Recruiting

MCV4

Sponsor:

Children's Hospital Medical Center, Cincinnati

Code:

NCT07636525

Conditions

Vaccination

Eligibility Criteria

Sex: All

Age: 11 - 12

Healthy Volunteers: Accepted

Study Details

Brief summary:

This study tests whether the sleep habits of 11-12 years-olds impact their response to a vaccine that protects against meningococcal illness. That vaccine is typically given at that age by primary care doctors, but nobody has studied how sleep affects children's response to it. This could be important because research on adults suggests that sleep affects the immune system.

Families will have their child keep their regular sleep schedule during the 5-week study. They will wear a special wristwatch at night to track their sleep. Each day they will fill out a short online form. They and a parent/guardian will come to Cincinnati Children's twice for 1 - 1 ½ hours. During the first visit, the child get the vaccine. During the second, they have a blood test.

Conditions

Vaccination

Study ID

NCT07636525

Start date

Jul 1, 2026

Status verified date

Oct, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 11 - 12

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy 11-12 years olds who have neither had initial meningococcal vaccination nor known exposure to meningococcal illness.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

66 participants

Anticipated

Interventions and Outcome Measures

Arms

Short Sleepers

Children who regularly sleep <8 hours/night on both weekends and weekdays

Healthy Sleepers

Children who regularly sleep at least 9 hours/night on both weekends and weekdays

Primary outcome measure

  • Antibody titers [ Time Frame: 1 month post-vaccination ]

Central Contacts and Locations

Central contacts

Dean W Beebe, PhD

513-636-3489dean.beebe@cchmc.org

Locations

Cincinnati Children's Hospital Medical Center

Recruiting

Cincinnati, Ohio, United States, 45229

Contacts

Dean Beebe, Ph.D.

513-636-3489dean.beebe@cchmc.org

More Information

Sponsor

Children's Hospital Medical Center, Cincinnati

Last update posted

Oct 19, 2026

Last verified

Oct, 2026

Keywords

  • Sleep

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Children's Hospital Medical Center, Cincinnati on 2026-10-19. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.