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NCT05975060: COVID-19
A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.
Phase 2, PHASE3 trial testing XBB.1.5 Vaccine (Booster) in COVID-19 in 660 participants. Completed in 20 May 2024.
15 November 2023
Quick facts
| Lead sponsor | Novavax |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 660 |
| Start date | 7 September 2023 |
| Primary completion | 15 November 2023 |
| Estimated completion | 20 May 2024 |
| Sites | 30 locations across United States |
Drugs / interventions tested
- XBB.1.5 Vaccine (Booster) — full drug profile →
- XBB.1.5 Vaccine (single dose) — full drug profile →
Conditions studied
- COVID-19 — all drugs for COVID-19 →
Sponsor
Novavax — full company profile →
Who can join
Adults 18 to 54, any sex, with COVID-19. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 2/3 open-label study to evaluate the safety and immunogenicity of a booster dose of the XBB.1.5 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) recombinant (r) spike (S) protein nanoparticle vaccine (SARS-CoV-2 rS) adjuvanted with Matrix-M™ in previously mRNA COVID-19 vaccinated adult participants ≥18 years of age and baseline SARS CoV-2 seropositive COVID-19 vaccine naïve participants ≥18 years of age.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Comprehensive Review of COVID-19: Epidemiology, Pathogenesis, Advancement in Diagnostic and Detection Techniques, and Post-Pandemic Treatment Strategies.
Chung YS, Lam CY, Tan PH, Tsang HF, et al · · 2024 · cited 48× · PMID 39125722 · DOI 10.3390/ijms25158155 -
Immunogenicity and safety of a monovalent omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose in US adults: interim analysis of a single-arm phase 2/3 study.
Alves K, Kotloff K, McClelland RS, Kouassi A, et al · · 2025 · cited 8× · PMID 39824198 · DOI 10.1016/s1473-3099(24)00670-4 -
Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: Primary day-28 analysis of a phase 2/3 open-label study.
Alves K, Kouassi A, Plested JS, Kalkeri R, et al · · 2025 · cited 2× · PMID 40184816 · DOI 10.1016/j.vaccine.2025.127046 -
Immunogenicity and safety of a monovalent Omicron XBB.1.5 SARS-CoV-2 recombinant spike protein vaccine in previously unvaccinated, SARS-CoV-2 seropositive participants: primary day-28 analysis of a phase 2/3 open-label study
Alves K, Kouassi A, Plested JS, Kalkeri R, et al · · 2024 · cited 2× · DOI 10.1101/2024.10.25.24316129 -
Safety and immunogenicity of four sequential doses of NVX-CoV2373 in adults and adolescents: A phase 3, randomized, placebo-controlled trial (PREVENT-19).
Áñez G, McGarry A, Woo W, Kotloff KL, et al · · 2025 · cited 1× · PMID 40479932 · DOI 10.1016/j.vaccine.2025.127362 -
Phase 2/3 open-label study on NVX-CoV-2601 (XBB.1.5) vaccine in previously COVID-19 mRNA vaccinated and vaccine-naive participants: a 6-month follow-up
Alves K, Kotloff K, McClelland RS, Hammershaimb EA, et al · · 2025 · DOI 10.1101/2025.04.09.25325550
Verify or expand the search:
- PubMed search for NCT05975060
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for COVID-19
Currently open trials in the same condition.
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- NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
- NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
- NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
- NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting
Other Novavax trials
Trials by the same sponsor.
- NCT07086222 — Efficacy and Safety of NVX-CoV2705 · Phase 4 · not yet recruiting
- NCT06482359 — Lot Consistency Study of COVID-19 and Influenza Combination Vaccine · Phase 2, PHASE3 · withdrawn
- NCT06291857 — A Study to Evaluate the Safety and Immunogenicity of COVID-19 Vaccine and Influenza Combination Vaccine · Phase 3 · active not recruiting
- NCT06409663 — A Strain Change Study for SARS-CoV-2 rS Vaccines · Phase 3 · completed
- NCT06633835 — Impact of Reactogenicity of the 2024-2025 COVID-19 Vaccines on Health Care Workers and First Responders in the United St · Phase 4 · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05975060 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Novavax
- Last refreshed: 30 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05975060.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing