Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young A… (NCT01272180) | Clinical Trial Compass
CompletedPhase 2
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
United States, Poland484 participantsStarted 2011-08
Plain-language summary
This study will evaluate the safety and immunogenicity of combination vaccines as compared to the reference vaccines
Who can participate
Age range
10 Years – 25 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:
* Healthy adolescents aged 10 through 25 years of age inclusive at the time of enrollment.
Exclusion Criteria:
* History of any meningococcal vaccine administration;
* Current or previous, confirmed or suspected disease caused by N. meningitidis;
* Pregnant or nursing (breastfeeding) mothers;
* Females of childbearing age who have not used or do not plan to use acceptable birth control measures, for the duration of the study;
* Any serious, chronic, or progressive disease;
* Known or suspected impairment/alteration of the immune system;
* Receipt of blood, blood products and/or plasma derivatives, or a parenteral immunoglobulin preparation within the previous 90 days;
* History of severe allergic reactions after previous vaccinations or hypersensitivity to any vaccine component.
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
Percentages of Subjects With a Seroresponse Against N.Meningitidis Serogroups A,C,W-135,Y, After Receiving Different Formulations of MenABCWY Combination Vaccine.
Timeframe: One month after the second vaccination (Day 91)
2
Desirability Index for Each Vaccine Group, Based on Immunogenicity and Reactogenicity Parameters.
Timeframe: One month after the second vaccination (Day 91)