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Meningococcal ImmunisationPhase 1/2NCT06128733

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

A Phase 1/2 study testing Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 47 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 10 to 25 yearsHealthy volunteers can take part
What is being tested?
Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,215 participants
Where
47 sitesin 2 countries
Study dates
31 Oct 2023to 27 Aug 2025
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 10 to 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Trial locations and contacts

47 sites in 2 countries.

47 sites in 2 countries

United States46 sites

  • Velocity Clinical Research-Albuquerque- Site Number : 8400101

    Albuquerque, New Mexico, 87107

  • Smart Cures Clinical Research Site Number : 8400072

    Anaheim, California, 92806

  • ~Kentucky Pediatics / Adult Research- Site Number : 8400009

    Bardstown, Kentucky, 40004

  • Accel Research Site - Birmingham Clinical Research Unit- Site Number : 8400080

    Birmingham, Alabama, 35216

  • Progressive Clinical Research- Site Number : 8400028

    Bountiful, Utah, 84010

  • Hope Clinical Research, LLC- Site Number : 8400001

    Canoga Park, California, 91303

  • SPICA Clinical Research Site Number : 8400098

    Columbia, South Carolina, 29223

  • Vida Clinical Studies Site Number : 8400084

    Dearborn Heights, Michigan, 48127-2234

  • Vida Clinical Studies- Site Number : 8400084

    Dearborn Heights, Michigan, 48127-2234

  • Accel Clinical Research-Deland Clinical Research Unit- Site Number : 8400081

    DeLand, Florida, 32720-0834

  • AMR Evansville Site Number : 8400062

    Evansville, Indiana, 47712

  • Apex Research Group Site Number : 8400071

    Fair Oaks, California, 95628

  • SIMEDHealth, LLC- Site Number : 8400045

    Gainesville, Florida, 32607

  • Lakeview Clinical Research Site Number : 8400029

    Guntersville, Alabama, 35976-2206

  • Harrisburg Family Medical Center Site Number : 8400070

    Harrisburg, Arkansas, 72432

  • New Horizon Medical Group-Houston Site Number : 8400069

    Houston, Texas, 77063

  • DM Clinical Research- Bellaire- Site Number : 8400052

    Houston, Texas, 77081

  • Leavitt Clinical Research-Idaho Falls- Site Number : 8400075

    Idaho Falls, Idaho, 83404

  • Snake River Research, PLLC- Site Number : 8400100

    Idaho Falls, Idaho, 83404

  • AMR Utah-Wee Care Pediatrics-Kaysville- Site Number : 8400106

    Kaysville, Utah, 84037

  • Accel Research Sites-St. Petersburg-Largo- Site Number : 8400082

    Largo, Florida, 33777

  • Michael W. Simon, MD, PSC- Site Number : 8400026

    Lexington, Kentucky, 40517

  • Be Well Clinical Studies- Site Number : 8400077

    Lincoln, Nebraska, 68516

  • Alivation Research (Primary Care) Site Number : 8400046

    Lincoln, Nebraska, 68526

  • South Florida Research Organization Site Number : 8400086

    Medley, Florida, 33166

  • Life Arc Research-Miami Site Number : 8400094

    Miami, Florida, 33126

  • Charisma Medical and Research center Site Number : 8400097

    Miami Lakes, Florida, 33014

  • Monroe Biomedical Research - Site Number : 8400099

    Monroe, North Carolina, 28112

  • Alliance for Multispecialty Research- Site Number : 8400107

    Murray, Utah, 84107

  • AMR - Newton- Site Number : 8400104

    Newton, Kansas, 67114

  • Coastal Carolina Research Center - N Charleston- Site Number : 8400050

    North Charleston, South Carolina, 29405

  • Quality Clinical Research, Inc.- Site Number : 8400074

    Omaha, Nebraska, 68114

  • Velocity Clinical Research, Omaha- Site Number : 8400066

    Omaha, Nebraska, 68134

  • Accel Research - Nona Pediatric Center Site Number : 8400079

    Orlando, Florida, 32829

  • Ormond Beach Clinical Research- Site Number : 8400073

    Ormond Beach, Florida, 32174

  • Advances in Health- Pearland- Site Number : 8400078

    Pearland, Texas, 77584

  • AES Peoria- Site Number : 8400090

    Peoria, Illinois, 61614

  • Be Well Clinical Studies -Round Rock Site Number : 8400053

    Round Rock, Texas, 78681

  • Tribe Clinical Research at Parkside Pediatrics-Five Forks Site Number : 8400049

    Simpsonville, South Carolina, 29681

  • Palm Harbor Dermatology- Site Number : 8400030

    Tampa, Florida, 33609

  • PAS Research Site Number : 8400032

    Tampa, Florida, 33613

  • VICIS Clinical Research-Tampa Site Number : 8400065

    Tampa, Florida, 33614

  • Alliance for Multispecialty Research- Phoenix- Site Number : 8400056

    Tempe, Arizona, 85281

  • Prime Global Research, Inc. Site Number : 8400043

    The Bronx, New York, 10456

  • Pediatric Clinical Trials Tullahoma- Site Number : 8400020

    Tullahoma, Tennessee, 37388

  • Velocity Clinical Research-Washington DC Site Number : 8400102

    Washington D.C., District of Columbia, 20016

Other trials in United States

Puerto Rico1 site

  • Investigational Site Number : 6300001

    San Juan, 00918

Other trials in Puerto Rico

About this study

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).

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.

Read the detailed description

The study duration will be approximately 12 months for all participants

Being tested
Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine, Placebo, MenABCYW conjugate vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pentavalent Meningococcal ABCYW vaccineBiological

    Also called MenPenta

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

  • MenACYW conjugate vaccineBiological

    Also called MenQuadFi®

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

  • Meningococcal group B vaccineBiological

    Also called Bexsero®

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

  • Meningococcal group B vaccineBiological

    Also called Trumenba®

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

  • Meningococcal group B vaccineBiological

    Also called Sanofi MenB

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

  • MenACYW conjugate vaccineBiological

    Also called Menveo®

    Pharmaceutical form:Powder and solvent for solution for injection-Route of administration:Intramuscular (IM)

  • PlaceboBiological

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

  • MenABCYW conjugate vaccineBiological

    Also called PENBRAYATM

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

Study groups in NCT06128733
Study groupRoleWhat they receive
Group 1: MenPenta Formulation 1ExperimentalParticipants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Placebo
Group 2: MenPenta Formulation 2ExperimentalParticipants (ACWY naive and primed adults or adolescents) will receive injections of the pentavalent meningococcal ABCYW vaccine and placebo
Receives: Biological: Pentavalent Meningococcal ABCYW vaccine; Biological: Placebo
Group 3: Bexsero® + Menveo®Active comparatorParticipants (ACWY naive and primed adults or adolescents) will receive injections of Bexsero® + Menveo® vaccine
Receives: Biological: Meningococcal group B vaccine; Biological: MenACYW conjugate vaccine
Group 4: Trumenba® + Menveo®Active comparatorParticipants (ACWY naive and primed adults or adolescents) will receive injections of Trumenba® + Menveo® vaccine
Receives: Biological: Meningococcal group B vaccine; Biological: MenACYW conjugate vaccine
Group 5: MenQuadfi®Active comparatorParticipants (ACWY naive and primed adults or adolescents) will receive injections of MenQuadfi® vaccine and placebo
Receives: Biological: MenACYW conjugate vaccine; Biological: Placebo
Group 6: Sanofi MenBExperimentalParticipants (ACWY naive and primed adults or adolescents) will receive injections of SP MenB vaccine and placebo
Receives: Biological: Meningococcal group B vaccine; Biological: Placebo
Group 7: PENBRAYAActive comparatorParticipants (ACWY naive and primed adolescents) will receive injections of PENBRAYA vaccine and placebo
Receives: Biological: MenABCYW conjugate vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Unsolicited systemic AEs that occur within 30 minutes after vaccination

    Measured: Within 30 minutes after each vaccination

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

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

    Measured: Within 7 days after each vaccination

  3. Number of participants with unsolicited AEs

    Non-serious AEs other than solicited reactions

    Measured: Within 30 days after each vaccination

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

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

    Measured: From baseline up to 12 months

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

    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

    Measured: From baseline up to 12 months

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

    Measured: 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

    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)

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

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

    hSBA titers ≥ 1:8

    Measured: Day 211 (for Group 1 to 7)

  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

    Geometric mean titers

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

  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

    Measured: 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

    Seroresponse defined as a 4-fold increase in hSBA titers

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

  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

    hSBA titers ≥ 1:4 for reference MenB strains

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

  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

    hSBA titers ≥ 1:8 for reference MenB strains

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

  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

    Geometric mean titers for the reference MenB strains

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

  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

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

Secondary outcomes (23)

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

    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)

    Measured: 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)

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

    hSBA titers ≥ 1:8 post-vaccination

    Measured: 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)

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

    Geometric mean titers

    Measured: 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)

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

    Measured: 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

    Seroresponse defined as a 4-fold increase in hSBA titers

    Measured: 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)

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

    hSBA titers ≥ 1:4 for reference MenB strains

    Measured: 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)

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

    hSBA titers ≥ 1:8 reference MenB strains

    Measured: 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)

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

    Geometric mean titers for reference MenB strains

    Measured: 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)

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

    Measured: 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

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

    Measured: 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)

  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

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

    Measured: 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)

  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

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

    Measured: 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)

  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

    Geometric mean titers for reference and additional MenB strains

    Measured: 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)

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

    Measured: 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

    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)

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Nov 2023
  2. Study start31 Oct 2023
  3. Primary completion27 Aug 2025
  4. Study completion27 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
1,215 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06128733
Sponsor's protocol ID
VAN00010
Other IDs
U1111-1272-6824, 2023-000924-13, 2023
Status last verified
Jan 2026
First submitted
26 Oct 2023
Last updated
13 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine and Meningococcal group B vaccine in people with Meningococcal Immunisation and Healthy Volunteers, run by Sanofi Pasteur, a Sanofi Company at 47 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with immediate adverse events (AEs) (time frame: Within 30 minutes after each vaccination). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06128733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.

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