during the study as per local recommendations).
  • Previous vaccination with meningococcal serogroups A, C, W-135 and Y polysaccharide vaccine within 5 years prior to vaccination.
  • Previous vaccination at any time with meningococcal serogroups A, C, W-135 and Y polysaccharide conjugate vaccine.
  • Previous vaccination with tetanus toxoid containing vaccine within 5 years prior to vaccination.
  • History of meningococcal disease due to serogroups A, C, W-135 or Y.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
  • Family history of congenital or hereditary immunodeficiency.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
  • History of neurological disorders and seizures
  • History of Guillain-Barre syndrome.
  • Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or pre-existing laboratory screening tests.
  • Acute disease and/or fever at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine/product or planned administration during the study period.
  • Pregnant or lactating female.
  • Current chronic alcohol consumption and/or drug abuse.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Groep A
Biologisch: Meningococcal vaccine GSK 134612
Intramuscular injection
Actieve vergelijker: Groep B
Biologisch: MencevaxACWY TM
Subcutaneous injection

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)
Tijdsspanne: One month after vaccination (Month 1)
Vaccine response for serum bactericidal assay using rabbit complement (rSBA) antibodies against Neisseria meningitides serogroups A, C , W-135, Y (rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY) was defined as: for initially seronegative subjects [rSBA titer below (<) 1:8], post-vaccination rSBA titer greater than or equal to (≥) 1: 32; for initially seropositive subjects with rSBA titer between 1:8 and 1:128, at least four-fold increase in rSBA titer from pre to post vaccination; and for initially seropositive subjects with rSBA titer ≥1:128, at least two-fold increase in rSBA titer from pre to post vaccination.
One month after vaccination (Month 1)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Tijdsspanne: At Day 0 and Month 1
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
At Day 0 and Month 1
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Tijdsspanne: At Day 0 and Month 1
The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
At Day 0 and Month 1
rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Tijdsspanne: At Day 0 and Month 1
Antibody titers were presented as geometric mean titers (GMTs).
At Day 0 and Month 1
Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value
Tijdsspanne: At Day 0 and Month 1
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
At Day 0 and Month 1
Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value
Tijdsspanne: At Day 0 and Month 1
The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
At Day 0 and Month 1
Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Tijdsspanne: At Day 0 and Month 1
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
At Day 0 and Month 1
Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value
Tijdsspanne: At Day 0 and Month 1
The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
At Day 0 and Month 1
Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Tijdsspanne: At Day 0 and Month 1
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
At Day 0 and Month 1
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tijdsspanne: Within 4 days (Day 0 to 3) post-vaccination
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = significant pain at rest or pain that prevented normal every day activities. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Within 4 days (Day 0 to 3) post-vaccination
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tijdsspanne: Within 4 days (Day 0 to 3) post-vaccination
Assessed solicited general symptoms were fatigue,gastrointestinal symptoms, headache and temperature [defined as orally temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any general symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 temperature = temperature above (>) 39.5 °C. Related = symptom assessed by the investigator as causally related to the study vaccination.
Within 4 days (Day 0 to 3) post-vaccination
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Tijdsspanne: Within 31 days (Day 0 to 30) after 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.
Within 31 days (Day 0 to 30) after vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Tijdsspanne: Within 31 days (Day 0 to 30) after vaccination
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.
Within 31 days (Day 0 to 30) after vaccination
Number of Subjects With New Onset Chronic Illnesses (NOCI)
Tijdsspanne: Within 31 days (Day 0 to 30) after vaccination
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Within 31 days (Day 0 to 30) after vaccination

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

GlaxoSmithKline

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

30 november 2010

Primaire voltooiing (Werkelijk)

29 juli 2011

Studie voltooiing (Werkelijk)

3 augustus 2011

Studieregistratiedata

Eerst ingediend

4 november 2010

Eerst ingediend dat voldeed aan de QC-criteria

4 november 2010

Eerst geplaatst (Schatting)

7 november 2010

Updates van studierecords

Laatste update geplaatst (Werkelijk)

20 augustus 2018

Laatste update ingediend die voldeed aan QC-criteria

19 juli 2018

Laatst geverifieerd

1 juli 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 113807

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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

Bestudeer gegevens/documenten

  1. Klinisch onderzoeksrapport
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  2. Specificatie gegevensset
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  3. Statistisch analyseplan
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  4. Leerprotocool
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  5. Gegevensset individuele deelnemers
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register
  6. Formulier geïnformeerde toestemming
    Informatie-ID: 113807
    Informatie opmerkingen: For additional information about this study please refer to the GSK Clinical Study Register

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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