A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
NCT04440176
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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Adult Trials: 18+ Years
- Male or female participants 11 through <15 years of age at the time of randomization.
- 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.
- A previous anaphylactic reaction to any vaccine or vaccine-related component.
- 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).
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules | ||||||
| Official Title ICMJE | A PHASE 2b, RANDOMIZED, OBSERVER-BLINDED TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MenABCWY ADMINISTERED ON 2 DIFFERENT DOSING SCHEDULES IN HEALTHY PARTICIPANTS ?11 TO <15 YEARS OF AGE | ||||||
| Brief Summary | This study is designed to describe the short-term immunogenicity, persistence of bactericidal responses, and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 2 or 4 years during adolescence. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| 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 | 300 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 17, 2024 | ||||||
| Estimated Primary Completion Date | March 17, 2024 (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 | 11 Years to 14 Years (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04440176 | ||||||
| Other Study ID Numbers ICMJE | C3511004 2019-004923-19 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| 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 |
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| PRS Account | Pfizer | ||||||
| Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||