NCT00780806CompletedPhase 1
An Open-Label Safety And Blood Collection Study In Mnb Rlp2086 Vaccinated Healthy Adult Volunteers For Immunological Assay Development
Wyeth is now a wholly owned subsidiary of Pfizer3 sites in 1 country60 target enrollmentStarted: October 1, 2008Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- 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
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
- •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.
Arms & Interventions
1
Experimental
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
Intervention: meningococcal B rLP2086 vaccine candidate (Biological)
1
Experimental
Immunization with one dose of MnB rLP2086 vaccine at 0, 1 and 6 months
Intervention: Blood draw (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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