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

NCT04440163

Last updated date
Study Location
J. Lewis Research, Inc. / Foothill Family Clinic
Salt Lake City, Utah, 84109, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

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.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Meningococcal VaccineA Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of MenABCWY in Healthy Infants
NCT04645966
  1. Santiago de Compostela, A Coruna
  2. Paiporta, Valencia
  3. Madrid,
  4. Madrid,
  5. Valencia,
  6. Valencia,
  7. Valencia,
  8. Valencia,
ALL GENDERS
60 Days+
years
MULTIPLE SITES
Meningococcal VaccineA Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
NCT04440176
  1. Cincinnati, Ohio
  2. Cincinnati, Ohio
  3. Mobile, Alabama
  4. San Diego, California
  5. Orlando, Florida
  6. Atlanta, Georgia
  7. Norfolk, Nebraska
  8. Raleigh, North Carolina
  9. Dayton, Ohio
  10. Mount Pleasant, South Carolina
  11. Fort Worth, Texas
  12. Fort Worth, Texas
  13. San Antonio, Texas
  14. Kaysville, Utah
  15. Murray, Utah
  16. Orem, Utah
  17. Roy, Utah
  18. Salt Lake City, Utah
  19. Salt Lake City, Utah
  20. South Jordan, Utah
  21. Syracuse, Utah
  22. Charlottesville, Virginia
ALL GENDERS
11 Years+
years
MULTIPLE SITES
Meningococcal VaccineMenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
NCT04440163
  1. Salt Lake City, Utah
  2. Salt Lake City, Utah
  3. Birmingham, Alabama
  4. Birmingham, Alabama
  5. Tempe, Arizona
  6. Banning, California
  7. Madera, California
  8. Paramount, California
  9. Paramount, California
  10. Colorado Springs, Colorado
  11. Coral Gables, Florida
  12. Hollywood, Florida
  13. Jupiter, Florida
  14. Lake Worth, Florida
  15. Miami Lakes, Florida
  16. Miami, Florida
  17. Miami, Florida
  18. Miami, Florida
  19. Ormond Beach, Florida
  20. Tampa, Florida
  21. Adairsville, Georgia
  22. Chamblee, Georgia
  23. Meridian, Idaho
  24. Nampa, Idaho
  25. Mishawaka, Indiana
  26. South Bend, Indiana
  27. Ankeny, Iowa
  28. West Des Moines, Iowa
  29. El Dorado, Kansas
  30. Newton, Kansas
  31. Lexington, Kentucky
  32. Baton Rouge, Louisiana
  33. Haughton, Louisiana
  34. Saint Louis, Missouri
  35. Elkhorn, Nebraska
  36. Omaha, Nebraska
  37. Binghamton, New York
  38. Salisbury, North Carolina
  39. Wilmington, North Carolina
  40. Winston-Salem, North Carolina
  41. Cleveland, Ohio
  42. Cleveland, Ohio
  43. Dayton, Ohio
  44. Fairfield, Ohio
  45. Norman, Oklahoma
  46. Yukon, Oklahoma
  47. Erie, Pennsylvania
  48. Philadelphia, Pennsylvania
  49. Charleston, South Carolina
  50. Greenville, South Carolina
  51. Bristol, Tennessee
  52. Bristol, Tennessee
  53. Chattanooga, Tennessee
  54. Kingsport, Tennessee
  55. Carrollton, Texas
  56. Plano, Texas
  57. Plano, Texas
  58. San Antonio, Texas
  59. Holladay, Utah
  60. Provo, Utah
  61. South Jordan, Utah
  62. Hradec Kralove, Hradec Králové
  63. Ceske Budejovice,
  64. Jindrichuv Hradec,
  65. Pardubice,
  66. Praha 6,
  67. Pribram,
  68. Aarhus N,
  69. Balatonfüred,
  70. Debrecen,
  71. Gyula,
  72. Miskolc,
  73. Székesfehérvár,
  74. Debica,
  75. Krakow,
  76. Krakow,
  77. Leczna,
  78. Siemianowice Slaskie,
  79. Trzebnica,
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Meningococcal VaccineA Trial To Assess The Safety, Tolerability, And Immunogenicity Of Rlp2086 Vaccine When Administered In Either 2- Or 3-Dose Regimens In Healthy Subjects Aged ≥11 To <19 Years
NCT01299480
  1. Brandys nad Labem - Stara Boleslav,
  2. Chlumec nad Cidlinou,
  3. Holice,
  4. Hradec Kralove,
  5. Hradec Kralove,
  6. Hradec Kralove,
  7. Jindrichuv Hradec,
  8. Odolena Voda,
  9. Pardubice,
  10. Pardubice,
  11. Praha - Horni Pocernice,
  12. Praha - Nusle,
  13. Praha 1,
  14. Praha 6 - Petriny,
  15. Praha 6,
  16. Sezemice,
  17. Aarhus N,
  18. Helsinki,
  19. Helsinki,
  20. Helsinki,
  21. Järvenpää,
  22. Kokkola,
  23. Lahti,
  24. Oulu,
  25. Piispansilta 11,
  26. Pori,
  27. Seinäjoki,
  28. Tampere,
  29. Turku,
  30. Vantaa,
  31. Bad Saulgau,
  32. Bramsche,
  33. Kleve,
  34. Mainz,
  35. Neumuenster,
  36. Neumuenster,
  37. Neustadt/Aisch,
  38. Debica,
  39. Krakow,
  40. Krakow,
  41. Leczna,
  42. Lubartow,
  43. Lublin,
  44. Oborniki Slaskie,
  45. Poznan,
  46. Siemianowice Slaskie,
  47. Torun,
  48. Trzebnica,
  49. Sant Cugat Del Valles, Barcelona
  50. Sant Vicenç Del Horts, Barcelona
  51. Blanes, Girona
  52. Paiporta, Valencia
  53. Quart de Poblet, Valencia
  54. Almeria,
  55. Barcelona,
  56. Madrid,
  57. Valencia,
  58. Valencia,
  59. Valencia,
  60. Valencia,
  61. Eskilstuna,
  62. Malmo,
  63. Orebro,
ALL GENDERS
11 Years+
years
MULTIPLE SITES
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 April 19, 2022
Estimated Primary Completion Date April 19, 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 December 2020

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