A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Completed · Phase 3 · Has a placebo group
Conditions studied: Meningococcal Vaccine
In brief
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a 0-,6- month schedule. This trial is also studying safety and immunogenicity of a meningococcal pentavalent vaccine.
Key facts
- Study ID
- NCT03135834
- Run by
- Pfizer
- People needed
- 1610
- Starts
- 2017-04-24
- Expected to finish
- 2022-10-25
- Last updated by the study team
- 2023-08-08
Who can join
Age: 10 and older, up to 25. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Male or female subject aged >=10 and <26 years at the time of enrollment.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
- Subjects who have not received, or who have received no more than 1 prior dose within the past 4 years, of a vaccine containing 1 or more ACWY serogroup
You may not qualify if…
- Previous vaccination with any meningococcal serogroup B or purely polysaccharide (nonconjugate) meningococcal vaccine.
- Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
- A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as subjects with congenital or acquired defects in B cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the United States with terminal complement deficiency are excluded from participation in this study.
- Significant neurological disorder or history of seizure (excluding simple febrile seizure).
- Current chronic use of systemic antibiotics.
- Received any investigational vaccines, drugs, or devices within 28 days before administration of the first study vaccination.
- Any neuroinflammatory or autoimmune condition, including, but not limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
Where it is running
- Optimal Research, LLC — Huntsville, Alabama, United States
- Synexus Clinical Research US, Inc./Fountain Hills Family Practice, P.C. — Fountain Hills, Arizona, United States
- Clinical Research Consortium — Tempe, Arizona, United States
- Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
- Paradigm Clinical Research Centers, Inc. — La Mesa, California, United States
- California Research Foundation — San Diego, California, United States
- Kaiser Permanente Santa Clara — Santa Clara, California, United States
- Avail Clinical Research, LLC — DeLand, Florida, United States
- Health Awareness, Inc. — Jupiter, Florida, United States
- Optimal Research, LLC — Melbourne, Florida, United States
- Meridian Clinical Research LLC — Savannah, Georgia, United States
- Optimal Research — Peoria, Illinois, United States
- Meridian Clinical Research — Sioux City, Iowa, United States
- Alliance for Multispecialty Research, LLC — Newton, Kansas, United States
- Heartland Research Associates, LLC — Wichita, Kansas, United States
- Alliance For Multispecialty Research (AMR) — Wichita, Kansas, United States
- Alliance for Multispecialty Research, LLC — Wichita, Kansas, United States
- Heartland Research Associates, LLC — Wichita, Kansas, United States
- Kentucky Pediatric/Adult Research — Bardstown, Kentucky, United States
- Horizon Research Group of Opelousas, LLC — Eunice, Louisiana, United States
- ACC Pediatric Research — Haughton, Louisiana, United States
- Methodist Physicians Clinic/CCT Research — Fremont, Nebraska, United States
- Meridian Clinical Research, LLC — Norfolk, Nebraska, United States
- Meridian Clinical Research, LLC — Omaha, Nebraska, United States
- Alabama Clinical Therapeutics, LLC — Birmingham, Alabama, United States
Full record on ClinicalTrials.gov
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