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Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults

15. juli 2015 opdateret af: Pfizer

A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects

The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

48

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

  • Forenede Stater
    • Florida
      • South Miami, Florida, Forenede Stater, 33143
        • Miami Research Associates, Inc.

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

18 år til 40 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:

  • Male or female subjects between the ages of 18 and 40.
  • Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
  • Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.

In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:

  • Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
  • Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
  • Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.

Exclusion Criteria:

None

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
Eksperimentel: 1
rLP2086 vaccine 60 mcg
Biologisk: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Eksperimentel: 2
rLP2086 vaccine 120 mcg
Biologisk: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Eksperimentel: 3
rLP2086 vaccine 200 mcg
Biologisk: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Aktiv komparator: 4
Tdap vaccine - normal saline - normal saline
Biologisk: rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Percentage of Participants With at Least One Adverse Event (AE)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alanine Aminotransferase [ALT])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Aspartate Aminotransferase [AST])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Protein)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Albumin)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Alkaline Phosphatase [ALP])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Total Bilirubin)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Creatine Phosphokinase [CPK])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Prothrombin Time [PT])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Partial Thromboplastin Time [PTT])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Fibrinogen)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Hemoglobin)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (White Blood Cell [WBC])
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Lymphocytes)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Neutrophils)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Eosinophils)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Platelet Count)
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Sodium).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Potassium).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Blood Urea Nitrogen [BUN]).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Serum Creatinine).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Red Blood Cells [RBC]).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Protein).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7
Percentage of Participants With Change in Severity From Baseline in Laboratory Evaluations (Urine Glucose).
Tidsramme: Baseline up to Month 7
Baseline up to Month 7

Sekundære resultatmål

Resultatmål
Tidsramme
Meningococcal Immunoglobulin G (IgG) Geometric Mean Titers (GMT)
Tidsramme: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3
Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3

Samarbejdspartnere og efterforskere

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

Sponsor

Pfizer

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.

Generelle publikationer

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

1. april 2009

Primær færdiggørelse (Faktiske)

1. juli 2012

Studieafslutning (Faktiske)

1. juli 2012

Datoer for studieregistrering

Først indsendt

10. april 2009

Først indsendt, der opfyldte QC-kriterier

10. april 2009

Først opslået (Skøn)

13. april 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

6. august 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. juli 2015

Sidst verificeret

1. juli 2015

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 6108A1-1004
  • B1971004 (Anden identifikator: Alias Study Number)

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 Meningitis, Meningokok

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Algeria

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner