Status:
COMPLETED
A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
Lead Sponsor:
Pfizer
Conditions:
Meningococcal Vaccine
Eligibility:
All Genders
11-14 years
Phase:
PHASE2
Brief Summary
This study is designed to describe the short-term immunogenicity and safety of 2 doses of Neisseria meningitidis group A, B, C, W, and Y vaccine (MenABCWY) separated by either 12 or 36 months during a...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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).
Key Trial Info
Start Date :
June 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 5 2024
Estimated Enrollment :
309 Patients enrolled
Trial Details
Trial ID
NCT04440176
Start Date
June 17 2020
End Date
January 5 2024
Last Update
January 8 2025
Active Locations (20)
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1
Alliance for Multispecialty Research, LLC
Mobile, Alabama, United States, 36608
2
California Research Foundation
San Diego, California, United States, 92123
3
Nona Pediatric Center
Orlando, Florida, United States, 32829
4
Velocity Clinical Research, Norfolk
Norfolk, Nebraska, United States, 68701