H3N2 M2SR in Pediatric Population (NCT03553940) | Clinical Trial Compass
CompletedPhase 1
H3N2 M2SR in Pediatric Population
United States43 participantsStarted 2018-08-15
Plain-language summary
This is a Phase I double-blind, randomized, placebo-controlled study in 50 healthy adolescents and children, 9-17 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety and immunogenicity of a prime-boost regimen of H3N2 M2SR intranasal influenza vaccine (manufactured by FluGen) followed by licensed inactivated Quadrivalent Influenza Vaccine (QIV) boost administered intramuscularly Subjects will be enrolled in one of two groups in a 1:1 ratio. Arm 1 will receive one dose of M2SR intranasally on Day 1 and one dose of QIV on Day 92. Arm 2 will receive one dose of placebo (saline) intranasally on Day 1, and one dose of QIV on Day 92. Study duration will be approximately 28 months with patient participation duration approximately 13 months. The primary study objective is to assess the safety and reactogenicity of a monovalent live attenuated influenza H3N2 M2SR vaccine.
Who can participate
Age range
9 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Parent(s)/legal guardian(s) must provide written informed consent prior to initiation of any study procedures, and subject must provide assent.
. Are able to understand and comply with planned study procedures and be available for all study visits.
. Are males or non-pregnant females, 9-17 years old, inclusive at the time of enrollment.
. Are in good health\*.
. Oral temperature is less than 100.0 degrees Fahrenheit.
. For female adolescent of child-bearing potential\* must agree to correctly use an acceptable method of contraception\*\* from 30 days prior to vaccination until 30 days after the last study vaccination.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Adverse Events of Special Interest (AESIs)
Timeframe: Day 1 through Day 92
2
Number of Participants With New Onset Chronic Medical Conditions (NOCMCs)
Timeframe: Day 1 through Day 92
3
Number of Participants With Serious Adverse Events (SAEs)
Timeframe: Day 1 through Day 366
4
Number of Participants With Solicited Reactogenicity
Timeframe: Day 1 through Day 8
5
Number of Participants With Unsolicited Non-Serious Adverse Events
Timeframe: Day 1 through Day 22
Trial details
NCT IDNCT03553940
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
. Female adolescent of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccination.
. Males who are sexually active with a female of childbearing potential must agree not to father a child for 30 days after receipt of the first study vaccination.
Exclusion criteria
. Have an acute illness\*, as determined by the site PI or appropriate sub-investigator, within 72 hours prior to each study vaccination.
. Have any medical disease or condition that, in the opinion of the site PI or appropriate sub-investigator, is a contraindication to study participation\*.
. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy (cytotoxic) within 3 years prior to study vaccination.
. Have known active neoplastic disease or a history of any hematologic malignancy. Non-melanoma skin cancers that are not active are permitted.
. Have known HIV, hepatitis B, or hepatitis C infection.
. Have a history of severe reactions following previous immunization with licensed or unlicensed influenza vaccines.
. History of anatomic disorder of the nares or nasopharynx (Deviated septum is allowed).