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NCT04368988 · ClinicalTrials.gov registry record · Phase 1
Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant
A Phase 1 study, sponsored by Novavax.
- Completed
- Registry status
- Phase 1
- Development phase
- 1,419
- Enrollment target
NCT04368988 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 1,419 participants.
The verdict
NCT04368988, a Phase 1 study, has completed, sponsored by Novavax.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1,419 participants
- Enrollment target
Study Summary
2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) years of age at 2 sites in Australia. An interim analysis of Part 1 safety and immunogenicity will be performed prior to optional expansion to Part 2. Part 2 (Phase 2) of the study is designed to evaluate the immunogenicity, safety, and preliminary efficacy of a single construct of SARS-CoV-2 rS nanoparticle vaccine with Matrix-M adjuvant in up to 1,500 healthy participants ≥ 18 to 84 (inclusive) years of age at up to 40 sites across Australia and/or the United States.
Interventions
- BIOLOGICAL SARS-CoV-2 rS - Phase 1
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1
- OTHER Normal saline solution (NSS), Placebo - Phase 1
- OTHER Normal saline solution (NSS), Placebo - Phase 2
- BIOLOGICAL SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,419 participants |
| Start Date | 2020-05-25 |
| Est. Completion | 2022-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04368988
The ClinicalTrials.gov registry entry for NCT04368988 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 1,419 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novavax, which has 31 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which SARS-CoV-2 rS - Phase 1 is the first listed.
NCT04368988 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04368988 about?
NCT04368988 is a clinical study titled "Evaluation of the Safety and Immunogenicity of a SARS-CoV-2 rS Nanoparticle Vaccine With/Without Matrix-M Adjuvant". 2019nCoV-101 is a 2-part, randomized, observer-blinded, placebo-controlled, Phase 1/2 trial. Part 1 (Phase 1) of the study is designed to evaluate the safety and immunogenicity of SARS-CoV-2 rS nanoparticle vaccine with or without Matrix-M adjuvant in 131 healthy participants ≥ 18 to 59 (inclusive) ...
What is the current status of trial NCT04368988?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 1,419 participants. The study started on 2020-05-25. Estimated completion is 2022-06-01.
What interventions are being tested in trial NCT04368988?
The interventions under investigation include: SARS-CoV-2 rS - Phase 1 (BIOLOGICAL), SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1 (BIOLOGICAL), Normal saline solution (NSS), Placebo - Phase 1 (OTHER), Normal saline solution (NSS), Placebo - Phase 2 (OTHER), SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04368988?
This trial is sponsored by Novavax, which has 31 total clinical trials registered on ClinicalTrials.gov.
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