A Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules

NCT04440176

Last updated date
Study Location
California Research Foundation
San Diego, California, 92123-1881, 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
11-14 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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


- 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).

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 Trial to Describe the Safety and Immunogenicity of MenABCWY When Administered on 2 Schedules
NCT04440176
  1. San Diego, California
  2. Raleigh, North Carolina
  3. Mount Pleasant, South Carolina
  4. Fort Worth, Texas
  5. Fort Worth, Texas
  6. Kaysville, Utah
  7. Murray, Utah
  8. Orem, Utah
  9. Roy, Utah
  10. Salt Lake City, Utah
  11. Salt Lake City, Utah
  12. South Jordan, Utah
  13. Charlottesville, Virginia
  14. Charlottesville, Virginia
  15. Charlottesville, Virginia
ALL GENDERS
11 Years+
years
MULTIPLE SITES
Meningococcal VaccineMenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age
NCT04440163
  1. Banning, California
  2. Coral Gables, Florida
  3. Chamblee, Georgia
  4. Meridian, Idaho
  5. Nampa, Idaho
  6. Newton, Kansas
  7. Lexington, Kentucky
  8. Nicholasville, Kentucky
  9. Baton Rouge, Louisiana
  10. Saint Louis, Missouri
  11. Bellevue, Nebraska
  12. Binghamton, New York
  13. Salisbury, North Carolina
  14. Wilmington, North Carolina
  15. Wilmington, North Carolina
  16. Winston-Salem, North Carolina
  17. Cleveland, Ohio
  18. Norman, Oklahoma
  19. Charleston, South Carolina
  20. Bristol, Tennessee
  21. Bristol, Tennessee
  22. South Jordan, Utah
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
Meningococcal VaccineA Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
NCT03135834
  1. Fremont, Nebraska
  2. Birmingham, Alabama
  3. Huntsville, Alabama
  4. Fountain Hills, Arizona
  5. Tempe, Arizona
  6. Harrisburg, Arkansas
  7. La Mesa, California
  8. San Diego, California
  9. Santa Clara, California
  10. DeLand, Florida
  11. Jupiter, Florida
  12. Melbourne, Florida
  13. Savannah, Georgia
  14. Peoria, Illinois
  15. Newton, Kansas
  16. Newton, Kansas
  17. Wichita, Kansas
  18. Wichita, Kansas
  19. Bardstown, Kentucky
  20. Eunice, Louisiana
  21. Haughton, Louisiana
  22. Norfolk, Nebraska
  23. Omaha, Nebraska
  24. Binghamton, New York
  25. Endwell, New York
  26. Rochester, New York
  27. Raleigh, North Carolina
  28. Cincinnati, Ohio
  29. Cleveland, Ohio
  30. Columbus, Ohio
  31. Dayton, Ohio
  32. Oklahoma City, Oklahoma
  33. Erie, Pennsylvania
  34. Mount Pleasant, South Carolina
  35. Mount Pleasant, South Carolina
  36. Dakota Dunes, South Dakota
  37. Bristol, Tennessee
  38. Bristol, Tennessee
  39. Kingsport, Tennessee
  40. Nashville, Tennessee
  41. Austin, Texas
  42. Fort Worth, Texas
  43. Fort Worth, Texas
  44. Fort Worth, Texas
  45. Fort Worth, Texas
  46. Plano, Texas
  47. San Antonio, Texas
  48. Draper, Utah
  49. Salt Lake City, Utah
  50. Salt Lake City, Utah
  51. South Jordan, Utah
  52. Burke, Virginia
  53. Charlottesville, Virginia
  54. Jindrichuv Hradec,
  55. Praha 6,
  56. Espoo,
  57. Helsinki,
  58. Helsinki,
  59. Järvenpää,
  60. Kokkola,
  61. Oulu,
  62. Pori,
  63. Seinajoki,
  64. Tampere,
  65. Turku,
  66. Debica,
  67. Krakow,
  68. Krakow,
ALL GENDERS
10 Years+
years
MULTIPLE SITES
Advanced Information
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
  • Biological: MenABCWY
    Neisseria meningitidis group A, B, C, W, and Y vaccine
    Other Name: pentavalent meningococcal vaccine
  • Biological: Saline
    Placebo
Study Arms  ICMJE
  • Experimental: Group 1 (MenABCWY 0-, 24-months)
    MenABCWY administered at Month 0 and Month 24
    Intervention: Biological: MenABCWY
  • Experimental: Group 2 (MenABCWY 0-, 48-months)
    MenABCWY administered at Month 0 and Month 48
    Interventions:
    • Biological: MenABCWY
    • Biological: Saline
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 18, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 19, 2026
Estimated Primary Completion Date April 19, 2026   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 Criteria:

  • 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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 11 Years to 14 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
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 June 2020

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