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NCT01172054 · ClinicalTrials.gov registry record · Phase 1
Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults
A Phase 1 study, sponsored by VaxInnate Corporation.
- Completed
- Registry status
- Phase 1
- Development phase
- 292
- Enrollment target
NCT01172054: Completed Phase 1 study, sponsored by VaxInnate Corporation.
NCT01172054 is a Phase 1 study that has completed, run by VaxInnate Corporation. The registered enrollment target is 292 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (387% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01172054, a Phase 1 study, has completed, sponsored by VaxInnate Corporation.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 292 participants
- Enrollment target
Study Summary
This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
Primary Outcome
Assess safety, reactogenicity and tolerability. Symptoms will be collected from the memory aid and from the information collected at the clinic visits. All symptoms will be graded according to severity. Response to vaccine will be categorized as local (arm pain, redness, bruising etc) or systemic (headache, muscle aches, fatigue, etc) symptoms. Laboratory tests such as CRP, WBC, LFTs and cytokines collected before and after vaccination will also be analyzed. We will compare the types and severit
Interventions
- BIOLOGICAL Placebo
- BIOLOGICAL VAX128
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 292 participants |
| Start Date | 2010-07 |
| Est. Completion | 2011-11 |
| Phase | Phase 1 |
What the finished NCT01172054 record still lists
NCT01172054 is an interventional study that assigns participants to a tested intervention. The registered 292 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 (387% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01172054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01172054 about?
NCT01172054 is a clinical study titled "Comparative Safety and Immunogenicity of VAX128A, VAC128B and VAX128C Novel H1N1 Influenza Vaccine in Healthy Adults". This is a multicenter, escalating dose-ranging study to assess the safety, reactogenicity and immunogenicity of 3 different novel H1N1 influenza vaccine constructs delivered i.m. as a single dose vaccination on day 0.
What is the current status of trial NCT01172054?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 292 participants. The study started on 2010-07. Estimated completion is 2011-11.
What interventions are being tested in trial NCT01172054?
The interventions under investigation include: Placebo (BIOLOGICAL), VAX128 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01172054?
This trial is sponsored by VaxInnate Corporation, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01172054's enrollment target sits among peer trials
292 136th of 2000 higher than 1,864 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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