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NCT01612000 · ClinicalTrials.gov registry record · Phase 1
Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults
A Phase 1 study, sponsored by Protein Sciences Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 341
- Enrollment target
NCT01612000: Completed Phase 1 study, sponsored by Protein Sciences Corporation.
NCT01612000 is a Phase 1 study that has completed, run by Protein Sciences Corporation. The registered enrollment target is 341 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (468% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01612000, a Phase 1 study, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 341 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/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
Primary Outcome
Immunogenicity was assessed by measuring the percentage of subjects in each group exhibiting seroconversion on Day 42. The treatment groups that received adjuvanted rHA were evaluated against a non-adjuvanted rHA treatment group for whether they demonstrated seroconversion rates and 95% confidence intervals.
Interventions
- BIOLOGICAL rHA adjuvant
- BIOLOGICAL PanBlok
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 341 participants |
| Start Date | 2012-05 |
| Est. Completion | 2013-12 |
| Phase | Phase 1 |
What the finished NCT01612000 record still lists
NCT01612000 is an interventional study that assigns participants to a tested intervention. The registered 341 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 (468% higher).
The record links to 0 conditions, and to 2 interventions - of which rHA adjuvant is the first listed.
NCT01612000 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01612000 about?
NCT01612000 is a clinical study titled "Safety and Immunogenicity of PanBlok Influenza Vaccine in Healthy Adults". The purpose of this study is to investigate the safety and immunogenicity of a recombinant hemagglutinin (rHA) influenza vaccine derived from A/Indonesia/05/2005 (H5N1) administered at 3 dose levels in adjuvanted (SE) rHA formulations and 1 dose levels in an un-adjuvanted rHA formulation.
What is the current status of trial NCT01612000?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 341 participants. The study started on 2012-05. Estimated completion is 2013-12.
What interventions are being tested in trial NCT01612000?
The interventions under investigation include: rHA adjuvant (BIOLOGICAL), PanBlok (BIOLOGICAL).
Who is sponsoring clinical trial NCT01612000?
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 NCT01612000's enrollment target sits among peer trials
341 104th of 2000 higher than 1,897 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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