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Melatonin and Vaccine Response, Immunity, and Chronobiology Study

NCT04953754 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2023-10-10

No results posted yet for this study

Summary

This study will evaluate the impact of sleep, circadian health and melatonin on flu vaccine immunogenicity.

Conditions

  • Vaccine Response
  • Sleep
  • Circadian Rhythm Disorders

Interventions

DIETARY_SUPPLEMENT

Melatonin

The melatonin group will receive 5mg melatonin nightly

DEVICE

Phillips Actiwatch Spectrum Plus

Both groups will be monitored by the FDA-cleared Actigraph

Sponsors & Collaborators

  • Naval Medical Research Center

    collaborator FED

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Janine Danko, MD · Naval Medical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-25
Primary Completion
2024-06-30
Completion
2025-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04953754 on ClinicalTrials.gov