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
NCT01830855
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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.
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.
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Descriptive Information | ||||
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Brief Title ICMJE | 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 | |||
Official Title ICMJE | 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 | |||
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 study will also look at the safety of the new vaccine as well as how it is tolerated. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Prevention | |||
Condition ICMJE | Meningococcal Vaccine | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 3596 | |||
Original Estimated Enrollment ICMJE | 3600 | |||
Actual Study Completion Date ICMJE | April 2015 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 10 Years to 18 Years (Child, Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Canada, Czech Republic, Finland, Germany, Italy, Poland, United Kingdom, United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01830855 | |||
Other Study ID Numbers ICMJE | B1971009 6108A1-3001 ( Other Identifier: Alias Study Number ) 2010-023873-20 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | May 2016 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |