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NCT01147068 · 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
- 392
- Enrollment target
NCT01147068: Completed Phase 1 study, sponsored by Protein Sciences Corporation.
NCT01147068 is a Phase 1 study that has completed, run by Protein Sciences Corporation. The registered enrollment target is 392 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (553% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01147068, a Phase 1 study, has completed, sponsored by Protein Sciences Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 392 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 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.
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 non-adjuvanted rHA and placebo groups for whether they demonstrated seroconversion rates and 95% confidence intervals that met regulatory criterion for licensure.
Interventions
- BIOLOGICAL 0.5mL Intramuscular Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 392 participants |
| Start Date | 2010-06 |
| Est. Completion | 2011-10 |
| Phase | Phase 1 |
What the finished NCT01147068 record still lists
NCT01147068 is an interventional study that assigns participants to a tested intervention. The registered 392 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 (553% higher).
The record links to 0 conditions, and to 1 intervention - of which 0.5mL Intramuscular Injection is the first listed.
NCT01147068 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01147068 about?
NCT01147068 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 4 dose levels in adjuvanted (GLA-SE) rHA formulations and 2 dose levels in unadjuvanted rHA formulations.
What is the current status of trial NCT01147068?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 392 participants. The study started on 2010-06. Estimated completion is 2011-10.
What interventions are being tested in trial NCT01147068?
The interventions under investigation include: 0.5mL Intramuscular Injection (BIOLOGICAL).
Who is sponsoring clinical trial NCT01147068?
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 NCT01147068's enrollment target sits among peer trials
392 77th of 2000 higher than 1,923 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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