Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children (NCT00616421) | Clinical Trial Compass
CompletedPhase 3
Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
United States, Canada2,907 participantsStarted 2008-03
Plain-language summary
To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.
Who can participate
Age range
2 Years – 10 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 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
* who are available for all visits and telephone calls scheduled for the study
* who are up-to-date with age-appropriate routine childhood vaccinations
Exclusion Criteria:
* whose parent or legal guardian is unwilling or unable to give written informed consent
* who had a previous or suspected disease caused by N. meningitidis;
* who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* who have received any investigational agents or vaccines within 90 days prior to enrollment
* who have any serious acute, chronic or progressive disease
* who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
* who have a history of anaphylaxis, serious vaccine reactions
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
* who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
* who have Down's syndrome or other known cytogenic disorders
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 hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
Timeframe: 1 month postvaccination
2
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.