NCT07636525

Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study

Recruiting
Not specifiedAges 11–12Observational
Children's Hospital Medical Center, Cincinnati
~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
Vaccination
1 sites across 1 states
Ohio1
  • Dean W Beebe, Ph.D. · PRINCIPAL_INVESTIGATOR · Children's Hospital Medical Center, Cincinnati

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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.
  • 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.