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.
Status: | Recruiting |
---|---|
Conditions: | Vaccines |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 10 - 25 |
Updated: | 9/9/2018 |
Start Date: | April 24, 2017 |
End Date: | January 18, 2023 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
A Phase 3, Randomized, Active-controlled, Observer-blinded Study To Assess The Immunogenicity, Safety, And Tolerability Of Bivalent Rlp2086 When Administered As A 2-dose Regimen And A First-in-human Study To Describe The Immunogenicity, Safety, And Tolerability Of A Bivalent Rlp2086-Containing Pentavalent Vaccine (Menabcwy) In Healthy Subjects>=10 To <26 Years Of Age
This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a
0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal
pentavalent vaccine.
0-,6- month schedule. This trial is also studyng safety and immunogenicity of a meningococcal
pentavalent vaccine.
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 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.
We found this trial at
53
sites
Site Overview Avail Clinical Research is a renowned and experienced clinical research site conducting Phase...
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52 Medical Plaza Drive
Birmingham, Alabama 35205
Birmingham, Alabama 35205
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Lynn Health Science Institute Our mission is to provide clinical trials research and health services...
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