Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in H… (NCT04143061) | Clinical Trial Compass
CompletedPhase 3
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
India, South Africa1,328 participantsStarted 2019-12-30
Plain-language summary
This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adults, adolescents, children, and toddlers in India and a modified double-blind, randomized, parallel-group, active-controlled, multi-center study to compare and describe the immunogenicity and safety of MenACYW conjugate vaccine when administered as a single dose in healthy adolescents and children in RSA.
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:
\- Age in the defined range on the day of inclusion: For Adults: Aged ≥ 18 years on the day of inclusion For Children and Adolescents: Aged 2 to 17 years on the day of inclusion For Toddlers: Aged 12 to 23 months† on the day of inclusion
\- Z-score of ≥ -2 standard deviations (SD) on the Weight-for-height table of the World Health Organization (WHO) Child Growth Standards: For toddlers and children: Toddlers aged 12 to 23 months and Children aged 2 to 5 years had a Z-score of ≥ -2 SD on the Weight-for-height table of the WHO Child Growth Standards
* Informed consent obtained For adults: Informed consent form has been signed and dated by the subject and by an independent witness, if required by local regulations For toddlers, children, and adolescents: Assent form has been signed and dated by the subject (for subjects 7 to 17 years of age), and informed consent form has been signed and dated by the parent(s) or legally acceptable representative and by an independent witness, if required by local regulations
* Were able to attend all scheduled visits and to comply with all trial procedures For adults: Were able to attend all scheduled visits and to comply with all trial procedures For toddlers, children, and adolescents: Participants and parent / legally acceptable representative were able to attend all scheduled visits and to comply with all trial procedures
* For Toddlers: All toddlers were due to receive an age-recommended RPV on D0
Exclusion Criteria…
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
Group 5 + 7 and Group 6 + 8: Percentage of Participants Who Achieved Antibody Titers ≥1:8 Against Meningococcal Serogroups A, C, Y, and W
Timeframe: Day 30 (30 days post-vaccination on Day 0)