Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents

NCT06128733
clinicaltrials.gov
Phase
Phase 1/Phase 2
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Recruitment status
Completed
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Participants
1,215
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Start date
2023-10-31
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Number of sites
47
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Summary
The purpose of VAN00010 study is to assess the safety and immunogenicity of the investigational pentavalent meningococcal ABCYW vaccine in adults and adolescents. The study duration will be up to 12 months for all participants.
clinicaltrials.gov
Short title
Study of an Investigational Pentavalent Meningococcal ABCYW Vaccine in Adults and Adolescents
clinicaltrials.gov
Official title
A Phase I/II, Randomized, Descriptive, Safety and Immunogenicity Study to Assess Pentavalent Meningococcal ABCYW Vaccine Formulations in Adults (18 to 25 Years of Age) and Adolescents (10 to 17 Years of Age).
clinicaltrials.gov

Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2025-08-27
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First posted
2023-11-13
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Registry last updated
2026-01-13
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Primary completion date
2025-08-27
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Start date
2023-10-31
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Actual participants
1,215
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Participants
1,215
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
47
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Sanofi Pasteur, a Sanofi Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06128733
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ClinicalTrials.gov ID
NCT06128733
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Prevention
Masking
Triple masking
Masking description
Modified double-blind: in order to maintain the blind, a placebo injection will be given and blood sample will be collected from all participants at each visit
Masked roles
Participants, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Number of participants with immediate adverse events (AEs)

    Timeframe: Within 30 minutes after each vaccination

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

  2. Number of participants with solicited injection site reactions or systemic reactions

    Timeframe: Within 7 days after each vaccination

    Pre-defined solicited injection site reactions and systemic reactions that are pre-listed in the diary cards and CRF

  3. Number of participants with unsolicited AEs

    Timeframe: Within 30 days after each vaccination

    Non-serious AEs other than solicited reactions

  4. Number of participants with serious adverse events (SAEs)

    Timeframe: From baseline up to 12 months

    SAEs (including adverse events of special interest \[AESIs\]) reported throughout the study

  5. Number of participants with medically attended adverse events (MAAEs)

    Timeframe: From baseline up to 12 months

    An MAAE is a new onset or a worsening of a condition that prompts the participant or participant's parent/legally acceptable representative to seek unplanned medical advice at a physician's office or Emergency Department

  6. Number of participants with out-of-range biological test results

    Timeframe: Before each vaccination up to 7 days after primary vaccination visits in the sentinel cohorts (the first 5 participants enrolled in each vaccine group) of each age group

  7. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse pre-dose and 1 month after the second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

    Seroresponse defined as post-second vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-second vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than or equal to the lower limit of quantification (LLOQ)

  8. hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the second dose in adolescent participants

    Timeframe: Day 211 (for Group 1 to 7)

    hSBA titers ≥ 1:8

  9. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 31 Day 211 (for Group 1 to 7)

    Geometric mean titers

  10. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each of serogroups A, C, W, and Y in adolescent participants

    Timeframe: Day 01 (pre-dose) Day 211 (for Group 1 to 7)

  11. hSBA meningococcal serogroup B seroresponse pre-dose and 1 month after second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

    Seroresponse defined as a 4-fold increase in hSBA titers

  12. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

    hSBA titers ≥ 1:4 for reference MenB strains

  13. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

    hSBA titers ≥ 1:8 for reference MenB strains

  14. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-second dose in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

    Geometric mean titers for the reference MenB strains

  15. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adolescent participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 7)

  1. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    Seroresponse defined as post-vaccination titers ≥ 1:16 for participants with pre-vaccination titers \< 1:4 or post-vaccination titer ≥ 4 times the pre-vaccination titer for participants with pre-dose 1 vaccination titers more than the lower limit of quantification (LLOQ)

  2. hSBA meningococcal serogroups A, C, W, and Y antibody titers at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    hSBA titers ≥ 1:8 post-vaccination

  3. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    Geometric mean titers

  4. Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

  5. hSBA meningococcal serogroup B (reference MenB strains) vaccine seroresponse at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    Seroresponse defined as a 4-fold increase in hSBA titers

  6. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    hSBA titers ≥ 1:4 for reference MenB strains

  7. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    hSBA titers ≥ 1:8 reference MenB strains

  8. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) at each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

    Geometric mean titers for reference MenB strains

  9. Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ for reference MenB strains for each timepoint

    Timeframe: D01 (pre-dose) and D31 (post-dose 1 and pre-dose 2), D61 (post-dose 2), D181 (pre-dose 3) and D211 (post-dose 3) for adults (Group 1-6). D01 (pre-dose) and D31 (post-dose 1), D181 (pre-dose 2) and D211 (post-dose 2) for adolescents (Group 1-7)

  10. hSBA meningococcal serogroup B (reference and additional MenB strains) vaccine seroresponse pre-dose 1 and 1 month post-second and third dose in adolescent participants

    Timeframe: Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)

    Seroresponse defined as a 4-fold increase in hSBA titers from D01 to post-vaccination for reference and additional MenB strains

  11. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-second and third dose in adolescent participants

    Timeframe: Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)

    hSBA titers ≥ 1:4 for reference and additional MenB strains

  12. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference and additional MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-second and third dose in adolescent participants

    Timeframe: Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)

    hSBA titers ≥ 1:8 for reference and additional MenB strains

  13. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference and additional MenB strains) pre-dose 1 and 1 month post-second and third dose in adolescent participants

    Timeframe: Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)

    Geometric mean titers for reference and additional MenB strains

  14. Percentage of participants with hSBA composite seroresponse titers more or equal to LLOQ reference and additional MenB strains in adolescent participants

    Timeframe: Day 01 (pre-dose), Day 61 (post-dose 2) and Day 211 (post-dose 3) (for Group 1 to 6 for adults) and Day 211 (for Group 1 to 7 for adolescents)

  15. hSBA meningococcal serogroups A, C, W, and Y vaccine seroresponse 1 month after the third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

    Seroresponse defined as post-third vaccination titers ≥ 1:16 for participants with pre-vaccination hSBA titers \< 1:4 or post-third vaccination titers ≥ 4 times the pre-vaccination titer for participants with a pre-vaccination titer more than the lower limit of quantification (LLOQ)

  16. hSBA meningococcal serogroups A, C, W, and Y antibody titers pre-dose and 1 month after the third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  17. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroups A, C, W and Y pre-dose and 1 month after the third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  18. Percentage of participants with hSBA titers more or equal to LLOQ against each of serogroups A, C, W, and Y in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  19. hSBA meningococcal serogroup B (reference MenB strains) seroresponse pre-dose and 1 month after third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  20. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:4 pre-dose 1 and 1 month post-third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  21. Percentage of Participants With Meningococcal Antibody Titers against meningococcal serogroup B (reference MenB strains) ≥ 1:8 pre-dose 1 and 1 month post-third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  22. Geometric mean titers (GMTs) of Antibodies against Meningococcal Serogroup B (reference MenB strains) pre-dose 1 and 1 month post-third dose in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

  23. Percentage of participants with hSBA titers more or equal to lower limit of quantification (LLOQ) against each and all serogroups B (reference MenB strains) in adult participants

    Timeframe: Day 01 (pre-dose) and Day 211 (for Group 1 to 6)

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Children, Adults
Minimum age
10 Years
Maximum age
25 Years
Healthy volunteers
Yes

  • Aged 18 to 25 years or 10 to 17 years on the day of inclusion
  • Participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, and judgment of the Investigator.
  • Participants who are either unvaccinated with MenACWY vaccine or have received a single previous dose of MenACWY vaccine at least 4 years prior to study enrollment Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
  • Known or suspected congenital or acquired immunodeficiency
  • History of any Neisseria meningitidis infection
  • At high risk for meningococcal infection during the study
  • Individuals with active tuberculosis
  • History of Guillain-Barré syndrome
  • Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sources for eligibility
clinicaltrials.gov

  • Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080Birmingham, United States
  • Lakeview Clinical Research Site Number : 8400029Guntersville, United States
  • Alliance for Multispecialty Research- Phoenix- Site Number : 8400056Tempe, United States
  • Harrisburg Family Medical Center Site Number : 8400070Harrisburg, United States
  • Smart Cures Clinical Research Site Number : 8400072Anaheim, United States
  • Hope Clinical Research, LLC- Site Number : 8400001Canoga Park, United States
  • Apex Research Group Site Number : 8400071Fair Oaks, United States
  • Velocity Clinical Research-Washington DC Site Number : 8400102Washington D.C., United States
  • Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081DeLand, United States
  • SIMEDHealth, LLC- Site Number : 8400045Gainesville, United States
  • Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082Largo, United States
  • South Florida Research Organization Site Number : 8400086Medley, United States
  • Life Arc Research-Miami Site Number : 8400094Miami, United States
  • Charisma Medical and Research center Site Number : 8400097Miami Lakes, United States
  • Accel Research - Nona Pediatric Center Site Number : 8400079Orlando, United States
  • Ormond Beach Clinical Research- Site Number : 8400073Ormond Beach, United States
  • Palm Harbor Dermatology- Site Number : 8400030Tampa, United States
  • PAS Research Site Number : 8400032Tampa, United States
  • VICIS Clinical Research-Tampa Site Number : 8400065Tampa, United States
  • Leavitt Clinical Research-Idaho Falls- Site Number : 8400075Idaho Falls, United States
  • Snake River Research, PLLC- Site Number : 8400100Idaho Falls, United States
  • AES Peoria- Site Number : 8400090Peoria, United States
  • AMR Evansville Site Number : 8400062Evansville, United States
  • AMR - Newton- Site Number : 8400104Newton, United States
  • ~Kentucky Pediatics / Adult Research- Site Number : 8400009Bardstown, United States

And 22 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2023
  • U1111-1272-6824
  • 2023-000924-13
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)