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NCT03553940 · ClinicalTrials.gov registry record · Phase 1
H3N2 M2SR in Pediatric Population
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT03553940 is a Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 43 participants.
The verdict
NCT03553940, a Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study 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.
Interventions
- OTHER Placebo
- BIOLOGICAL Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine
- BIOLOGICAL Quadrivalent MDCK Inactivated Influenza Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2018-08-15 |
| Est. Completion | 2020-08-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03553940
The ClinicalTrials.gov registry entry for NCT03553940 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03553940 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03553940 about?
NCT03553940 is a clinical study titled "H3N2 M2SR in Pediatric Population". 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 H3N...
What is the current status of trial NCT03553940?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2018-08-15. Estimated completion is 2020-08-27.
What interventions are being tested in trial NCT03553940?
The interventions under investigation include: Placebo (OTHER), Influenza Virus Monovalent A/H3N2/Bris 10 M2SR Live Vaccine (BIOLOGICAL), Quadrivalent MDCK Inactivated Influenza Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03553940?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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