Melatonin Group for Vaccine Response

Waitlist Available
Led By Janine Danko, MD
Research Sponsored by Naval Medical Research Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Must not have
Be younger than 18 years old
Be older than 65 years old
Screening 3 weeks
Treatment Varies
Follow Up14-21 days post vaccination
Awards & highlights
No Placebo-Only Group

Study Summary

This trialwill look at how sleep, body clock and melatonin affect how well the flu vaccine works.

Eligible Conditions
  • Vaccine Response
  • Sleep
  • Circadian Rhythm Disorder


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14-21 days post vaccination
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14-21 days post vaccination for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anti-influenza antibody titers
Cell-mediated immunity
Secondary outcome measures
Actigraph data
Chronotype survey - Munich ChronoType Questionaire (MCTQ)
Sleep survey - Pittsburgh Sleep Quality Index (PSQI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Melatonin GroupExperimental Treatment2 Interventions
This group will get melatonin 5mg nightly
Group II: Control GroupActive Control1 Intervention
This group will not get any treatment (melatonin)
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a site

Who is running the clinical trial?

Naval Medical Research CenterLead Sponsor
32 Previous Clinical Trials
2,670 Total Patients Enrolled
Walter Reed National Military Medical CenterFED
129 Previous Clinical Trials
36,466 Total Patients Enrolled
Janine Danko, MDPrincipal Investigator
Naval Medical Research Center

Media Library

Melatonin Group Clinical Trial Eligibility Overview. Trial Name: NCT04953754 — N/A
Vaccine Response Research Study Groups: Melatonin Group, Control Group
Vaccine Response Clinical Trial 2023: Melatonin Group Highlights & Side Effects. Trial Name: NCT04953754 — N/A
Melatonin Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT04953754 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have been enlisted in this research effort?

"Affirmative. asserts that this trial, which first opened on October 25th 2022, is currently recruiting participants. A total of 200 patients are needed from a single clinical site."

Answered by AI

For whom is entry into this research project open?

"This medical trial is searching for 200 individuals, aged 18 to 64 years old with circadian rhythm disturbances. It is imperative that participants are eligible to receive the flu vaccine at a military hospital and have DEERS eligibility."

Answered by AI

Is recruitment currently open for this investigation?

" attests that this medical trial is open for patient enrolment, with the initial listing on October 25th 2022 and a recent update posted one day prior."

Answered by AI

Does this investigation stipulate a minimum age to participate?

"Eligibility for this trial is exclusive to those aged 18-64. For individuals under the age of 18, there are 33 different clinical trials available and 103 more options exist for patients older than 65 years old."

Answered by AI

Who else is applying?

What state do they live in?
What site did they apply to?
Naval Support Activity
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
~104 spots leftby Oct 2024