Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT00197795
NCT00197795CompletedPhase 2

Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults

Public Health England0 sites30 target enrollmentStarted: January 1, 2005Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
30
Study OverviewStudy DesignEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To measure the serum bactericidal antibody levels and cell mediated immune responses before and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6 and 12 weeks to healthy UK adults.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •Informed written consent given for three immunizations with MenBVac and five blood tests
  • •Between the ages of 18 and 55 years inclusive at recruitment

Exclusion Criteria

  • •Previous history of bacteriologically confirmed meningococcal disease
  • •History of clinically significant allergic sensitivity to any vaccine received in the past
  • •Immunodeficiency
  • •Any other acute or chronic systemic illness or dependence or abuse of drugs or alcohol
  • •Language difficulties sufficient to preclude adequate comprehension of the study information
  • •Possibility of pregnancy
  • •Receipt of any other vaccine in the previous 4 weeks
  • •Receipt of any group B vaccine in the past
  • •Current participation in any other clinical trial
  • •Generalized acute systemic illness and/or temp >38C on day of vaccination deferral

Investigators

Sponsor Class
Other Gov
Responsible Party
Principal Investigator
Principal Investigator

Prof. Elizabeth Miller

Consultant epidemiologist

Public Health England

Similar Trials

Completed
Phase 3
Immunogenicity and Safety Study of a Quadrivalent Meningococcal Conjugate Vaccine When Co-administered With Routine Pediatric Vaccines in Healthy Infants and Toddlers in EuropeMeningococcal Infections
NCT03547271Sanofi Pasteur, a Sanofi Company1,660
Completed
Phase 3
Immunogenicity and Safety of Meningococcal (A, C, Y and W135) Conjugate VaccineMeningitis
NCT02003495Beijing Minhai Biotechnology Co., Ltd2,195
Completed
Phase 2
Study to Assess Potential Immune Interference When GlaxoSmithKline (GSK) Biologicals' MenABCWY Vaccine is Administered to Healthy Subjects Aged 10-25 YearsMeningitis, Meningococcal
NCT03587207GlaxoSmithKline520
Completed
Phase 3
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Meningococcal Conjugate Vaccine (GSK134612) When Co-administered With Boostrix® in Subjects Between 11 and 25 Years of AgeInfections, Meningococcal
NCT01767376GlaxoSmithKline692
Completed
Phase 2
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®PertussisTetanusDiphtheriaMeningococcal MeningitisPoliomyelitis
NCT00355121Sanofi882