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A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-25 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Male or female subject aged >=18 and

2. Healthy subject as determined by medical history, physical examination, and judgment
of the investigator.

3. Negative urine pregnancy test for all female subjects.

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

2. Subjects who are scheduled to receive 1 or more doses of an HPV vaccine as part of a
3-dose series during the period between Visit 1 and 28 days after the second
vaccination.

3. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.

4. 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.

5. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).

6. Current chronic use of systemic antibiotics.

7. Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.

8. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.

NCT01352845
Pfizer
Completed
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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