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NCT03300050 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine
A Phase 1 study, sponsored by PATH.
- Completed
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
NCT03300050: Completed Phase 1 study, sponsored by PATH.
NCT03300050 is a Phase 1 study that has completed, run by PATH. The registered enrollment target is 65 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03300050, a Phase 1 study, has completed, sponsored by PATH.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
Study Summary
The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.
Primary Outcome
Solicited adverse events were assessed by study staff for 60 minutes after each vaccination and and then by study participants daily for 7 days on a a diary card. Solicited local reactions included: * Post LAIV dose: nasal congestion, rhinorrhea; * Post IIV dose: pain, redness, swelling.
Interventions
- BIOLOGICAL cH8/1N1 LAIV
- BIOLOGICAL AS03-adjuvanted cH5/1N1 IIV
- BIOLOGICAL cH5/1N1 IIV
- BIOLOGICAL AS03-adjuvanted cH8/1N1 IIV
- BIOLOGICAL Normal saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2019-08-09 |
| Phase | Phase 1 |
What the finished NCT03300050 record still lists
NCT03300050 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which cH8/1N1 LAIV is the first listed.
NCT03300050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03300050 about?
NCT03300050 is a clinical study titled "Safety and Immunogenicity of a Live-attenuated Universal Flu Vaccine Followed by an Inactivated Universal Flu Vaccine". The clinical study will evaluate safety and the immune response of a prime- boost regimen with a live attenuated influenza vaccine (LAIV) prime and an inactivated split influenza vaccine (IIV) boost with or without adjuvant.
What is the current status of trial NCT03300050?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2017-10-10. Estimated completion is 2019-08-09.
What interventions are being tested in trial NCT03300050?
The interventions under investigation include: cH8/1N1 LAIV (BIOLOGICAL), AS03-adjuvanted cH5/1N1 IIV (BIOLOGICAL), cH5/1N1 IIV (BIOLOGICAL), AS03-adjuvanted cH8/1N1 IIV (BIOLOGICAL), Normal saline (BIOLOGICAL).
Who is sponsoring clinical trial NCT03300050?
This trial is sponsored by PATH, which has 18 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03300050's enrollment target sits among peer trials
65 798th of 2000 higher than 1,193 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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