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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.

Last updated on February 22, 2019

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Study Location
Alabama Clinical Therapeutics, LLC / Birmingham Pediatric Associates
Birmingham, Alabama, 35205 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-25 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female subject aged >=10 and

- 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

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Previous vaccination with any meningococcal serogroup B or purely polysaccaride
(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.

NCT03135834
Pfizer
Recruiting
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.

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