A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
NCT ID: NCT04440176
Last Updated: 2025-01-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
309 participants
INTERVENTIONAL
2020-06-17
2024-01-05
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Group 1 (MenABCWY 0-, 12-months)
MenABCWY administered at Month 0 and Month 12
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Group 2 (MenABCWY 0-, 36-months)
MenABCWY administered at Month 0 and Month 36
MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
Interventions
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MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Saline
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who have never received a prior dose of any meningococcal vaccine. Written confirmation of vaccination history must be obtained prior to randomization.
* Available for the entire study period and can be reached by telephone.
* Healthy participant as determined by medical history, physical examination, and judgement of the investigator.
* Negative urine pregnancy test for all female participants; pregnancy test is not applicable to male participants.
Exclusion Criteria
* Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
* A known or suspected defect of the immune system that would prevent an immune response to the vaccine, such as participants with congenital or acquired defects in B-cell function, those receiving chronic systemic (oral, intravenous, or intramuscular) corticosteroid therapy, or those receiving immunosuppressive therapy.
* History of microbiologically proven disease caused by Neisseria meningitidis or Neisseria gonorrhoeae.
* Significant neurological disorder or history of seizure (excluding simple febrile seizure).
* Any neuroinflammatory or autoimmune condition, including, but no limited to, transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
* Participants receiving any allergen immunotherapy with a nonlicensed product or receiving allergen immunotherapy with a licensed product and are not on stable maintenance doses.
* Receipt of any blood products, including immunoglobulin, within 6 months before the first study vaccination.
* Current use of systemic antibiotics with no foreseeable date of discontinuation prior to anticipated date of enrollment (first vaccination).
11 Years
14 Years
ALL
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States
California Research Foundation
San Diego, California, United States
Nona Pediatric Center
Orlando, Florida, United States
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Ohio Pediatric Research Association Inc.
Dayton, Ohio, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Benchmark Research
Fort Worth, Texas, United States
Texas Health Resources
Fort Worth, Texas, United States
Diagnostics Research Group
San Antonio, Texas, United States
Wee Care Pediatrics
Kaysville, Utah, United States
Wasatch Pediatrics, Cottonwood Office
Murray, Utah, United States
Utah Valley Pediatrics - Timpanogos Office
Orem, Utah, United States
Alliance for Multispecialty Research, LLC
Roy, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Alliance for Multispecialty Research, LLC
South Jordan, Utah, United States
Wee Care Pediatrics
Syracuse, Utah, United States
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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2019-004923-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C3511004
Identifier Type: -
Identifier Source: org_study_id
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