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 range9 Years – 17 Years
SexALL
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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.
✓. 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
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)
✕. 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).