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Trial record 1 of 1 for:    NCT04440163
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MenABCWY Noninferiority Study in Healthy Participants ≥10 to <26 Years of Age

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ClinicalTrials.gov Identifier: NCT04440163
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : March 1, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE June 15, 2020
First Posted Date  ICMJE June 19, 2020
Last Update Posted Date March 1, 2021
Actual Study Start Date  ICMJE June 17, 2020
Estimated Primary Completion Date April 19, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Percentage of participants achieving at least a 4-fold rise hSBA titer from baseline for each ACWY test strain - Group 1 and 2 [ Time Frame: 1 month after Vaccination 2 in Group 1 compared to 1 month after Vaccination 1 in Group 2 ]
    Demonstrate immune response for Men A, C, W, Y after 2 doses of Men ABCWY is non-inferior to immune response after 1 dose of Men ACWY-CRM in naïve participants
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain - Group 3 and 4 [ Time Frame: 1 month after Vaccination 2 in Group 3 compared to 1 month after Vaccination 1 in Group 4 ]
    Demonstrate immune response for Men A, C, W, Y after 2 doses of Men ABCWY is non-inferior to immune response after 1 dose of Men ACWY-CRM in experienced participants
  • Percentage of participants achieving an hSBA titer ≥ LLOQ for all 4 primary MenB test strains combined (composite response), in Groups 1 and 3 combined compared to Groups 2 and 4 combined [ Time Frame: 1 month after Vaccination 2 ]
    Non Inferiority of 2 doses of Men ABCWY compared to 2 doses of Trumenba
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each of the 4 primary MenB test strains, in Groups 1 and 3 combined compared to Groups 2 and 4 combined [ Time Frame: 1 month after Vaccination 2 ]
    Non Inferiority of 2 doses of Men ABCWY compared to 2 doses of Trumenba
  • Percentage of participants reporting local reactions within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting systemic events within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting use of antipyretic medication within 7 days after each vaccination [ Time Frame: Within 7 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 SAE throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 MAE throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC within 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC within 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC during the follow-up phase [ Time Frame: During Follow-up phase (From one month after 2nd vaccination through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 NDCMC throughout the study. [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE 30 Days after each vaccination [ Time Frame: Within 30 days after each vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE 30 Days after any vaccination [ Time Frame: Within 30 days after any vaccination ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 AE during the vaccination phase [ Time Frame: During vaccination phase (From study entry through one month after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants reporting at least 1 immediate AE [ Time Frame: Throughout the study (From the time of vaccine administration until 30 minutes post vaccine administration) ]
    Describe the safety profile of MenABCWY
  • Percentage of participants who missed days of school or work because of AEs [ Time Frame: Throughout the study (From study entry through 6 months after 2nd vaccination) ]
    Describe the safety profile of MenABCWY
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2020)
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain in Group 1 compared to Group 2. [ Time Frame: 1 month after Vaccination 1 ]
    Non-inferiority of immune response after 1 dose of Men ABCWY compared to 1 dose of Men ACWY-CRM in naïve participants
  • Percentage of participants achieving at least a 4-fold rise in hSBA titer from baseline for each ACWY test strain in Group 3 compared to Group 4. [ Time Frame: 1 month after Vaccination 1 ]
    Non-inferiority of immune response after 1 dose of Men ABCWY compared to 1 dose of Men ACWY-CRM in Experienced participants
  • Percentage of participants achieving an hSBA titer ≥ LLOQ for each secondary MenB test strain in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
  • Percentage of participants with hSBA titers ≥1:4, ≥1:8, ≥1:16, ≥1:32, ≥1:64, and ≥1:128 for each secondary MenB test strain in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
  • hSBA GMTs for the secondary MenB test strains in Groups 1 and 3 combined [ Time Frame: At baseline and 1 month after Vaccination 2 ]
    Immune response for MenB, induced by 2 doses of MenABCWY
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
URL: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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