Meningococcal Immunisation (Healthy Volunteers)Phase 3NCT04084769
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)
A Phase 3 study testing Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Meningococcal Group B vaccine (Trumenba®) and Meningococcal group B vaccine (Bexsero®) in people with Meningococcal Immunisation (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 30 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 13 to 26 yearsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Immunisation (Healthy Volunteers)
- What is being tested?
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Meningococcal Group B vaccine (Trumenba®) and Meningococcal group B vaccine (Bexsero®)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 570 participants
- Where
- 30 sitesin 2 countries
- Study dates
- 3 Sep 2019to 14 Sep 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 26 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged >= 13 to less than (<) 26 years on the day of inclusion.
- 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.
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, 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.
- Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature >= 100.4 degree Fahrenheit). A prospective participant should not be included in the study until the condition had resolved or the febrile event had subsided.
- Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw.
- Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (i.e, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.
- The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Trial locations and contacts
30 sites in 2 countries.
30 sites in 2 countries
United States29 sites
Investigational Site Number 8400013
Bardstown, Kentucky, 40004
Investigational Site Number 8400012
Birmingham, Alabama, 35205
Investigational Site Number 8400034
Bridgeton, Missouri, 63044
Investigational Site Number 8400039
Charleston, South Carolina, 29414
Investigational Site Number 8400037
Charlottesville, Virginia, 22903
Investigational Site Number 8400030
Dayton, Ohio, 45414
Investigational Site Number 8400038
Erie, Pennsylvania, 16505
Investigational Site Number 8400031
Kaysville, Utah, 84037
Investigational Site Number 8400018
Kingsport, Tennessee, 37660
Investigational Site Number 8400001
Layton, Utah, 84041
Investigational Site Number 8400014
Layton, Utah, 84041
Investigational Site Number 8400033
Lexington, Kentucky, 40517
Investigational Site Number 8400027
Lincoln, Nebraska, 68504
Investigational Site Number 8400002
Lincoln, Nebraska, 68505
Investigational Site Number 8400004
Lincoln, Nebraska, 68516
Investigational Site Number 8400009
Norman, Oklahoma, 73069
Investigational Site Number 8400040
Orem, Utah, 84057
Investigational Site Number 8400011
Provo, Utah, 84064
Investigational Site Number 8400023
Roy, Utah, 84067
Investigational Site Number 8400003
Salt Lake City, Utah, 84107
Investigational Site Number 8400007
Salt Lake City, Utah, 84109
Investigational Site Number 8400022
Salt Lake City, Utah, 84109
Investigational Site Number 8400005
San Diego, California, 92123-1881
Investigational Site Number 8400028
South Euclid, Ohio, 44121
Investigational Site Number 8400015
South Jordan, Utah, 84095
Investigational Site Number 8400036
South Jordan, Utah, 84095
Investigational Site Number 8400032
Syracuse, Utah, 84075-9645
Investigational Site Number 8400029
Tullahoma, Tennessee, 37388
Investigational Site Number 8400024
West Jordan, Utah, 84088-8865
About this study
Official title: Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
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:
Read more
- 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).
Read the detailed description
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.
Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.
- Being tested
- Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Meningococcal Group B vaccine (Trumenba®), Meningococcal group B vaccine (Bexsero®)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccineBiological
Pharmaceutical form: Solution for injection Route of administration: IM
Meningococcal Group B vaccine (Trumenba®)Biological
Also called Trumenba®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
Meningococcal group B vaccine (Bexsero®)Biological
Also called Bexsero®
Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine; Biological: Meningococcal group B vaccine (Bexsero®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: 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%.
Measured: 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
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.
Measured: 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
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8.
Measured: 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
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Measured: 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
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.
Measured: 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
Antibody titers against meningococcal serogroups A, C, W, and Y were measured by hSBA. Seroprotection were defined as hSBA titer >=1:8.
Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
GMTs of Antibodies 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
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8.
Measured: Day 0 (pre-vaccination) in study MET59
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Measured: Day 0 (pre-vaccination) in study MET59
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8.
Measured: Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-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, 3 and 4
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.
Measured: Day 30 (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, 3 and 4
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Seroprotection was defined as hSBA titer >=1:8.
Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4
GMTs of antibodies against meningococcal serogroups A, C, Y, and W were measured by hSBA. Titers were expressed in terms of 1/dilution.
Measured: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start3 Sep 2019
- Primary completion14 Sep 2020
- Study completion14 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meningococcal Immunisation (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi Pasteur, a Sanofi Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084769
- Sponsor's protocol ID
- MET59
- Other IDs
- U1111-1217-2137, 2019-004461-41, 2019
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2019
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Publications
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.
PubMed 36899125
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of a Booster Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Adolescents and Adults
- ClinicalTrials.gov ID
- NCT04084769
- Acronym / sponsor ID
- MET59
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 14 Sep 2020 (actual)
- First posted
- 10 Sep 2019 (actual)
- Results
- Posted 30 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Study duration per participant was approximately 6 months including: 1 day of screening and vaccination, 1 or 2 additional visits at Day 6 and Day 30, 2 phone calls and a safety follow-up/end of study visit, at Day 8 and Day 180 after vaccine administration, respectively.
Safety assessment included solicited reactions within 7 days after vaccination, unsolicited adverse events (AEs) up to 30 days after vaccination, serious adverse events (SAEs) throughout the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group 1: MenACYW Conjugate vaccine | Experimental | Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccineParticipants 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). |
| Group 2: MenACYW Conjugate vaccine (Menveo Vaccine-primed) | Experimental | Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccineParticipants 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). |
| Group 3: MenACYW Conjugate vaccine + Trumenba vaccine | Experimental | Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Biological: Meningococcal Group B vaccine (Trumenba®)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). |
| Group 4: MenACYW Conjugate vaccine + Bexsero vaccine | Experimental | Biological: Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Biological: Meningococcal group B vaccine (Bexsero®)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). |
Who may qualify
- Ages
- 13 to 26 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Aged >= 13 to less than (<) 26 years on the day of inclusion.
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccinePharmaceutical form: Solution for injection Route of administration: IM | Biological | 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®)Also: Trumenba®Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM | Biological | Group 3: MenACYW Conjugate vaccine + Trumenba vaccine |
| Meningococcal group B vaccine (Bexsero®)Also: Bexsero®Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM | Biological | Group 4: MenACYW Conjugate vaccine + Bexsero vaccine |
Primary outcome
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
Time frame: Day 30 (post-vaccination) in study MET59
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%.
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
Time frame: Day 30 (post-vaccination) in study MET59
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%.
13 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
GMTs of Antibodies 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
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Percentage of Participants With Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0
Time frame: Day 0 (pre-vaccination) in study MET59
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0
Time frame: Day 0 (pre-vaccination) in study MET59
Percentage of Participants Achieving Vaccine Seroprotection Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post-Vaccination in Study MET50 or MET43
Time frame: Day 0 (pre-vaccination), Day 30 (post-vaccination) in study MET50 or MET43
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W at Day 0 and 30 Days Post Vaccination in Either Study MET50 or MET43 and Pre Vaccination in Study MET59
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET50 or MET43; Day 0 (pre-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, 3 and 4
Time frame: Day 30 (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, 3 and 4
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
GMTs of Antibodies Against Meningococcal Serogroups A, C, Y, and W Following Vaccination With MenACYW Conjugate Vaccine in Study MET59: Group 1, 3 and 4
Time frame: Day 0 (pre-vaccination) and Day 30 (post-vaccination) in study MET59
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36899125Zambrano 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.
- MET59 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi Pasteur, a Sanofi Company
30 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine, Meningococcal Group B vaccine (Trumenba®) and Meningococcal group B vaccine (Bexsero®) in people with Meningococcal Immunisation (Healthy Volunteers), run by Sanofi Pasteur, a Sanofi Company at 30 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?
The sponsor lists 7 inclusion and 20 exclusion criteria. 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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 (time frame: Day 30 (post-vaccination) in study MET59). The study lists 2 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 NCT04084769, which also lists 1 linked publication.
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 15 Sep 2025.