Phase 3
N=447
Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam
Meningococcal Infection · Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT06228586 ↗Enrolled (actual)
447
Serious AEs
1.1%
Results posted
Sep 2025
Primary outcome: Primary: Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W — 4.44; 7.58; 39.0; 43.2 titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (Biological)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Sanofi Pasteur, a Sanofi Company
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W |
4.44; 7.58; 39.0; 43.2; 2.61; 5.65 | — |
| PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination |
81.5; 66.5; 99.5; 97.7; 96.5; 95.5 | — |
| PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8 |
79.5; 94.1; 25.0; 59.7; 97.5; 89.1 | — |
| PRIMARY Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W |
81.5; 66.5; 99.5; 97.7; 96.5; 95.5 | — |
| PRIMARY Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs) |
0; 1 | — |
| PRIMARY Number of Participants With Solicited Injection Site Reactions and Systemic Reactions |
29; 29; 34; 24 | — |
| PRIMARY Number of Participants With Unsolicited Non-Serious Adverse Events |
48; 11 | — |
| PRIMARY Number of Participants With Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) |
3; 2; 0; 0 | — |
Summary
The MEQ00074 study was a Phase III, open-label, single-center study aimed at describing the immunogenicity and safety of a single dose of investigational quadrivalent Meningococcal Polysaccharide (serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine (MenACYW conjugate vaccine) in participants aged 12 months and older in Vietnam.
The primary objectives of the study were:
* To describe the antibody responses to meningococcal serogroups A, C, W, and Y before and 30 days after the administration of a single dose of MenACYW conjugate vaccine
* To describe the safety profile of a single dose of MenACYW conjugate vaccine The duration of each participant's participation will be approximately 30 to 44 days.
Eligibility Criteria
Inclusion Criteria
- Aged 12 months and above on the day of inclusion
Adults:
- Aged 18 and above on the day of inclusion
- A female participant was eligible to participate if she was not pregnant or breastfeeding and one of the following conditions applies:
- Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or post-menopausal for at least 1 year, or surgically sterile.
- OR Was of childbearing potential and agreed to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.
- Informed consent form was signed and dated
- Was able to attend all scheduled visits and to comply with all study procedures
Adolescents:
- Aged 10 to 17 years on the day of inclusion
- A female participant was eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Was of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche.
- OR Was of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to study intervention administration until at least 4 weeks after study intervention administration.
A female participant of childbearing potential would have a negative highly sensitive pregnancy test (urine) within 1 week before the dose of study intervention.
- Informed consent form was signed and dated by both the participant and the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations Assent form was signed and dated by the participant (assent form required for participants aged 12 to 15 years) or verbal consent was obtained (for participants aged 10 to 11 years), and informed consent form was signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
- Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all study procedures
Children:
- Aged 2 to 9 years on the day of inclusion
- Verbal consent was obtained (for participants aged 7 to 9 years), and informed consent form was signed and dated by the parent(s) or another legally acceptable representative and by an independent witness, if required by local regulations
- Participant and parent/legally acceptable representative were able to attend all scheduled visits and to comply with all study procedures
Toddlers
- Aged 12 to 23 months on the day of inclusion
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative and by an independent witness if required by local regulations
- Participant and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all study procedures
Exclusion Criteria
Participants were excluded from the study if any of the following criteria apply:
Adults (aged 18 years and above), Adolescents (aged 10 to 17 years), Children (aged 2 to 9 years) and Toddlers (aged 12 to 23 months)
- Participation at the time of study enrollment (or in the 4 weeks preceding the trial vaccination) or planned participation during the present trial 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 intervention administration or planned receipt of any vaccine in the 4 weeks following study intervention administration except for influenza vaccination, which may be received at least 2 weeks before or after study vaccine. This exception includes monovalent pandemic influenza
Data sourced from ClinicalTrials.gov (NCT06228586). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.