Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Novavax.
NCT04368988 is a Phase 1 study that has completed, run by Novavax. The registered enrollment target is 1,419 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2265% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Percentage of participants with solicited AEs (local, systemic) for 7 days following each primary vaccination (Days 0, 21) by severity score, duration, and peak intensity.
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 |
What the finished NCT04368988 record still lists
NCT04368988 is an interventional study that assigns participants to a tested intervention. Its 1,419 participants enrollment target places it among the larger protocols in the corpus, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (2265% higher).
The record links to 0 conditions, and to 5 interventions - of which SARS-CoV-2 rS - Phase 1 is the first listed.
NCT04368988 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04368988's enrollment target sits among peer trials
1,419 3rd of 2000 higher than 1,998 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05890404 · 1,410 participants · NA
SGM Evidenced-Based Mental Healthcare Implementation
- NCT07042451 · 1,410 participants · NA
An Evaluation of the Pink Cloud Application in Post- Treatment Substance Use Disorder Support
- NCT07222566 · 1,410 participants · Phase 3
A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- NCT05992935 · 1,405 participants · Phase 1
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1403 and mRNA-1405 to Prevent Norovirus Acute Gastroenteritis in Healthy Adults 18 to 80 Years of Age
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI