Miami Research Associates, Inc.
South Miami, Florida, 33143, United States
NCT Number: NCT00879814
The purpose of this study is to evaluate the safety and tolerability of an investigational meningococcal B rLP2086 vaccine in healthy adults.
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Notify Me18 year–40 year
All sexes
Interventional
Phase 1
South Miami, Florida, 33143, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A subject must meet the following inclusion criteria at screening (visit 1) and at randomization (visit 2) to be considered for enrollment in the study:
In addition a subject must meet the following inclusion criteria at randomization (visit 2) to be considered for enrollment in the study. The referred blood and urinalysis tests (inclusion criterion 5) will be performed on a blood and urine sample taken at visit 1:
Exclusion criteria
None
intra-muscular vaccine (solution), 0.5 mL, 3 doses, schedule: 0, 2, 6 months
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Baseline up to Month 7
Time frame: Before Dose 1, 1 month after Dose 2, before Dose 3, 1 month after Dose 3
Pfizer
Industry
A Phase 1 Randomized, Open-label, Parallel-group, Active- And Placebo-controlled Study To Assess Safety And Tolerability Of 60, 120, And 200 Mcg Meningococcal Group B Rlp2086 Vaccine In Healthy Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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