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NCT03982069 · ClinicalTrials.gov registry record · Phase 4
Immunologic Response to FluMist vs. Flucelvax
A Phase 4 study of Influenza, Human and Immune Response, sponsored by Richard Zimmerman MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 465
- Enrollment target
- 2
- Study locations
NCT03982069: Completed Phase 4 study of Influenza, Human and Immune Response, sponsored by Richard Zimmerman MD.
NCT03982069 is a Phase 4 study of Influenza, Human and Immune Response that has completed, run by Richard Zimmerman MD. The registered enrollment target is 465 participants, below the 16,198-participant average among 18 other Influenza, Human trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03982069, a Phase 4 study of Influenza, Human and Immune Response, has completed, sponsored by Richard Zimmerman MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 465 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- and post-vaccination to FluMist (live attenuated influenza vaccine given by nasal administration) and Flucelvax (egg-free cell-culture inactivated influenza vaccine).
Primary Outcome
Rows in data tables represent different influenza antigens measured in 2019. Hemagglutination inhibition (HI) assay was conducted to assess immunologic outcome. Seroconversion is defined as a 4-fold or higher rise in HI titer post-vaccination given a pre-vaccination HI titer of \>=10 and a final HI titer of \>=40.
Conditions Studied
Interventions
- BIOLOGICAL FluMist live attenuated influenza vaccine
- BIOLOGICAL Flucelvax inactivated influenza vaccine
Study Locations (2)
Pennsylvania
- General Academic Pediatrics - Pittsburgh
- University of Pittsburgh Department of Family Medicine - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 465 participants |
| Start Date | 2019-09-20 |
| Est. Completion | 2020-12-09 |
| Phase | Phase 4 |
What the finished NCT03982069 record still lists
NCT03982069 is an interventional study that assigns participants to a tested intervention. The registered 465 participants enrollment target is mid-sized for trials with a published cap, below the 16,198-participant average among 18 other Influenza, Human trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Influenza, Human appearing as the primary indexed condition, and to 2 interventions - of which FluMist live attenuated influenza vaccine is the first listed.
NCT03982069 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03982069 about?
NCT03982069 is a clinical study titled "Immunologic Response to FluMist vs. Flucelvax". The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-21 years of age. This is a randomized controlled trial (RCT), that will assess immune response in about 440 participants (about 220 per vaccine arm) pre- an...
What is the current status of trial NCT03982069?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 465 participants. The study started on 2019-09-20. Estimated completion is 2020-12-09.
What conditions does trial NCT03982069 study?
This clinical trial studies the following conditions: Influenza, Human, Immune Response.
What interventions are being tested in trial NCT03982069?
The interventions under investigation include: FluMist live attenuated influenza vaccine (BIOLOGICAL), Flucelvax inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03982069?
This trial is sponsored by Richard Zimmerman MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03982069 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT03982069's enrollment target sits among peer trials
465 11th of 18 higher than 8 of 18 other Influenza, Human trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Influenza, Human 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.
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