Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00780806
Recruitment Status : Completed
First Posted : October 28, 2008
Last Update Posted : August 23, 2011
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer

October 24, 2008
October 28, 2008
August 23, 2011
October 2008
May 2010   (Final data collection date for primary outcome measure)
Safety of 3 doses of MnB rLP2086 vaccine candidate assessed by frequency of solicited local and systemic reactions collected for 7 days after each study vaccination; evaluation of occurrence of AE and SAE during the duration of study [ Time Frame: Up to 2 years ]
Same as current
Complete list of historical versions of study NCT00780806 on Archive Site
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Safety And Blood Collection Study Of Meningococcal B Rlp2086 Vaccine In Adults
An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
The purpose of this study is to evaluate the safety of an investigational meningococcal B rLP2086 vaccine in adults and to obtain blood samples from immunized subjects for use in assay development.
Not Provided
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Meningitis, Meningococcal
  • Biological: meningococcal B rLP2086 vaccine candidate
    vaccine, 0.5 mL, 3 doses, 0 - 2 - 6 to 9 months
  • Procedure: Blood draw
    Blood draw
Experimental: 1
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
  • Biological: meningococcal B rLP2086 vaccine candidate
  • Procedure: Blood draw
Marshall HS, Richmond PC, Nissen MD, Wouters A, Baber J, Jiang Q, Anderson AS, Jones TR, Harris SL, Jansen KU, Perez JL. A phase 2 open-label safety and immunogenicity study of a meningococcal B bivalent rLP2086 vaccine in healthy adults. Vaccine. 2013 Mar 15;31(12):1569-75. doi: 10.1016/j.vaccine.2013.01.021. Epub 2013 Jan 24.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2010
May 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy male or female subject between the ages of >=18 and <=40 years
  • Negative urine pregnancy test for all female subjects of childbearing potential prior to test article administration and at the completion of the study.
  • All female or male subjects who are biologically capable of having children must agree to abstinence or commit to the use of a reliable method of birth control during for the duration of the study and for 30 days after early discontinuation. 4. Hemoglobin levels >=12.0 and <=16.5 g/dL for female subjects and >=13.0 and <=18.5 g/dL for male subjects.
  • Blood pressure: Systolic blood pressure >90 and <160 mm Hg; Diastolic blood pressure >60 and <95 mm Hg.
  • Body weight >=45 and <=120 kg.
  • Able to be contacted by telephone during the study period.

Exclusion Criteria:

  • Pregnancy or breastfeeding women
  • Prior vaccination with a serogroup B meningococcal vaccine.
  • A previous anaphylactic or severe vaccine-associated adverse reaction.
  • A known hypersensitivity to any study vaccine components.
  • A known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids (excluding topical, inhalation and intra-articular corticosteroids).
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Receipt of any blood products, including gamma globulin, in the period from 6 months before study vaccination through the study conclusion.
  • Receipt of an inactivated vaccine within 14 days before study vaccinations and live attenuated vaccine within 28 days before study vaccination. This will apply throughout the study until the last vaccination.
  • Any clinically significant chronic disease that, in the investigator's judgment may be worsened by blood draw.
  • Received any investigational drug, vaccine or device within the 30-day period before study visit 1 and during the conduct of the study.
  • History of culture-proven invasive disease caused by N meningitidis or N gonorrhoea.
Sexes Eligible for Study: All
18 Years to 40 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
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Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer Call Center Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
August 2011

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