Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04440163
Recruitment Status : Recruiting
First Posted : June 19, 2020
Last Update Posted : June 23, 2020
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Meningococcal Vaccine Biological: MenABCWY Biological: Saline Biological: Trumenba Biological: MenACWY-CRM Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2413 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : June 17, 2020
Estimated Primary Completion Date : April 19, 2022
Estimated Study Completion Date : April 19, 2022

Arm Intervention/treatment
Experimental: 1-Immuno Subset (ACWY Naive,MenABCWY/Saline)
ACWY Naive subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis groups A, B, C, W, and Y vaccine

Biological: Saline
Placebo

Experimental: 2-Immuno Subset (ACWY Naive, Trumenba/MenACWY-CRM)
ACWY Naive subjects, Trumenba/MenACWY-CRM
Biological: Trumenba
Bivalent recombinant lipoprotein 2086 vaccine

Biological: MenACWY-CRM
Meningococcal group A, C, W-135, and Y conjugate vaccine

Experimental: 3-Immuno Subset (ACWY Experienced,MenABCWY/Saline)
ACWY Experienced subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis groups A, B, C, W, and Y vaccine

Biological: Saline
Placebo

Experimental: 4-Immuno Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
ACWY Experienced subjects, Trumenba/MenACWY-CRM
Biological: Trumenba
Bivalent recombinant lipoprotein 2086 vaccine

Biological: MenACWY-CRM
Meningococcal group A, C, W-135, and Y conjugate vaccine

Experimental: 5-Safety Subset (ACWY Naive,MenABCWY/Saline)
ACWY Naive subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis groups A, B, C, W, and Y vaccine

Biological: Saline
Placebo

Experimental: 6-Safety Subset (ACWY Naive,Trumenba/MenACWY-CRM)
ACWY Naive subjects, Trumenba/MenACWY-CRM
Biological: Trumenba
Bivalent recombinant lipoprotein 2086 vaccine

Biological: MenACWY-CRM
Meningococcal group A, C, W-135, and Y conjugate vaccine

Experimental: 7-Safety Subset (ACWY Experienced,MenABCWY/Saline)
ACWY Experienced subjects, MenABCWY/Saline
Biological: MenABCWY
N meningitidis groups A, B, C, W, and Y vaccine

Biological: Saline
Placebo

Experimental: 8-Safety Subset (ACWY Experienced,Trumenba/MenACWY-CRM)
ACWY Experienced subjects, Trumenba/MenACWY-CRM
Biological: Trumenba
Bivalent recombinant lipoprotein 2086 vaccine

Biological: MenACWY-CRM
Meningococcal group A, C, W-135, and Y conjugate vaccine




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT04440163


Contacts
Layout table for location contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
Show Show 22 study locations
Sponsors and Collaborators
Pfizer
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Additional Information:
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT04440163    
Other Study ID Numbers: C3511001
2019-004313-13 ( EudraCT Number )
First Posted: June 19, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No