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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03058692
The ClinicalTrials.gov registry entry for NCT03058692 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03058692 reports 0 study locations.
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.
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