Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis. (NCT00248833) | Clinical Trial Compass
CompletedPhase 1
Safety and Immunogenicity Study of Group B Meningococcal Vaccine to Prevent Meningitis.
United States34 participantsStarted 2005-12-05
Plain-language summary
The purpose of this study is to determine if the vaccine called Group B Meningococcal 44/76 MOS NOMV 5D Vaccine is safe and free from side effects and if it will protect people from meningitis.
This study will vaccinate three groups of people. In the first 2 groups, the study will be double-blinded. This means that neither the volunteer or the medical team will know which formulation of the vaccine was administered. The third group of volunteers and the medical team will know that they are receiving the higher dose of the vaccine.
Who can participate
Age range
18 Years – 45 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 military or civilian males or non-pregnant, non-lactating females
* Age 18-45
* Give informed consent and understand risk and benefit of study
* Understands and willing to comply with all protocol procedures and time commitment
* FEMALES only: surgically sterilized or received a negative pregnancy test on day of first injection AND agrees to practice adequate birth control, if necessary, for the next 7 months after first vaccination.
Exclusion Criteria:
* Currently has or has had a history of significant organ/system disease
* History of allergy to any vaccine
* Allergy to component of vaccine such as aluminum hydroxide
* Presence of significant unexplained laboratory abnormality
* HIV sero-positive or any other immunosuppressive state
* Positive test for HBsAg, or hepatitis C
* Ongoing drug abuse/dependence
* Received any live vaccine, experimental products or immunosuppressive therapy in the last 28 days or inactivated vaccine in the past 14 days, or received parenteral immunoglobulin or blood products within the past 3 months
* Intention to leave study area for an extended period of time during the study
* Females: positive urine pregnancy test prior to vaccination
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
Safety: Severity Summary of Solicited and Unsolicited Adverse Events
Timeframe: 7 day f/u period after each vaccination
2
Safety: Adverse Event Type Summarized by Dose
Timeframe: 7 days after each vaccination
Trial details
NCT IDNCT00248833
SponsorU.S. Army Medical Research and Development Command