Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) (NCT01123941) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
Belgium50 participantsStarted 2010-05
Plain-language summary
This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197 conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently licensed Vi polysaccharide vaccine.
Who can participate
Age range
18 Years – 40 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
. Males and females of age ≥18 to ≤40 years.
. Individuals who, after the nature of the study has been explained to them, have given written consent according to local regulatory requirements.
. Individuals in good health as determined by the outcome of medical history, physical examination, hematological / hematochemical blood tests and urinalysis and clinical judgment of the investigator.
. If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration
Exclusion criteria
. Individuals with behavioral or cognitive impairment or psychiatric disease that, in the opinion of the investigator, may interfere with the subject's ability to participate in the study.
. Individuals with any progressive or severe neurological disorder, seizure disorder or Guillain-Barré syndrome.
. Individuals who are not able to understand and to follow all required study procedures for the whole period of the study.
. Individuals with history of any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
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
Number of Subjects Reporting Any Post Immunization Reactions
Timeframe: During the 7-day period after vaccination
2
Number of Subjects Reporting Adverse Events
Timeframe: During the 28-day period after vaccination
3
Number of Subjects Reporting Serious Adverse Events (SAEs)
Timeframe: During the 6-month period after vaccination
. Individuals with known or suspected HIV infection or HIV related disease, with history of an autoimmune disorder or any other known or suspected impairment /alteration of the immune system, or under immunosuppressive therapy including use of systemic corticosteroids or chronic use of inhaled high-potency corticosteroids within the previous 30 days, or were in chemotherapy treatment within the past 6 months.
. Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
. Individuals with any serious chronic or progressive disease according to judgment of the investigator.
. Individuals who have any malignancy or lymphoproliferative disorder.