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Vaccine
Influenza Vaccine for Social Behavior (BSB Trial)
Phase 4
Recruiting
Led By Keely Muscatell, PhD
Research Sponsored by University of North Carolina, Chapel Hill
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within approximately 24 hours of treatment
Awards & highlights
BSB Trial Summary
This trial will look at how the flu vaccine affects social behavior in people by comparing them with a placebo group.
Who is the study for?
This trial is for healthy students aged 18-35 who have a same-gender friend willing to join them. Participants should not have had the flu vaccine or flu this season, no major medical conditions like diabetes or asthma, no egg allergies, and must not be using mood-altering drugs.Check my eligibility
What is being tested?
The study tests how the influenza vaccine affects social behavior towards strangers and close friends compared to a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real vaccine.See study design
What are the potential side effects?
Potential side effects from the influenza vaccine may include soreness at injection site, mild fever, muscle aches, and feeling tired. These are usually short-lived.
BSB Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within approximately 24 hours of treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within approximately 24 hours of treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in behaviorally coded social engagement between two social targets
Difference in self-reported social connection between two social targets
Difference in unfair monetary offers accepted
BSB Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Influenza VaccineExperimental Treatment1 Intervention
Experimental group given influenza vaccine (Flulaval)
Group II: Sham VaccinePlacebo Group1 Intervention
The control group given a placebo (saline injection)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza vaccine
2014
Completed Phase 4
~5650
Find a Location
Who is running the clinical trial?
University of North Carolina, Chapel HillLead Sponsor
1,504 Previous Clinical Trials
4,187,562 Total Patients Enrolled
24 Trials studying Inflammation
5,282 Patients Enrolled for Inflammation
U.S. National Science FoundationFED
34 Previous Clinical Trials
8,774 Total Patients Enrolled
1 Trials studying Inflammation
200 Patients Enrolled for Inflammation
Keely Muscatell, PhDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill
2 Previous Clinical Trials
138 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have reported all my major medical conditions.I have a history of or currently experience depression or anxiety.I have received this year's flu vaccine or had the flu already.I am between 18 and 35 years old.I am not willing to show my face during social tasks.I am currently experiencing symptoms of an illness, such as a cold or flu.I have had COVID-19 in the last two weeks.I have had Guillain-Barre Syndrome.I weigh less than 110 pounds.I am taking medication that affects my mood or immune system.I have a friend of the same gender who will join the second study session with me.I am not willing to be recorded during social tasks.
Research Study Groups:
This trial has the following groups:- Group 1: Influenza Vaccine
- Group 2: Sham Vaccine
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is eligibility for this research trial restricted to individuals under 30 years of age?
"The eligibility criteria for this medical trial necessitates that participants must be above the age of consent and below 35 years old."
Answered by AI
Is enrollment currently available for this research project?
"This medical trial is actively enrolling patients, as indicated by the information available on clinicaltrials.gov. The study was first posted to this platform on October 17th 2022 and underwent its most recent update on December 8th of the same year."
Answered by AI
For which types of individuals is this trial most suitable?
"This study requires a cohort of 100 psychologically and sociologically able adults aged eighteen to thirty-five. In addition, these participants must have an individual from the same gender willing to participate in the second trial session."
Answered by AI
What is the total enrollment capacity of this investigation?
"Affirmative. The information held on clinicaltrials.gov suggests that this trial is actively seeking participants, with the original post appearing on October 17th 2022 and a recent update occurring December 8th 2022. A total of 100 patients need to be recruited from one medical centre."
Answered by AI
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