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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.

NCT03135834

CompletedPhase 3

Sponsor: Pfizer

Conditions: Meningococcal Vaccine

Interventions: MenABCWY, Saline, rLP2086, MenACWY-CRM

Countries: United States, Czechia, Finland, Poland

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.

Eligibility overview

Sex: ALL

Age: 10 Years to 25 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Locations (75)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
Fountain Hills, Arizona, United States
Tempe, Arizona, United States
Harrisburg, Arkansas, United States
La Mesa, California, United States
San Diego, California, United States
Santa Clara, California, United States
DeLand, Florida, United States
Jupiter, Florida, United States
Melbourne, Florida, United States
Savannah, Georgia, United States
Peoria, Illinois, United States
Sioux City, Iowa, United States
Newton, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Wichita, Kansas, United States
Bardstown, Kentucky, United States
Eunice, Louisiana, United States
Haughton, Louisiana, United States
Fremont, Nebraska, United States
Norfolk, Nebraska, United States
Omaha, Nebraska, United States
Binghamton, New York, United States
Binghamton, New York, United States
Binghamton, New York, United States
Binghamton, New York, United States
Endwell, New York, United States
+ 45 more on CT.gov