Trials / Withdrawn
WithdrawnNCT05029856
Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults
A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults
- Status
- Withdrawn
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novavax · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Accepted
Summary
This is a randomized, observer-blinded, Phase 1/2 study with an open-label group to evaluate the safety and immunogenicity of 3 novel SARS-CoV-2 variant vaccine constructs adjuvanted with Matrix-M1 adjuvant. Investigational products will include a monovalent SII SARS-CoV-2 B.1.351 (Beta) variant vaccine (SII B.1.351), a bivalent SII vaccine containing antigen for both the ancestral strain and B.1.351 (Beta) variant of SARS-CoV-2 (SII Bivalent), and a monovalent SII SARS-CoV-2 B.1.617.2 (Delta) variant vaccine (SII B.1.617.2).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SII B.1.351 | Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant, 1 or 2 doses:1 on Day 0 and ± 1 on Day 21. |
| BIOLOGICAL | SII B.1.351 | Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant, 1 or 2 doses:1 on Day 0 and ± 1 on Day 21. |
| BIOLOGICAL | SII Bivalent | Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21. |
| BIOLOGICAL | SII Bivalent | Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21. |
| BIOLOGICAL | SII B.1.617.2 | Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant, 1 or 2 doses:1 on Day 0 and ± 1 on Day 21. |
Timeline
- Start date
- 2022-02-04
- Primary completion
- 2022-08-01
- Completion
- 2022-08-01
- First posted
- 2021-09-01
- Last updated
- 2022-05-31
Locations
4 sites across 1 country: Australia
Source: ClinicalTrials.gov record NCT05029856. Inclusion in this directory is not an endorsement.