Status:
COMPLETED
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
Lead Sponsor:
Pfizer
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
10-18 years
Phase:
PHASE3
Brief Summary
This study is looking at a new vaccine that might prevent meningococcal disease, and will study whether healthy adolescent subjects receiving different lots of vaccine respond in a similar way. The st...
Eligibility Criteria
Inclusion
- Male or female subject aged \>=10 and \<19 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.
Exclusion
- Previous vaccination with any meningococcal serogroup B vaccine.
- Subjects who have received prior HAV vaccination.
- 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.
- 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.
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2015
Estimated Enrollment :
3596 Patients enrolled
Trial Details
Trial ID
NCT01830855
Start Date
April 1 2013
End Date
April 1 2015
Last Update
June 14 2016
Active Locations (99)
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1
Birmingham Pediatric Associates, PC
Birmingham, Alabama, United States, 35205
2
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States, 35235
3
Southeastern Pediatrics
Dothan, Alabama, United States, 36305
4
Harrisburg Family Medical Center
Harrisburg, Arkansas, United States, 72432