Study to Evaluate the Immune Response After a Booster Dose of a Quadrivalent Meningococcal (MenACYW) Conjugate Vaccine When Administered Alone or Concomitantly With a Licensed Meningococcal Serogroup B Vaccine, in Participants Who Received Primary Quadrivalent Meningococcal Conjugate Vaccine (MCV4)

NCT04084769 | Completed Phase 3 Results FDA Drug

• 3 other identifiers: MET59U1111-1217-21372019-004461-41
• Study Type: interventional
• Target: 570
• Locations: 2 countries
• Sites: 30

Brief Summary

Primary Objective: To demonstrate the vaccine seroresponse sufficiency of meningococcal serogroups A, C, Y, and W following the administration of a booster dose of meningococcal Polysaccharide (Serogroups A, C, Y and W) Tetanus Toxoid (MenACYW) Conjugate vaccine:

• In Group 1 participants who were first vaccinated with 1 dose of MenACYW Conjugate vaccine 3-6 years before the booster dose.
• In Group 2 participants who were first vaccinated with 1 dose of Menveo vaccine (meningococcal \[Groups A, C, Y and W135\] Oligosaccharide Diphtheria CRM197 Conjugate vaccine) 3-6 years before the booster dose. Secondary Objective: To describe:
• The vaccine seroresponse, seroprotection (serum bactericidal assay using human complement \[hSBA\] titer greater than or equal to \[\>=\]1:8), and antibody responses (geometric mean titers \[GMTs\]) of meningococcal serogroups A, C, Y, and W measured using hSBA in serum specimens collected 6 days (±1 day) after vaccination in a subset of 50 participants per group (Groups 1 and 2).
• The vaccine seroresponse, seroprotection (hSBA titer \>=1:8), and antibody responses (GMTs) to serogroups A, C, Y, and W measured using hSBA on Day (D)0 (pre-vaccination) and D30 (+14 days) after vaccination with MenACYW Conjugate vaccine alone (Groups 1 and 2).
• The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \>=1:8) of meningococcal serogroups A, C, Y, and W before a booster dose in participants who received either MenACYW Conjugate vaccine or Menveo vaccine 3-6 years earlier.
• The antibody persistence (GMTs and vaccine seroprotection; hSBA titer \>=1:8) of meningococcal serogroups A, C, Y, and W in participants who received either a single dose MenACYW Conjugate vaccine (participants randomized to MET59 Groups 1, 3, and 4) or Menveo vaccine (participants assigned to MET59 Group 2), as part of study MET50, or MET43 (participants randomized to MET59 Groups 1, 3 and 4).
• To describe the vaccine seroresponse, seroprotection (hSBA titer \>=1:8), and antibody responses (GMTs) to the antigens present in MenACYW Conjugate vaccine, when MenACYW Conjugate vaccine was given concomitantly with meningococcal serogroup B (MenB) vaccine (Groups 3 and 4), compared to those when it was given alone (Group 1).

Conditions

Meningococcal Immunisation (Healthy Volunteers)

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1

  Antibody titers against meningococcal serogroups A, C, Y, and W were measured by Serum Bactericidal Assay Using Human Complement (hSBA). The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer greater than or equal to (\>=) 1:16 for participants with pre-vaccination hSBA titer less than (\<) 1:8, or a \>= 4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>= 1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.

  Day 30 (post-vaccination) in study MET59

• Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 2

  Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. The hSBA vaccine seroresponse was defined as a post-vaccination hSBA titer \>=1:16 for participants with pre-vaccination hSBA titer \<1:8, or a \>=4-fold increase in hSBA titer from pre-vaccination to post-vaccination for participants with pre-vaccination hSBA titer \>=1:8. Immune response was considered sufficient if lower limit of the 1-sided 97.5% CI for percentage of participants with hSBA seroresponse against serogroups A, C, Y and W was greater than 75%.

  Day 30 (post-vaccination) in study MET59

Secondary Outcomes (13)

• Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

  Day 6 (post-vaccination) in study MET59

• Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

  Day 6 (post-vaccination) in study MET59

• Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

  Day 6 (post-vaccination) in study MET59

• Percentage of Participants With Vaccine Seroresponse Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

  Day 30 (post-vaccination) in study MET59

• Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and at Day 30 Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1 and 2

  Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59

Study Arms (4)

Group 1: MenACYW Conjugate vaccine

EXPERIMENTAL

Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 (NCT02199691) or MET43 (NCT02842853), received a single intramuscular (IM) dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine

Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed)

EXPERIMENTAL

Participants who received a single dose of Menveo vaccine in previous study MET50 or outside of Sanofi Pasteur trials, received a single IM dose of MenACYW Conjugate vaccine, at Day 0 in the present study (MET59).

Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine

Group 3: MenACYW Conjugate vaccine + Trumenba vaccine

EXPERIMENTAL

Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Trumenba vaccine at Day 0 in the present study (MET59).

Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine; Biological: Meningococcal Group B vaccine (Trumenba®)

Group 4: MenACYW Conjugate vaccine + Bexsero vaccine

EXPERIMENTAL

Participants who received a single dose of MenACYW Conjugate vaccine in previous studies MET50 or MET43, received a single IM dose of MenACYW Conjugate vaccine, concomitantly with 1 dose of Bexsero vaccine at Day 0 in the present study (MET59).

Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine; Biological: Meningococcal group B vaccine (Bexsero®)

Interventions

Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine BIOLOGICAL

Pharmaceutical form: Solution for injection Route of administration: IM

Group 1: MenACYW Conjugate vaccine; Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed); Group 3: MenACYW Conjugate vaccine + Trumenba vaccine; Group 4: MenACYW Conjugate vaccine + Bexsero vaccine

Meningococcal Group B vaccine (Trumenba®) BIOLOGICAL

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

Also known as: Trumenba®

Group 3: MenACYW Conjugate vaccine + Trumenba vaccine

Meningococcal group B vaccine (Bexsero®) BIOLOGICAL

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

Also known as: Bexsero®

Group 4: MenACYW Conjugate vaccine + Bexsero vaccine

Eligibility Criteria

• Age: 13 Years - 26 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Participants participated in and completed study MET50 (MET50 Groups 1, 2, or 3 only) or study MET43 (MET43 Groups 1, 2, or 3 only).
• For MET59 Group 2 only (Menveo vaccine-primed participants only; enrichment population): participants had a documented record of having received 1 dose of Menveo vaccine 3-6 years earlier either as part of a clinical trial or as routine vaccination. Participants who participated in MET50 Group 4 can be enrolled if they fulfill this criterion.
• Participants aged 13 to \< 18 years: assent form had been signed and dated by the participant and informed consent form (ICF) had been signed and dated by the parent or guardian.
• Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: ICF had been signed and dated by the participants.
• Participant aged 13 to \< 18 years: both the participant and parent or guardian were able to attend all scheduled visits and complied with all trial procedures.
• Participants aged \>=18 (or legal age of majority, if different from 18 years of age) to \< 26 years: able to attend all scheduled visits and complied with all trial procedures.

You may not qualify if:

• Participant was pregnant, or lactating, or of childbearing potential and not using an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination until at least 4 weeks after the last vaccination. To be considered of non-childbearing potential, a female must be pre-menarche, or post-menopausal for at least 1 year, or surgically sterile.
• Participation in the 4 weeks preceding the trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
• Receipt of any vaccine in the 4 weeks (28 days) preceding the trial vaccination or planned receipt of any vaccine before Visit 3 (Day 30) except for influenza vaccination, which might be received at least 2 weeks before study investigational vaccine.
• Receipt of immune globulins, blood or blood-derived products in the past 3 months.
• Receipt of any meningococcal vaccine including a licensed or investigational MenACWY vaccine or MenB vaccine since participation in study MET50 or MET43.
• Menveo vaccine-primed participants only (enrichment group for Group 2): receipt of more than 1 dose of Menveo vaccine or vaccination with another licensed or investigational MenACWY vaccine or with a licensed or investigational MenB vaccine.
• Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
• History of meningococcal infection, confirmed either clinically, serologically, or microbiologically.
• At high risk for meningococcal infection during the trial (specifically but not limited to participants with persistent complement deficiency, with anatomic or functional asplenia, or participants travelling to countries with high endemic or epidemic disease).
• Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the trial or to a vaccine containing any of the same substances.
• Personal history of Guillain-Barré syndrome.
• Personal history of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine within at least 10 years of the proposed study vaccination.
• Verbal report of thrombocytopenia, contraindicating IM vaccination.
• Current alcohol abuse or drug addiction.
• Chronic illness (e.g., Human immunodeficiency viruses, hepatitis B, hepatitis C) that, in the opinion of the investigator, was at a stage where it might interfere with trial conduct or completion.

Sponsors & Collaborators

• Sanofi Pasteur, a Sanofi Company: lead

Study Sites (30)

Investigational Site Number 8400012

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 8400005

San Diego, California, 92123-1881, United States

Location

Investigational Site Number 8400013

Bardstown, Kentucky, 40004, United States

Location

Investigational Site Number 8400033

Lexington, Kentucky, 40517, United States

Location

Investigational Site Number 8400034

Bridgeton, Missouri, 63044, United States

Location

Investigational Site Number 8400027

Lincoln, Nebraska, 68504, United States

Location

Investigational Site Number 8400002

Lincoln, Nebraska, 68505, United States

Location

Investigational Site Number 8400004

Lincoln, Nebraska, 68516, United States

Location

Investigational Site Number 8400030

Dayton, Ohio, 45414, United States

Location

Investigational Site Number 8400028

South Euclid, Ohio, 44121, United States

Location

Investigational Site Number 8400009

Norman, Oklahoma, 73069, United States

Location

Investigational Site Number 8400038

Erie, Pennsylvania, 16505, United States

Location

Investigational Site Number 8400039

Charleston, South Carolina, 29414, United States

Location

Investigational Site Number 8400018

Kingsport, Tennessee, 37660, United States

Location

Investigational Site Number 8400029

Tullahoma, Tennessee, 37388, United States

Location

Investigational Site Number 8400031

Kaysville, Utah, 84037, United States

Location

Investigational Site Number 8400001

Layton, Utah, 84041, United States

Location

Investigational Site Number 8400014

Layton, Utah, 84041, United States

Location

Investigational Site Number 8400040

Orem, Utah, 84057, United States

Location

Investigational Site Number 8400011

Provo, Utah, 84064, United States

Location

Investigational Site Number 8400023

Roy, Utah, 84067, United States

Location

Investigational Site Number 8400003

Salt Lake City, Utah, 84107, United States

Location

Investigational Site Number 8400007

Salt Lake City, Utah, 84109, United States

Location

Investigational Site Number 8400022

Salt Lake City, Utah, 84109, United States

Location

Investigational Site Number 8400015

South Jordan, Utah, 84095, United States

Location

Investigational Site Number 8400036

South Jordan, Utah, 84095, United States

Location

Investigational Site Number 8400032

Syracuse, Utah, 84075-9645, United States

Location

Investigational Site Number 8400024

West Jordan, Utah, 84088-8865, United States

Location

Investigational Site Number 8400037

Charlottesville, Virginia, 22903, United States

Location

Investigational Site Number 6300001

San Juan, 00981, Puerto Rico

Location

Related Publications (1)

• Zambrano B, Peterson J, Deseda C, Julien K, Spiegel CA, Seyler C, Simon M, Hoki R, Anderson M, Brabec B, Anez G, Shi J, Pan J, Hagenbach A, Von Barbier D, Varghese K, Jordanov E, Dhingra MS. Quadrivalent meningococcal tetanus toxoid-conjugate booster vaccination in adolescents and adults: phase III randomized study. Pediatr Res. 2023 Sep;94(3):1035-1043. doi: 10.1038/s41390-023-02478-5. Epub 2023 Mar 10.

  PMID: 36899125 DERIVED

Related Links

• MET59 Plain Language Results Summary

MeSH Terms

Interventions

4CMenB vaccine; MenB-FHbp vaccine

Results Point of Contact

• Title: Trial Transparency Team
• Organization: Sanofi Pasteur

Contact-US@sanofi.com

800-633-1610

Study Officials

• Clinical Sciences & Operations

  Sanofi Pasteur, a Sanofi Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The laboratory personnel who performed the serology testing were blinded to the group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Partially-randomized design: all participants primed with MenACYW Conjugate vaccine who meet the inclusion/exclusion criteria were randomly assigned to Group 1, 3, or 4, while participants primed with Menveo vaccine were automatically allocated to Group 2 (not randomized).

Study Record Dates

• First Submitted: September 4, 2019
• First Posted: September 10, 2019
• Study Start: September 3, 2019
• Primary Completion: September 14, 2020
• Study Completion: September 14, 2020
• Last Updated: September 15, 2025
• Results First Posted: August 30, 2021

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

PR (1); US (29)