CompletedPhase 3

Study on a MenACYW Conjugate Vaccine Administered as a Single Dose in Participants Aged 12 Months and Older in Vietnam

Vietnam447 participantsStarted 2024-01-18

Plain-language 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.

Who can participate

Age range

12 Months

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Geometric Mean Titers (GMTs) of Antibodies Against Meningococcal Serogroups A, C, Y, and W

Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)

Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=4-Fold Rise From Pre-Vaccination to Post-Vaccination

Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)

Percentage of Participants With Serum Bactericidal Assay Using Human Complement Titers >=1:4 and >=1:8

Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)

Percentage of Participants With Serum Bactericidal Assay Using Human Complement Vaccine Seroresponse for Serogroups A, C, Y, and W

Timeframe: Day 1 (pre-vaccination) and Day 31 (30 days post-vaccination on Day 1)

Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

Timeframe: Up to 30 minutes post-vaccination on Day 1

Number of Participants With Solicited Injection Site Reactions and Systemic Reactions

Timeframe: From the study vaccine administration (Day 1) up to 7 days post-vaccination, up to Day 8

Trial details

NCT IDNCT06228586

SponsorSanofi Pasteur, a Sanofi Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-03-31

Results submitted2025-08-28

View on ClinicalTrials.gov More Meningococcal Infection trials