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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00780806
First received: October 24, 2008
Last updated: August 22, 2011
Last verified: August 2011

October 24, 2008
August 22, 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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00780806 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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
Interventions:
  • Biological: meningococcal B rLP2086 vaccine candidate
  • Procedure: Blood draw
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
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.
Both
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Australia
 
NCT00780806
6108A1-1003, B1971003
Yes
Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Pfizer CT.gov 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