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NCT07636525 · ClinicalTrials.gov registry record
Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study
A clinical trial, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- 66
- Enrollment target
NCT07636525: Recruiting study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT07636525 is a clinical trial that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 66 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07636525 is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- 66 participants
- Enrollment target
Study Summary
The main reason for this research study is to understand whether the sleep habits of 11-12 years-olds impact their response to a vaccine. The vaccine is called MCV4. It protects against meningococcal illness, which is rare but can be severe. The American Academy of Pediatrics recommends that the vaccine be given at age 11 or 12. The vaccine has been approved for youth in this age range for over 20 years and is one of the vaccines that primary care doctors typically give around this age. However, 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. We want to look at that issue in a younger age range. Participating families will be asked to have their child keep their regular sleep schedule during the 5-week study, without much variation. During that time, 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. Each visit will last 1 - 1 ½ hours. The first visit will happen at the end of the 1st week. The second is at the end of the 5th week. During visits, they will fill out forms and we will get data from the wristwatch. During the first visit, the participating child would get the vaccine. During the second, they will have a blood test.
Primary Outcome
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.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2026-07 |
| Est. Completion | 2027-07 |
What NCT07636525 shows while recruiting
NCT07636525 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 66 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT07636525 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07636525 about?
NCT07636525 is a clinical study titled "Sleep and Adolescent Vaccine Immunogenicity Pilot/Observational Study". The main reason for this research study is to understand whether the sleep habits of 11-12 years-olds impact their response to a vaccine. The vaccine is called MCV4. It protects against meningococcal illness, which is rare but can be severe. The American Academy of Pediatrics recommends that the vac...
What is the current status of trial NCT07636525?
This trial is currently recruiting. The enrollment target is 66 participants. The study started on 2026-07. Estimated completion is 2027-07.
Who is sponsoring clinical trial NCT07636525?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
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