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Sing2016 M2SR H3N2 Vaccine for Flu
Phase 1
Waitlist Available
Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participant is a male or female child aged 6 months to 17 years inclusive at time of enrollment
A female participant of child-bearing potential agrees to abstain from sexual intercourse or to correctly use an acceptable method of contraception
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through day 395
Awards & highlights
Study Summary
This trial is designed to assess the safety and immunogenicity of of one and two doses of Sing2016 M2SR H3N2 influenza vaccine (manufactured by FluGen) administered intranasally in seven cohorts of children.
Who is the study for?
Children aged 6 months to 17 years, in good health, can join this trial. Specific age ranges apply for different cohorts. Participants must not have received certain vaccines or treatments recently and should not be planning to join other clinical trials during the study period. Girls of childbearing potential and sexually active boys must agree to use contraception.Check my eligibility
What is being tested?
The trial is testing the safety and immune response of one or two doses of Sing2016 M2SR H3N2 influenza vaccine given intranasally compared with a placebo in children across seven age-specific groups. The dosage varies by cohort, with reviews by a Safety Review Committee after initial follow-ups.See study design
What are the potential side effects?
Potential side effects are likely similar to those from other nasal flu vaccines, which may include nasal congestion, runny nose, sore throat, headache, fatigue, and fever. As it's a Phase 1b trial focused on safety and tolerability/reactogenicity assessment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 months and 17 years old.
Select...
I agree to use birth control or abstain from sex.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 through day 395
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 through day 395
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Adverse Events of Special Interest (AESIs)
Occurrence of New-onset Chronic Medical Conditions (NOCMCs)
Occurrence of Serious Adverse Event (SAEs)
+2 moreSecondary outcome measures
Geometric Mean Fold Rise (GMFR) in serum Hemagglutination inhibition (HAI) antibody titers
Geometric Mean Fold Rise (GMFR) in serum neutralization titers
Geometric Mean Titers (GMTs) in serum neutralizing antibodies
+7 moreTrial Design
4Treatment groups
Experimental Treatment
Group I: Cohort 4Experimental Treatment2 Interventions
Once, there is sufficient evidence of safety and tolerability in Cohort 3 and enrollment has been completed for this cohort, and fifth cohorts (Cohorts 4 and 5) will begin enrollment. A cohort of influenza non-naïve 25 healthy children, 2-8 years old, will receive two doses of the 10^9 TCID50 of intranasal Sing2016 M2SR H3N2 vaccine (N=15) or two doses of placebo (N=10) at Day 1 and Day 29. N=25
Group II: Cohort 3Experimental Treatment2 Interventions
Once, there is sufficient evidence of safety and tolerability in Cohorts 1 and 2,and enrollment has completed of all 45 in each of these cohorts. Cohort 3 will begin enrollment. A cohort of influenza non-naïve 25 healthy children, 2-8 years old, will receive a single dose of 10^9 TCID50 of intranasal Sing2016 M2SR H3N2 vaccine (N=15) or placebo (N=10) at Day 1. N=25.
Group III: Cohort 2Experimental Treatment2 Interventions
A cohort of influenza non-naïve 45 healthy children, 2-8 years old, will receive a single dose of 10^8 TCID50 of intranasal Sing2016 M2SR H3N2 vaccine (N=30) or placebo (N=15) at Day 1 intranasally. N= 45
Group IV: Cohort 1Experimental Treatment2 Interventions
A cohort of influenza non-naïve 45 healthy children, 9-17 years old, will receive a single dose of 10^9 TCID50 of intranasal Sing2016 M2SR H3N2 vaccine (N=30) or placebo (N=15) at Day 1. N=45.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,329 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have received or plan to receive a flu shot around my study vaccinations.I am a woman who can still have children and have not been sterilized.I have a history of frequent sinus infections.I have not taken antiviral drugs a week before or after getting a trial vaccine.I haven't had a live vaccine 30 days before or plan to within 30 days after the study vaccine.I have never received a flu shot and have never been diagnosed with the flu.I have had the flu or taken flu medicine in the last 4 months.You have a history of smoking or currently smoke or vape.I have a history of nasal or nasopharynx disorders.Depending on the group, you need to be between certain ages to participate in the study. Also, for some groups, you must have received at least 2 doses of the seasonal flu vaccine in the past.You are a female of child-bearing potential who agrees to abstain from sexual intercourse or to correctly use an acceptable method of contraception.I have not used and do not plan to use aspirin or salicylate products around the time I receive the trial vaccine.You had a bad reaction after getting a flu shot before.I will use condoms as contraception during the study and for 60 days after.I haven't had any non-flu vaccines 14 days before or plan to within 30 days after the study vaccine.I haven't received blood products or immunoglobulin in the last 6 months.I am a child aged between 6 months and 17 years.I am using or will use effective birth control before and after vaccination.I haven't used any experimental treatments or devices in the last 6 months.I am between 6 months and 17 years old.I haven't taken any COVID-19 treatment or prevention drugs in the last 10 days.You have HIV, hepatitis B, or hepatitis C infection.I have received at least 2 flu shots in the past.I (or my child) can follow the study plan and attend all visits.I am a woman who can have children and have a recent negative pregnancy test.I agree to use contraception during and for 60 days after the study.I am currently immunosuppressed due to illness or treatment.I haven't had a fever or been sick in the last 3 days.I do not have any health conditions that would make this study unsafe for me.I have asthma diagnosed by a doctor and have used medication for it within the last year.I have used steroids in the past 30 days.I have had Guillain-Barré syndrome in the past.I agree to use birth control or abstain from sex.I have been diagnosed with or have a history of cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 4
- Group 2: Cohort 1
- Group 3: Cohort 2
- Group 4: Cohort 3
Awards:
This trial has 0 awards, including: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.
Does the age limit for this trial extend to individuals over 60 years old?
"Children as young as 6 months and adults up to age 17 can enroll in this trial, which is one of 38 similar trials for minors and 78 for seniors."
Answered by AI
Is there a heightened risk associated with the Sing2016 M2SR H3N2 virus?
"Sing2016 M2SR H3N2 received a score of 1 for safety because it is only in Phase 1 trials. This means that there is limited data supporting both safety and efficacy."
Answered by AI
Does this clinical trial have a presence in several hospitals across North America?
"There are a few locations across America where this trial is enrolling patients. For example, University of Iowa - Infectious disease Clinic in Iowa City, Iowa, Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center in Nashville, Tennessee, and University of Maryland School of Medicine - Center for Vaccine Development - Baltimore in Baltimore, Maryland."
Answered by AI
Who else is applying?
What state do they live in?
Maryland
How old are they?
18 - 65
What site did they apply to?
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
What portion of applicants met pre-screening criteria?
Met criteria
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