NCT05975060Phase 2, phase 3Completed

A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants.

Study sponsor: Novavax

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2023-11-15Actual

Enrollment · participants660Actual

Source updated2024-05-30Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

COVID-19

Treatments or interventions studied

XBB.1.5 Vaccine (Booster)BiologicalAlso known as Omicron sub variant XBB.1.5 vaccine( booster) SARS-CoV-2 rS /Matrix-M Adjuvant
XBB.1.5 Vaccine (single dose)BiologicalAlso known as Omicron sub variant XBB.1.5 vaccine(single dose) SARS-CoV-2 rS /Matrix-M Adjuvant

Primary outcomes · main study measures

Read the study measures

measure: Part 1: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine; description: Pseudovirus neutralization (inhibitory dilution at a concentration of 50%; ID 50 ) to the NVX-CoV2601 vaccine assessed at Day 28 following study vaccination.; timeFrame: Day 28; measure: Part 1: Seroresponse Rates (SRRs) in ID 50 titers to the NVXCoV2601 vaccine; description: SRRs (proportion of seroconverted participants) in ID 50 titers to the NVXCoV2601 vaccine assessed at Day 28 following the study vaccination.; timeFrame: Day 28; measure: Part 2: SRRs in ID 50 titers to the XBB.1.5 Omicron subvariant; description: SRRs (proportion of seroconverted participants) in ID 50 titers to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.; timeFrame: Day 28; measure: Part 2: ID 50 (Geometric Mean Titers) GMTs to the XBB.1.5 Omicron subvariant; description: ID 50 GMTs to the XBB.1.5 Omicron subvariant assessed at Day 28 following study vaccination.; timeFrame: Day 28

History coverage

Imported research includes version dates later than the current official API record (2024-05-30). Disputed observations are retained for audit and excluded from trusted change feeds and sponsor statistics. Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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