NCT05188677

Immunogenicity and Safety Study of SCB-2019 Vaccine as a Booster to COVID-19 Vaccine in Adults

A Multi-center, Observer-blind, Randomized, Controlled Phase 3 Study to Evaluate the Immunogenicity and Safety of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019), Administered as a Booster Dose to Adults, Who Previously Received Primary Series of a COVID-19 Vaccine

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,831 (actual)
• Sponsor: Clover Biopharmaceuticals AUS Pty · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who: * Received primary series with one of the selected authorized or investigational COVID-19 vaccines at least 3 months prior to enrollment. * Received primary series and a booster dose of CoronaVac at least 3 months prior to enrollment.

Conditions

• COVID-19

Interventions

Type	Name	Description
BIOLOGICAL	Candidate vaccine, SCB-2019	a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
BIOLOGICAL	Comirnaty Vaccine	intramuscular injection
BIOLOGICAL	Vaxzevria Vaccine	intramuscular injection
BIOLOGICAL	CoronaVac Vaccine	intramuscular injection

Timeline

• Start date: 2022-06-13
• Primary completion: 2023-06-06
• Completion: 2023-06-06
• First posted: 2022-01-12
• Last updated: 2023-08-24

Locations

2 sites across 1 country: Philippines