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NCT02464163 · ClinicalTrials.gov registry record · Phase 1
Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older
A Phase 1 study, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 407
- Enrollment target
NCT02464163: Completed Phase 1 study, sponsored by Protein Sciences Corporation.
NCT02464163 is a Phase 1 study that has completed, run by Protein Sciences Corporation. The registered enrollment target is 407 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (578% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464163, a Phase 1 study, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 407 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
Primary Outcome
The primary endpoint will be "seroprotection rate" to the selected dose of adjuvanted H7 rHA, defined by a post-vaccination HAI titer ≥40 on Day 42. The definition of success will be a lower bound of the two-sided 95% CI ≥ 70% for adults \<65 and ≥60% for adults ≥65 years of age.
Interventions
- BIOLOGICAL Panblok
- BIOLOGICAL rHA adjuvant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2015-07 |
| Est. Completion | 2016-08 |
| Phase | Phase 1 |
What the finished NCT02464163 record still lists
NCT02464163 is an interventional study that assigns participants to a tested intervention. The registered 407 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 (578% higher).
The record links to 0 conditions, and to 2 interventions - of which Panblok is the first listed.
NCT02464163 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02464163 about?
NCT02464163 is a clinical study titled "Trial to Evaluate the Immunogenicity and Safety of Panblok® (H7 rHA) in Healthy Adults Aged 18 and Older". The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Anhui/1/2013 (H7N9) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an unadjuvanted rHA formulation.
What is the current status of trial NCT02464163?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 407 participants. The study started on 2015-07. Estimated completion is 2016-08.
What interventions are being tested in trial NCT02464163?
The interventions under investigation include: Panblok (BIOLOGICAL), rHA adjuvant (BIOLOGICAL).
Who is sponsoring clinical trial NCT02464163?
This trial is sponsored by Protein Sciences Corporation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02464163's enrollment target sits among peer trials
407 74th of 2000 higher than 1,927 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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