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NCT04636697 · ClinicalTrials.gov registry record · Phase 2
Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults
A Phase 2 study of SARS CoV 2 Infection, sponsored by Medicago.
- Active
- Registry status
- Phase 2
- Development phase
- 30,918
- Enrollment target
- 20
- Study locations
NCT04636697: Active Phase 2 study of SARS CoV 2 Infection, sponsored by Medicago.
NCT04636697 is a Phase 2 study of SARS CoV 2 Infection that is active but no longer recruiting, run by Medicago. The registered enrollment target is 30,918 participants, above the 3,304-participant average among 35 other SARS CoV 2 Infection trials with a reported enrollment target (836% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04636697, a Phase 2 study of SARS CoV 2 Infection, is active but no longer recruiting, sponsored by Medicago.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 30,918 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and safety of the CoVLP formulation compared to placebo. Subjects will be followed for safety and immunogenicity for a period of 12 months after the last vaccination.
Primary Outcome
Percentage, intensity, and relationship to vaccination of immediate AEs
Conditions Studied
Interventions
- DRUG Intramuscular injection
- BIOLOGICAL Intramuscular vaccine
Study Locations (20)
California
- Hope Clinical Research - Canoga Park
- CNS Network - Garden Grove
- Long Beach Clinical Trial Services Inc. - Long Beach
- Pharmacology Research Institute - Newport Beach
- Wr-McCr, Llc - San Diego
Florida
- Alliance for Multispecialty Research - Coral Gables
- Research Centers of America - Hollywood
- AppleMed Research Inc - Miami
- Elixia COVID-19 - Palm Beach
- Precision Clinical Research - Sunrise
Alabama
- Achieve Clinical Research, LLC dba Accel Research Sites - Birmingham
Arizona
- Fiel Family and Sports Medicine/CCT - Tempe
District of Columbia
- Ascension Providence Health System - Washington D.C.
Georgia
- Meridian Clinical Research - Savannah
Idaho
- ASR, LLC - Nampa
Illinois
- Affinity Health - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30,918 participants |
| Start Date | 2020-11-19 |
| Est. Completion | 2022-04-30 |
| Phase | Phase 2 |
What the registry record for NCT04636697 still lists
NCT04636697 is an interventional study that assigns participants to a tested intervention. Its 30,918 participants enrollment target places it among the larger protocols in the corpus, above the 3,304-participant average among 35 other SARS CoV 2 Infection trials with a reported enrollment target (836% higher).
The record links to 1 condition, with SARS CoV 2 Infection appearing as the primary indexed condition, and to 2 interventions - of which Intramuscular injection is the first listed.
NCT04636697 names 20 study sites across 12 states, led by California, Florida, Alabama.
Frequently Asked Questions
What is clinical trial NCT04636697 about?
NCT04636697 is a clinical study titled "Study of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults". This Phase 2/3 study is a multi-portion design to confirm that the chosen formulation and dosing regimen of CoVLP has an acceptable immunogenicity and safety profile. The Phase 3 portion is an event-driven, randomized, observer blinded, placebo-controlled design that will evaluate the efficacy and ...
What is the current status of trial NCT04636697?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30,918 participants. The study started on 2020-11-19. Estimated completion is 2022-04-30.
What conditions does trial NCT04636697 study?
This clinical trial studies the following conditions: SARS CoV 2 Infection.
What interventions are being tested in trial NCT04636697?
The interventions under investigation include: Intramuscular injection (DRUG), Intramuscular vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04636697?
This trial is sponsored by Medicago, which has 9 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04636697 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04636697's enrollment target sits among peer trials
30,918 2nd of 35 the highest of 35 other SARS CoV 2 Infection trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other SARS CoV 2 Infection 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.
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