MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

NCT04440163

Last updated date
Study Location
Complete Health Research
Ormond Beach, Florida, 32174, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Meningococcal Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
10-25 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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NCT04440163
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  6. Tempe, Arizona
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  23. Adairsville, Georgia
  24. Chamblee, Georgia
  25. Meridian, Idaho
  26. Nampa, Idaho
  27. Mishawaka, Indiana
  28. South Bend, Indiana
  29. Ankeny, Iowa
  30. West Des Moines, Iowa
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  33. Lexington, Kentucky
  34. Baton Rouge, Louisiana
  35. Haughton, Louisiana
  36. Saint Louis, Missouri
  37. Elkhorn, Nebraska
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Advanced Information
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
  • Biological: MenABCWY
    N meningitidis groups A, B, C, W, and Y vaccine
  • Biological: Saline
    Placebo
  • Biological: Trumenba
    Bivalent recombinant lipoprotein 2086 vaccine
  • Biological: MenACWY-CRM
    Meningococcal group A, C, W-135, and Y conjugate vaccine
Study Arms  ICMJE
  • Experimental: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
    ACWY Naive subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
    ACWY Naive subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
    ACWY Experienced subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
    ACWY Experienced subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
    ACWY Naive subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
    ACWY Naive subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
  • Experimental: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
    ACWY Experienced subjects, MenABCWY/Saline
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
  • Experimental: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
    ACWY Experienced subjects, Trumenba/MenACWY-CRM
    Interventions:
    • Biological: Trumenba
    • Biological: MenACWY-CRM
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
 (submitted: June 18, 2020)
2413
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 3, 2022
Estimated Primary Completion Date June 3, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 10 Years to 25 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP