A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 … (NCT01352793) | Clinical Trial Compass
CompletedPhase 3
A Global Phase 3 Safety Study of 120 mcg rLP2086 Vaccine in Adolescents and Young Adults Aged 10 to 25 Years
United States, Australia, Chile5,715 participantsStarted 2012-11
Plain-language summary
A multicenter phase 3 safety trial in which 5,700 subjects will be assigned in a 2:1 ratio to receive 120 μg rLP2086 vaccine in a 0, 2, 6 month schedule or control. The control group will receive HAVRIX vaccine at month 0 and 6 and saline at month 2.
All subjects will be followed for 6 months after the last vaccination to assess safety and tolerability.
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 subjects aged 10 to 25 years.
Exclusion Criteria:
* Previous vaccination with Hepatitis A virus vaccine
* Previous vaccination with investigational meningococcal B vaccine
* History of culture-proven N. meningitidis serogroup B disease
* Any neuroinflammatory or autoimmune condition
* Any immune defect that would prevent an effective response to the study vaccine
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
Percentage of Participants With at Least One Serious Adverse Event (SAE) Throughout the Study
Timeframe: Vaccination 1 up to 6 months after Vaccination 3
2
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 1
Timeframe: Within 30 days after Vaccination 1
3
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 2
Timeframe: Within 30 days after Vaccination 2
4
Percentage of Participants With at Least One Medically Attended Adverse Event Within 30 Days After Vaccination 3