Study Evaluating Safety And Tolerability Of Meningococcal B Rlp2086 Vaccine In Healthy Adults
NCT ID: NCT00879814
Last Updated: 2015-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2009-04-30
2012-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
rLP2086 vaccine 60 mcg
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
2
rLP2086 vaccine 120 mcg
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
3
rLP2086 vaccine 200 mcg
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
4
Tdap vaccine - normal saline - normal saline
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Interventions
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rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
rLP2086 vaccine or control
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Eligibility Criteria
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Inclusion Criteria
* Healthy male or female subjects as determined by medical history, physical examination, and judgment of the investigator.
* Male or female subject who is considered biologically capable of having children must agree to commit to the use of a reliable method of birth control for the duration of the study and for 30 days after early discontinuation. A subject is still biologically capable of having children, even if he or she is using contraceptives or if his or her sexual partner is sterile or using contraceptives.
* Female subjects of childbearing potential with a negative urine pregnancy test prior to study drug administration. Note: this criterion will apply to each vaccination visit and to the last study visit.
* Laboratory blood and urinalysis tests results within the per-protocol normal ranges.
* Able to be contacted by telephone during the study period. Note: this criterion will apply to each study visit.
Exclusion Criteria
18 Years
40 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Miami Research Associates, Inc.
South Miami, Florida, United States
Countries
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References
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Beeslaar J, Mather S, Absalon J, Eiden JJ, York LJ, Crowther G, Maansson R, Maguire JD, Peyrani P, Perez JL. Safety data from the MenB-FHbp clinical development program in healthy individuals aged 10 years and older. Vaccine. 2022 Mar 15;40(12):1872-1878. doi: 10.1016/j.vaccine.2022.01.046. Epub 2022 Feb 11.
Sheldon EA, Schwartz H, Jiang Q, Giardina PC, Perez JL. A phase 1, randomized, open-label, active-controlled trial to assess the safety of a meningococcal serogroup B bivalent rLP2086 vaccine in healthy adults. Hum Vaccin Immunother. 2012 Jul;8(7):888-95. doi: 10.4161/hv.19983. Epub 2012 Jul 1.
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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B1971004
Identifier Type: OTHER
Identifier Source: secondary_id
6108A1-1004
Identifier Type: -
Identifier Source: org_study_id
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