Meningococcal Immunisation (Healthy Volunteers)Phase 3NCT04368429
Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single Dose of a Meningococcal Reference Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
A Phase 3 study testing Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) and Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people with Meningococcal Immunisation (Healthy Volunteers), run by Sanofi at 4 sites in Japan.
Trial summary
Primary Objective: To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed… Read more about this study
- Who is it for?
- Ages 2 to 55 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) and Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 4 sitesJapan
- Study dates
- 22 May 2020to 7 Nov 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 2 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 2 to 55 years on the day of inclusion.
- Informed consent form had been signed and dated by the participants or participants' parents/legally acceptable representatives as applicable. In addition: Participants 7 to 19 years provided written assent.
- Participants (and participants' parents/legally acceptable representatives for the 2 to 19 years age groups) were able to attend all scheduled visits and complied with all study procedures.
Who cannot join
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception* or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
- Effective methods of contraception included oral contraception (pill), intrauterine device, or condoms used with spermicide.
- Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
- Receipt of immune globulins, blood or blood-derived products in the past 3 months.
Show all 22Show 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 study (specifically, but not limited to, subjects with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling 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 study or to a vaccine containing any of the same substances.
- Laboratory confirmed / self-reported thrombocytopenia, contraindicating IM vaccination in the Investigator's judgment
- Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination in the Investigator's judgement.
- History of Guillain-Barre syndrome.
- History of convulsions.
- History of an Arthus-like reaction after vaccination with a tetanus toxoid-containing vaccine and a diphtheria toxoid-containing vaccine within 10 years of the proposed study vaccination.
- Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily.
- Current alcohol abuse or drug addiction.
- Chronic illness that, in the opinion of the Investigator, was at a stage where it might interfere with study conduct or completion.
- Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature greater than or equal to (>=) 99.5 degree Fahrenheit or >= 37.5 degree Celsius). 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
4 sites in 1 country.
Japan4 sites
Investigational Site Number 3920001
Koganeishi
Investigational Site Number 3920004
Nagoya
Investigational Site Number 3920002
Shinjuku-Ku
Investigational Site Number 3920003
Shinjuku-Ku
About this study
Official title: Immunogenicity and Safety of a Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
Primary Objective:
To demonstrate the non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine).
Read more
Secondary Objective:
Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®.
Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Read the detailed description
The duration of each participant's participation in the study was approximately 30 to 44 days.
- Being tested
- Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine), Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
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 Vaccine)Biological
Pharmaceutical form: Liquid solution Route of administration: IM
Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineBiological
Also called Menactra®
Pharmaceutical form: Liquid solution Route of administration: IM
| Study group | Role | What they receive |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Experimental | Participants received a single intramuscular (IM) dose of MenACYW Conjugate vaccine on Day 0. Receives: Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine) |
| Group 2: Menactra® vaccine | Active comparator | Participants received a single IM dose of Menactra® vaccine on Day 0. Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
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.
Measured: Day 30 (post-vaccination)
Secondary outcomes (9)
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
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)
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants With hSBA antibody titers >=1:4 and >=1:8 for serogroups A, C, Y, and W were reported in the outcome measure.
Measured: Day 0 (pre-vaccination); Day 30 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
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); Day 30 (post-vaccination)
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA. Percentage of participants with hSBA titers <1:4, 1:4, 1:8, 1:16,1:32, 1:64, 1:128, 1:256, 1:512, 1:1024, 1:2048 and 1:4096 for serogroups A, C, Y, and W; with hSBA titers of 1:8192 for serogroup Y; and with hSBA titers of 1:8192, 1:16384, 1:32768 for serogroup C were reported.
Measured: Day 30 (post-vaccination)
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Antibody titers against meningococcal serogroups A, C, Y, and W were measured by hSBA.
Measured: From Baseline (Day 0) to Day 30 (post-vaccination)
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. All participants were observed for 30 minutes after vaccination, and any unsolicited systemic AEs occurred during that time were recorded as immediate unsolicited AEs in the CRB.
Measured: Within 30 minutes post-vaccination
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
A solicited reaction was an expected adverse reaction (sign or symptom) observed and reported under the conditions (nature and onset) prelisted (i.e., solicited) in the CRB and considered as related to the administered vaccination. Solicited injection site reactions included pain, erythema, swelling, and induration. Solicited systemic reactions included fever, headache, malaise and myalgia.
Measured: Within 7 days post-vaccination
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination.
Measured: Up to 30 days post-vaccination
Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
An SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event.
Measured: From Day 0 up to 30 days post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2020
- Study start22 May 2020
- Primary completion7 Nov 2020
- Study completion7 Nov 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.
- Other trials for Meningococcal Immunisation (Healthy Volunteers)Studies of the same condition, open and under way.
- More trials run by SanofiThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04368429
- Sponsor's protocol ID
- EFC16335
- Other IDs
- MEQ00068, U1111-1241-8382
- Status last verified
- Sep 2025
- First submitted
- 20 Apr 2020
- 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
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 Single Dose of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Children, Adolescents, and Adults 2 to 55 Years of Age
- ClinicalTrials.gov ID
- NCT04368429
- Acronym / sponsor ID
- EFC16335
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 22 May 2020 (actual)
- Primary completion
- 7 Nov 2020 (actual)
- Study completion
- 7 Nov 2020 (actual)
- First posted
- 29 Apr 2020 (actual)
- Results
- Posted 6 Oct 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 non-inferiority of the antibody responses to meningococcal serogroups A, C, Y, and W following the administration of a single dose of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate vaccine) compared with those observed following the administration of a single dose of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra® vaccine).
Secondary Objective:
Immunogenicity: To describe the antibody responses to the meningococcal serogroups A, C, Y, and W before and 30 days (+14 days) after vaccination with MenACYW Conjugate vaccine or Menactra®.
Safety: To describe the safety profile of MenACYW Conjugate vaccine and that of Menactra®.
Detailed description
The duration of each participant's participation in the study was approximately 30 to 44 days.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: MenACYW Conjugate Vaccine | Experimental | Biological: Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine)Participants received a single intramuscular (IM) dose of MenACYW Conjugate vaccine on Day 0. |
| Group 2: Menactra® vaccine | Active comparator | Biological: Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineParticipants received a single IM dose of Menactra® vaccine on Day 0. |
Who may qualify
- Ages
- 2 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Aged 2 to 55 years on the day of inclusion.
- Informed consent form had been signed and dated by the participants or participants' parents/legally acceptable representatives as applicable. In addition: Participants 7 to 19 years provided written assent.
- Participants (and participants' parents/legally acceptable representatives for the 2 to 19 years age groups) were able to attend all scheduled visits and complied with all study procedures.
Key exclusion criteria (22 listed)
- Participant was pregnant, or lactating, or of childbearing potential (to be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, surgically sterile, or using an effective method of contraception* or abstinence from at least 4 weeks prior to vaccination until at least 4 weeks after vaccination).
- Effective methods of contraception included oral contraception (pill), intrauterine device, or condoms used with spermicide.
- Participation in the 4 weeks preceding the study vaccination or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.
- Receipt of any vaccine in the 4 weeks preceding the study vaccination or planned receipt of any vaccine prior to Visit 2 except for influenza vaccination, which may be received at least 2 weeks before or after the study investigational vaccines. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
- Previous vaccination against meningococcal disease with either the study vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or Conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B vaccine).
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 Vaccine)Pharmaceutical form: Liquid solution Route of administration: IM | Biological | Group 1: MenACYW Conjugate Vaccine |
| Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate VaccineAlso: Menactra®Pharmaceutical form: Liquid solution Route of administration: IM | Biological | Group 2: Menactra® vaccine |
Primary outcome
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis
Time frame: Day 30 (post-vaccination)
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.
9 secondary outcomes
Percentage of Participants With Vaccine Seroresponse For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Day 30 (post-vaccination)
Percentage of Participants With hSBA Antibody Titer >=1:4 and >=1:8 Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Day 0 (pre-vaccination); Day 30 (post-vaccination)
Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Day 0 (pre-vaccination); Day 30 (post-vaccination)
Percentage of Participants With hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Day 30 (post-vaccination)
Percentage of Participants With >=4-Fold Rise In hSBA Titers Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: From Baseline (Day 0) to Day 30 (post-vaccination)
Number of Participants Reporting Immediate Adverse Events (AEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Within 30 minutes post-vaccination
Number of Participants Reporting Solicited Injection Site And Systemic Reactions Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Within 7 days post-vaccination
Number of Participants Reporting Unsolicited Adverse Events Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: Up to 30 days post-vaccination
Number of Participants Reporting Serious Adverse Events (SAEs) Following Vaccination With MenACYW Conjugate and Menactra® Vaccine
Time frame: From Day 0 up to 30 days post-vaccination
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.
- EFC16335 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
4 sites in 1 country: 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) and Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in people with Meningococcal Immunisation (Healthy Volunteers), run by Sanofi at 4 sites in Japan.
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 3 inclusion and 22 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 4 sites in Japan. 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 6 Oct 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 For Meningococcal Serogroup A, C, Y And W Following Vaccination With MenACYW Conjugate and Menactra® Vaccine: Non-Inferiority Analysis (time frame: Day 30 (post-vaccination)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.