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
Status: | Completed |
---|---|
Conditions: | Vaccines, Infectious Disease, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 10 - 18 |
Updated: | 7/11/2015 |
Start Date: | April 2013 |
End Date: | April 2015 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 3, Randomized, Active-controlled, Observer-blinded Trial To Assess The Lot Consistency, Safety, Tolerability, And Immunogenicity Of A Meningococcal Serogroup B Bivalent Rlp2086 Vaccine In Healthy Subjects Aged >/=10 To <19 Years
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 study will also look at the safety of the new vaccine as well as how it is
tolerated.
study whether healthy adolescent subjects receiving different lots of vaccine respond in a
similar way. The study will also look at the safety of the new vaccine as well as how it is
tolerated.
Inclusion Criteria:
1. Male or female subject aged >=10 and <19 years at the time of enrollment.
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:
1. Previous vaccination with any meningococcal serogroup B vaccine.
2. Subjects who have received prior HAV vaccination.
3. 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.
4. Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
allergen immunotherapy with a licensed product and are not on stable maintenance
doses.
5. 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.
6. Significant neurological disorder or history of seizure (excluding simple febrile
seizure).
7. Current chronic use of systemic antibiotics.
8. Received any investigational vaccines, drugs, or devices within 28 days before
administration of the first study vaccination.
9. Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
We found this trial at
65
sites
Creighton University Medical Center St. Joseph's Mercy Hospital was founded on September 25, 1870 at...
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