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NCT04439695 · ClinicalTrials.gov registry record · Phase 1

Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults

A Phase 1 study, sponsored by KBio.

Completed
Registry status
Phase 1
Development phase
120
Enrollment target

NCT04439695: Completed Phase 1 study, sponsored by KBio.

NCT04439695 is a Phase 1 study that has completed, run by KBio. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04439695, a Phase 1 study, has completed, sponsored by KBio.

COMPLETED
Registry status
Phase 1
Development phase
120 participants
Enrollment target

Study Summary

This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.

Primary Outcome

Occurrences of Adverse Events

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL Low dose
  • BIOLOGICAL Intermediate dose
  • BIOLOGICAL High dose

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2020-06-25
Est. Completion 2021-07-28
Phase Phase 1
KBio

4 total trials

What the finished NCT04439695 record still lists

NCT04439695 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT04439695 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04439695 about?

NCT04439695 is a clinical study titled "Study to Evaluate the Safety and Immunogenicity of KBP-V001 Quadrivalent Influenza Vaccine in Healthy Adults". This is an observer-blinded, randomized, placebo-controlled, parallel group study to evaluate safety and immunogenicity of TAP-V001 quadrivalent influenza vaccine in healthy adult subjects.

What is the current status of trial NCT04439695?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2020-06-25. Estimated completion is 2021-07-28.

What interventions are being tested in trial NCT04439695?

The interventions under investigation include: Placebo (BIOLOGICAL), Low dose (BIOLOGICAL), Intermediate dose (BIOLOGICAL), High dose (BIOLOGICAL).

Who is sponsoring clinical trial NCT04439695?

This trial is sponsored by KBio, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04439695's enrollment target sits among peer trials

120 479th of 2000 higher than 1,503 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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Source: ClinicalTrials.gov NCT04439695, the US trial registry maintained by the National Library of Medicine. NCT04439695 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.