Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults (MenOccy)

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT00962624
First received: August 19, 2009
Last updated: March 27, 2012
Last verified: March 2012

August 19, 2009
March 27, 2012
July 2010
March 2011   (final data collection date for primary outcome measure)
Proportion of subjects attaining putative protective antibody concentrations against meningococci in the serum bactericidal antibody assay [ Time Frame: one month following the last vaccination ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00962624 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of Meningococcal B Vaccine and ACWY Conjugate Vaccine in Healthy Adults
A Phase 2, Open-label Study of the Safety, Tolerability and Immunogenicity of a Meningococcal B Vaccine When Administered at a 0, 2, 6 Months and of a Single Dose of Meningococcal ACWY Conjugate Vaccine in Healthy Adults Aged 18-65 Years

The study involves the measurement of immune response to vaccination with three doses of a meningococcal B vaccine and a single dose of a meningococcal ACYW conjugate vaccine in healthy adults (Laboratory workers). The study will be completed at the Manchester Medical Microbiology Partnership in the UK and will enrol staff who may be at potential occupational exposure to meningococci. Blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.

Laboratory staff at the Manchester Medical Microbiology Partnership may be at potential occupational exposure to meningococci. No licensed vaccine is available against serogroup B meningococci and the available plain polysaccharide serogroup ACYW vaccine is poorly immunogenic. Novartis Vaccines have developed an investigational serogroup B vaccine and a conjugated ACYW vaccine. This study will investigate these vaccines ability to induce a protective response in laboratory staff from the Manchester Medical Microbiology Partnership. Three doses of the meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. Blood samples will be taken before and after each vaccination and functional antibodies determined.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Meningococcal Meningitis, Serogroup A
  • Meningococcal Meningitis, Serogroup B
  • Meningococcal Meningitis, Serogroup C
  • Meningococcal Meningitis, Serogroup Y
  • Meningococcal Meningitis, Serogroup W
Drug: meningococcal B vaccine & meningococcal ACYW conjugate vaccine
Meningococcal B vaccine will be administered at 0, 2 and 6 months and a single dose of meningococcal ACYW vaccine will be administered at 0 months, concomitantly with the first dose of the meningococcal B vaccine.
Other Name: Meningococcal ACYW vaccine- MenVeo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
38
March 2012
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Aged 18-65 years of age
  • Who have given written informed consent after the nature of the study has been explained.
  • Who work within the Manchester Medical Microbiology Partnership and may be at potential occupational exposure to meningococci.

Exclusion Criteria:

  • The possibility of pregnancy
  • A serious chronic disease including progressive neurological disease or seizure disorder.
  • Have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  • Have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component.
  • Have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00962624
MenOccy, I72P1
No
Dr. Elizabeth Miller, Health Protection Agency, United Kingdom
Dr. Elizabeth Miller
Novartis Vaccines
Principal Investigator: Ray Borrow, PhD Health Protection Agency, United Kingdom
Health Protection Agency, United Kingdom
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP