- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01235975
Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years
19. juli 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
400
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Beirut, Libanon, 1107-2020
- GSK Investigational Site
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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
56 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
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.
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Gruppe A
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Intramuscular injection
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Aktiv komparator: Gruppe B
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Subcutaneous injection
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)
Tidsramme: One month after vaccination (Month 1)
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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.
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One month after vaccination (Month 1)
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Tidsramme: At Day 0 and Month 1
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The cut-off value for the rSBA titers was greater than or equal to (≥) 1:8.
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At Day 0 and Month 1
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Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value
Tidsramme: At Day 0 and Month 1
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The cut-off value for the rSBA titers was greater than or equal to (≥) 1:128.
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At Day 0 and Month 1
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rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers
Tidsramme: At Day 0 and Month 1
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Antibody titers were presented as geometric mean titers (GMTs).
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At Day 0 and Month 1
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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
Tidsramme: At Day 0 and Month 1
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The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 0.3 micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value
Tidsramme: At Day 0 and Month 1
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The cut-off value for the anti-polysaccharide concentrations was greater than or equal to (≥) 2.0 micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations
Tidsramme: At Day 0 and Month 1
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (μg/mL).
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At Day 0 and Month 1
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Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value
Tidsramme: At Day 0 and Month 1
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The cut-off value for the anti-TT concentrations was greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
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At Day 0 and Month 1
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Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations
Tidsramme: At Day 0 and Month 1
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Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
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At Day 0 and Month 1
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Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Tidsramme: Within 4 days (Day 0 to 3) post-vaccination
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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.
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Within 4 days (Day 0 to 3) post-vaccination
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Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Tidsramme: Within 4 days (Day 0 to 3) post-vaccination
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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.
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Within 4 days (Day 0 to 3) post-vaccination
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Number of Subjects With Any Unsolicited Adverse Events (AEs)
Tidsramme: Within 31 days (Day 0 to 30) after vaccination
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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.
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Within 31 days (Day 0 to 30) after vaccination
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Number of Subjects With Serious Adverse Events (SAEs)
Tidsramme: Within 31 days (Day 0 to 30) after vaccination
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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.
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Within 31 days (Day 0 to 30) after vaccination
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Number of Subjects With New Onset Chronic Illnesses (NOCI)
Tidsramme: Within 31 days (Day 0 to 30) after vaccination
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NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
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Within 31 days (Day 0 to 30) after vaccination
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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 (Faktiske)
30. november 2010
Primær færdiggørelse (Faktiske)
29. juli 2011
Studieafslutning (Faktiske)
3. august 2011
Datoer for studieregistrering
Først indsendt
4. november 2010
Først indsendt, der opfyldte QC-kriterier
4. november 2010
Først opslået (Skøn)
7. november 2010
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
20. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 113807
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
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Klinisk undersøgelsesrapport
Informations-id: 113807Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Datasætspecifikation
Informations-id: 113807Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Statistisk analyseplan
Informations-id: 113807Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Studieprotokol
Informations-id: 113807Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Individuelt deltagerdatasæt
Informations-id: 113807Oplysningskommentarer: For additional information about this study please refer to the GSK Clinical Study Register
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Formular til informeret samtykke
Informations-id: 113807Oplysningskommentarer: 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 .
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