MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
NCT04440163
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
Adult Trials: 18+ Years
- Male or female subject aged >=10 and <26 years at the time of randomization.
- Healthy subject as determined by medical history, physical examination, and judgment of the investigator.
- Negative urine pregnancy test for all female subjects.
- ACWY-naïve participants: Participants who have never received a prior dose of a meningococcal vaccine containing ACWY serogroups.
- ACWY-experienced participants: Participants who have received not more than 1 prior dose, no sooner than 4 years prior to the date of randomization of Menactra or Menveo.
- Previous vaccination with any meningococcal group B vaccine, any purely polysaccharide
(nonconjugate) meningococcal vaccine, or monovalent/bivalent meningococcal vaccine.-
Subjects receiving any allergen immunotherapy with a non-licensed 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.
- Participation in other studies involving investigational drug(s) or investigational
vaccine(s) within 28 days prior to study entry and/or during study participation.
- Any neuroinflammatory or autoimmune condition, including, but not limited to,
transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
- History of microbiologically proven disease caused by N meningitidis or Neisseria
gonorrhoeae.
- Receipt of any blood products, including immunoglobulin, within 6 months before the
first study vaccination.
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | MenABCWY Noninferiority Study in Healthy Participants ?10 to <26 Years of Age | ||||||
| Official Title ICMJE | A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, OBSERVER-BLINDED TRIAL TO ASSESS THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY IN HEALTHY PARTICIPANTS ?10 TO <26 YEARS OF AGE | ||||||
| Brief Summary | The aim of this study is to determine the immunologic noninferiority of MenABCWY to licensed vaccines Trumenba and MenACWY-CRM (Menveo) by assessing the safety and immunogenicity of MenABCWY and the comparators in both ACWY-naïve and ACWY-experienced healthy participants ?10 to <26 years of age. | ||||||
| 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 * | Not Provided | ||||||
* 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 | Recruiting | ||||||
| Estimated Enrollment ICMJE | 2413 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | April 19, 2022 | ||||||
| Estimated Primary Completion Date | April 19, 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
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| Ages ICMJE | 10 Years to 25 Years (Child, Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | Czechia, Denmark, Hungary, Poland, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04440163 | ||||||
| Other Study ID Numbers ICMJE | C3511001 2019-004313-13 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | February 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||