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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440176
Recruitment Status : Active, not recruiting
First Posted : June 19, 2020
Last Update Posted : September 26, 2022
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Description
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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 adolescence, and immunopersistence up to 24 months after completing 2 doses separated by a 12-month interval.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine Biological: MenABCWY Biological: Saline Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : March 17, 2024
Estimated Study Completion Date : March 17, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group 1 (MenABCWY 0-, 12-months)
MenABCWY administered at Month 0 and Month 12
 Biological: MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Other Name: pentavalent meningococcal vaccine
Experimental: Group 2 (MenABCWY 0-, 36-months)
MenABCWY administered at Month 0 and Month 36
 Biological: MenABCWY
Neisseria meningitidis group A, B, C, W, and Y vaccine
Other Name: pentavalent meningococcal vaccine

Biological: Saline
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of participants achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains [ Time Frame: 1 month after second dose of MenABCWY in Group 1 ]
    Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 12-month schedule

  2. Percentage of participants achieving an hSBA titer >= LLOQ for 4 primary MenB test strains [ Time Frame: 1 month after second dose of MenABCWY in Group 2 ]
    Describe the immune response for MenB induced by 2 doses of MenABCWY administered on a 0- and 36-month schedule

  3. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the first MenABCWY vaccination [ Time Frame: within 30 days after first MenABCWY vaccination ]
    Describe frequency of AE, SAE, MAE, and NDCMC after first dose of MenABCWY

  4. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the second MenABCWY vaccination [ Time Frame: within 30 days after second MenABCWY vaccination ]
    Describe frequency of AE, SAE, MAE, and NDCMC after second dose of MenABCWY

  5. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after the placebo vaccination in Group 2 [ Time Frame: within 30 days after placebo vaccination in Group 2 ]
    Describe frequency of AE, SAE, MAE, and NDCMC after placebo vaccination in Group 2

  6. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 30 days after any MenABCWY vaccination [ Time Frame: within 30 days after any MenABCWY vaccination ]
    Describe frequency of AE, SAE, MAE, and NDCMC after any dose of MenABCWY

  7. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 vaccination phase [ Time Frame: from Vaccination 1 through 1 month after Vaccination 1 ]
    Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 1 vaccination phase

  8. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 vaccination phase [ Time Frame: from Vaccination 2 through 1 month after Vaccination 2 ]
    Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 2 vaccination phase

  9. Percentage of participants reporting at least 1 adverse event (AE), at least 1 serious AE (SAE), at least 1 medically attended AE (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 3 vaccination phase in Group 2 [ Time Frame: from Vaccination 3 through 1 month after Vaccination 3 in Group 2 ]
    Describe frequency of AE, SAE, MAE, and NDCMC during the Vaccination 3 vaccination phase in Group 2

  10. Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 1 follow-up phase [ Time Frame: from 1 month after Vaccination 1 through 6 months after Vaccination 1 ]
    Describe frequency of SAE, MAE, and NDCMC during the Vaccination 1 follow-up phase

  11. Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) during the Vaccination 2 follow-up phase [ Time Frame: from 1 month after Vaccination 2 through 6 months after Vaccination 2 ]
    Describe frequency of SAE, MAE, and NDCMC during the Vaccination 2 follow-up phase

  12. Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 1 [ Time Frame: from Vaccination 1 through 6 months after Vaccination 1 ]
    Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 1

  13. Percentage of participants reporting at least 1 serious adverse event (SAE), at least 1 medically attended adverse event (MAE), and at least 1 newly diagnosed medical condition (NDCMC) within 6 months after Vaccination 2 [ Time Frame: from Vaccination 2 through 6 months after Vaccination 2 ]
    Describe frequency of SAE, MAE, and NDCMC within 6 months after Vaccination 2

  14. Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 1 [ Time Frame: within 30 minutes after Vaccination 1 ]
    Describe the frequency of immediate AE after Vaccination 1

  15. Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 2 [ Time Frame: within 30 minutes after Vaccination 2 ]
    Describe the frequency of immediate AE after Vaccination 2

  16. Percentage of participants reporting at least 1 immediate adverse event (AE) after Vaccination 3 in Group 2 [ Time Frame: within 30 minutes after Vaccination 3 in Group 2 ]
    Describe the frequency of immediate AE after Vaccination 3 in Group 2

  17. Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 1 [ Time Frame: within 6 months after Vaccination 1 ]
    Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 1

  18. Percentage of participants reporting missed days of school or work due to adverse events within 6 months after Vaccination 2 [ Time Frame: within 6 months after Vaccination 2 ]
    Describe frequency of missed days of school or work due to AEs within 6 months after Vaccination 2

  19. Percentage of participants reporting missed days of school or work due to adverse events within 1 month after Vaccination 3 in Group 2 [ Time Frame: within 1 month after Vaccination 3 in Group 2 ]
    Describe frequency of missed days of school or work due to AEs within 1 month after Vaccination 3 in Group 2


Secondary Outcome Measures :
  1. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 1 month after the first dose of MenABCWY in Group 1 ]
    Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 12-month schedule

  2. Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 1 month after the first dose of MenABCWY in Group 2 ]
    Describe the immune response for ACWY induced by 1 dose of MenABCWY administered on a 0-, 36-month schedule

  3. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 1 month after the second dose of MenABCWY in Group 1 ]
    Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule

  4. Percentage of participants in Group 2 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 1 month after the second dose of MenABCWY in Group 2 ]
    Describe the immune response for ACWY induced by 2 doses of MenABCWY administered on a 0-, 36-month schedule

  5. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains [ Time Frame: 12 months after the second dose of MenABCWY in Group 1 ]
    Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule

  6. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for 4 primary MenB test strains [ Time Frame: 24 months after the second dose of MenABCWY in Group 1 ]
    Describe the persistence of the MenB immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule

  7. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 12 months after the second dose of MenABCWY in Group 1 ]
    Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule

  8. Percentage of participants in Group 1 achieving a serum bactericidal assay using human complement (hSBA) titer >= lower limit of quantitation (LLOQ) for each ACWY test strain [ Time Frame: 24 months after the second dose of MenABCWY in Group 1 ]
    Describe the persistence of the ACWY immune response induced by 2 doses of MenABCWY administered on a 0-, 12-month schedule


Eligibility Criteria
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Ages Eligible for Study:   11 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04440176


Locations
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Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04440176    
Other Study ID Numbers: C3511004
2019-004923-19 ( EudraCT Number )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: September 26, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Pfizer:
pentavalent meningococcal vaccine
Additional relevant MeSH terms:
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Vaccines
Immunologic Factors
Physiological Effects of Drugs