Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by… (NCT01889836) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study in Young Adults the Meningococcal Serogroup C Vaccine Produced by Bio-Manguinhos
Brazil60 participantsStarted 2014-05
Plain-language summary
Clinical trial phase I, randomized, double blind, where 30 individuals will receive the experimental vaccine while 30 other volunteers will receive a meningococcal C conjugate vaccine already licensed in Brazil and available in the National Immunization Program for children less than 12 months of age. The primary outcome of the study is to evaluate the safety profile of the vaccine under test, which should allow its application in humans. Secondly, the investigators will study its immunogenicity from the evaluation of the correlates of seroprotection for meningococcal, defined by the World Health Organization (WHO).
Who can participate
Age range
18 Years – 50 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:
* Both sexes.
* Age between 18 and 50.
* Available for follow-up during the period of the study
* Willing to provide their name, address, telephone number and other information by each they can be contact for the study learn if necessary (eg in case of lack the scheduled visit).
* Willing to strictly follow the study protocol.
* Ability to understand and signing the consent form.
* Understanding the impossibility to participate in another clinical trial during the time which is participating in the study.
* Intellectual level that allows filling in the forms for registration of symptoms at home.
* Acceptance for serological testing for human immunodeficiency virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV).
* Be in good health, with no significant medical history.
* Physical examination screening without significant clinical changes.
* Screening laboratory tests within normal limits established the laboratory or abnormal values smaller than 1 degree.
* Additional criterion for females: Negative pregnancy test before application of the vaccine dose, for women of childbearing age.
Exclusion Criteria:
\- Pregnant or breast-feeding.
Personal history of:
* Meningitis of any kind.
* Serious adverse reaction to any vaccination, such as difficulty breathing, angioedema and anaphylaxis.
* Severe adverse reaction related to prior immunization with tetanus and / or diphtheria vaccines alone or in combination vaccines.
* Vaccination with tetanus a…
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
Evaluate the safety of the meningococcal C vaccine by Bio-Manguinhos/Fiocruz for use in humans.
Timeframe: Adverse events post vaccination will be evaluated on days 1,3, 10 and 15 by phone call and on days 2, 7 and 30 at the research center
Trial details
NCT IDNCT01889836
SponsorThe Immunobiological Technology Institute (Bio-Manguinhos) / Oswaldo Cruz Foundation (Fiocruz)