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NCT03845231 · ClinicalTrials.gov registry record · Phase 2
Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route
A Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 82
- Enrollment target
- 1
- Study location
NCT03845231: Completed Phase 2 study of Influenza, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03845231 is a Phase 2 study of Influenza that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 82 participants, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03845231, a Phase 2 study of Influenza, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 82 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another. Objective: To compare the body s ability to fight infection when a flu vaccine is given in the nose versus the arm. Eligibility: Healthy, nonsmoking adults ages 18 55. They must be willing to stay in isolation for at least 9 days. They must not have had the flu vaccine since September 1, 2018. Design: Participants must be willing to use birth control or abstinence from visit 1 until 8 weeks after getting the flu virus. Participants will have at least 3 clinic visits over about a month. Visits may include: Medical history Physical exam Blood and urine tests Nasal samples collected Heart and lung function tests At the first visit, participants will get either: Flu vaccine as injection in an arm muscle plus salt water sprays in the nose OR flu vaccine as sprays in the nose plus salt water injection in an arm Within the next few months, participants will stay in an isolation room for at least 9 days. They will be with up to 20 participants. Those who test positive for recreational drugs will leave the study. Participants will: Repeat study tests Answer questions about flu symptoms Have the flu virus sprayed into their nose once Be monitored by a medical team Participants will have at least 2 follow-up visits and repeat study tests.
Primary Outcome
The main focus of the study will be to characterize the mucosal and systemic immunologic correlates of protection from influenza infection in each of the two cohorts.
Conditions Studied
Interventions
- BIOLOGICAL Flucelvax(R)
- OTHER Human Challenge virus
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2019-04-29 |
| Est. Completion | 2020-10-28 |
| Phase | Phase 2 |
What the finished NCT03845231 record still lists
NCT03845231 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 82 participants, a relatively small participant target, below the 36,803-participant average among 156 other Influenza trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Influenza appearing as the primary indexed condition, and to 2 interventions - of which Flucelvax(R) is the first listed.
NCT03845231 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03845231 about?
NCT03845231 is a clinical study titled "Mucosal and Systemic Immunity After Viral Challenge of Healthy Volunteers Vaccinated With Inactivated Influenza Vaccine Via the Intranasal Versus Intramuscular Route". Background: Influenza (flu) is a contagious respiratory virus that makes humans sick. Usually its symptoms are mild, but they can be dangerous. Researchers want to see if one way of giving the flu vaccine is more effective than another. Objective: To compare the body s ability to fight infection ...
What is the current status of trial NCT03845231?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2019-04-29. Estimated completion is 2020-10-28.
What conditions does trial NCT03845231 study?
This clinical trial studies the following conditions: Influenza.
What interventions are being tested in trial NCT03845231?
The interventions under investigation include: Flucelvax(R) (BIOLOGICAL), Human Challenge virus (OTHER).
Who is sponsoring clinical trial NCT03845231?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03845231 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Influenza
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03845231's enrollment target sits among peer trials
82 110th of 156 higher than 47 of 156 other Influenza trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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