Study of a Quadrivalent Meningococcal Conjugate Vaccine as a Single Dose Compared With a Single D… (NCT04368429) | Clinical Trial Compass
CompletedPhase 3
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
Japan360 participantsStarted 2020-05-22
Plain-language 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 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®.
Who can participate
Age range
2 Years – 55 Years
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 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.
Exclusion criteria:
* 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 vac…
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
1
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