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Completed

NCT Number: NCT06128733

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

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.

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Key information

Conditions

Meningococcal Immunisation Healthy Volunteers

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number : 6300001, San Juan, Puerto Rico

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About this study

The study duration will be approximately 12 months for all participants

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

- 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.

Treatment and study plan

Pentavalent Meningococcal ABCYW vaccine

Biological

Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular (IM)

Other names: MenPenta

MenACYW conjugate vaccine

Biological

Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)

Other names: MenQuadFi®

Meningococcal group B vaccine

Biological

Pharmaceutical form:Suspension for injection in pre-filled syringe-Route of administration:Intramuscular (IM)

Other names: Bexsero®

Placebo

Biological

Pharmaceutical form:Solution for injection in vial-Route of administration:Intramuscular (IM)

MenABCYW conjugate vaccine

Biological

Pharmaceutical form: Suspension for injection Route of administration: Intramuscular (IM)

Other names: PENBRAYATM

Primary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: Within 30 days after each vaccination

    Non-serious AEs other than solicited reactions

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

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

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

Sponsors and collaborators

Lead sponsor

Sanofi Pasteur, a Sanofi Company

Industry

Registry information

Official study 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).

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 13, 2023
Registry last updated
Jan 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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