NCT07636525
Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study
Recruiting
Not specifiedAges 11–12ObservationalChildren's Hospital Medical Center, CincinnatiInvestigator-initiated
~66 participants
Updated 2026-06-09 on ClinicalTrials.gov
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Antibody titers
Measured over 1 month post-vaccination
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Dean W Beebe, Ph.D. · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati
Who to contact
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Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.
Exclusion
Condition or treatment resulting in immunosuppression
Prior severe vaccine reaction
Symptoms of clinical insomnia or organic sleep disorder
Known neurologic condition or intellectual/developmental disability
Use of a medication that impacts sleep
Average nightly sleep of 8-8.99 hours (between the two groups)
Daily intake of \>1 coffee or "energy drink" or \>2 caffeinated sodas.
What this trial measures
- Antibody titers1 month post-vaccination
Measured via serum bactericidal assay (SBA), which measures the ability of serum antibodies to kill the meningococcus bacteria in the presence of complement protein. The primary outcome will be the proportion of individuals in each group with a titer greater than or equal to 1:8 for each MCV4 serotype (A, C, W, Y), which is a strong correlate of protection.