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NCT03614975 · ClinicalTrials.gov registry record · Phase 4
Immunologic Response to Influenza Vaccination in Children and Adolescents
A Phase 4 study, sponsored by Richard Zimmerman MD.
- Completed
- Registry status
- Phase 4
- Development phase
- 166
- Enrollment target
NCT03614975: Completed Phase 4 study, sponsored by Richard Zimmerman MD.
NCT03614975 is a Phase 4 study that has completed, run by Richard Zimmerman MD. The registered enrollment target is 166 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03614975, a Phase 4 study, has completed, sponsored by Richard Zimmerman MD.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 166 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccination to Flucelvax (egg-free inactivated flu shot) and Fluzone (egg-based inactivated flu shot).
Primary Outcome
Hemagglutination inhibition (HI) assay will be 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.
Interventions
- BIOLOGICAL Flucelvax inactivated influenza vaccine
- BIOLOGICAL Fluzone inactivated influenza vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 166 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2018-12-13 |
| Phase | Phase 4 |
What the finished NCT03614975 record still lists
NCT03614975 is an interventional study that assigns participants to a tested intervention. The registered 166 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 2 interventions - of which Flucelvax inactivated influenza vaccine is the first listed.
NCT03614975 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03614975 about?
NCT03614975 is a clinical study titled "Immunologic Response to Influenza Vaccination in Children and Adolescents". The purpose of this study is to evaluate immunologic response to different types of influenza vaccine among children/adolescents/young adults 4-20 years of age. This is a randomized controlled trial (RCT), that will assess immune response in 120 participants (60 per vaccine arm) pre- and post-vaccin...
What is the current status of trial NCT03614975?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 166 participants. The study started on 2018-09-13. Estimated completion is 2018-12-13.
What interventions are being tested in trial NCT03614975?
The interventions under investigation include: Flucelvax inactivated influenza vaccine (BIOLOGICAL), Fluzone inactivated influenza vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03614975?
This trial is sponsored by Richard Zimmerman MD, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03614975's enrollment target sits among peer trials
166 489th of 2000 higher than 1,509 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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