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NCT03058692 · ClinicalTrials.gov registry record · Phase 2
Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 120
- Enrollment target
NCT03058692: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT03058692 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 120 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03058692, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 120 participants
- Enrollment target
Study Summary
This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial will be conducted at 3 United States sites and is designed to assess the safety, reactogenicity, and immunogenicity of two priming doses of M-001 followed by a seasonal quadrivalent inactivated influenza vaccine (IIV4). The duration of this trial for each subject will be approximately 7 months. The entire study duration will be approximately 24 months. The primary objectives are: 1) To assess the safety as measured by vaccine related adverse events, reactogenicity, and laboratory adverse events of two doses of M-001 vaccine, each dose administered approximately 21 days apart; and 2) To assess the T cell responses to M-001 component peptides following two doses of M-001.
Primary Outcome
The percentages of CD4 and CD8 T cells expressing markers were determined using fluorescence-based flow cytometric assays from cryopreserved PBMCs collected and isolated from participants at Day 1 prior to initial vaccination and again at 14 days after the second vaccination. The percentages were calculated as the number of cells positive for these proteins divided by the total number of CD4+ or CD8+ T cells counted in each sample.
Interventions
- OTHER Placebo
- BIOLOGICAL Quadrivalent Recombinant Seasonal Influenza Vaccine
- BIOLOGICAL Influenza Multimeric-001 Vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-04-09 |
| Est. Completion | 2019-01-14 |
| Phase | Phase 2 |
What the finished NCT03058692 record still lists
NCT03058692 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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (10% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03058692 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03058692 about?
NCT03058692 is a clinical study titled "Two Doses of Multimeric-001 (M-001) Followed by Influenza Vaccine". This is a Phase II randomized, double-blind, placebo-controlled trial in 120 males and non-pregnant females, 18 to 49 years old, inclusive, who are in good health and meet all eligibility criteria. This clinical trial will be conducted at 3 United States sites and is designed to assess the safety, r...
What is the current status of trial NCT03058692?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 120 participants. The study started on 2018-04-09. Estimated completion is 2019-01-14.
What interventions are being tested in trial NCT03058692?
The interventions under investigation include: Placebo (OTHER), Quadrivalent Recombinant Seasonal Influenza Vaccine (BIOLOGICAL), Influenza Multimeric-001 Vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT03058692?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03058692's enrollment target sits among peer trials
120 569th of 2000 higher than 1,383 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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