A Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity
A Multicenter, Randomized, Double-Blind, Controlled, Phase Ⅲ Clinical Trial of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell) in Booster Vaccination to Evaluate Efficacy, Safety and Immunogenicity in Healthy Population Aged 18 Years Old and Above
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
4,950
boost with high dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)
boost with low dose of Recombinant COVID-19 Trivalent (XBB+BA.5+Delta) Protein Vaccine (Sf9 Cell)
boost with Recombinant Variant COVID-19 Vaccine(sf9 cell)
Efficacy against COVID-19
Efficacy against the first occurrence of a virologically confirmed (PCR-positive) case of symptomatic COVID-19, regardless of severity, 14 days after booster vaccination.
Time frame: 14 days after vaccination
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after booster vaccination.
Time frame: 0-7 days after vaccination
Secondary Efficacy against COVID-19
Efficacy against the first occurrence of a virologically confirmed (PCR-positive) case of symptomatic COVID-19 \> 7 days after booster vaccination in subjects, regardless of severity.
Time frame: >7 days after booster vaccination
Secondary Efficacy against COVID-19
Efficacy against first occurrence of virologically confirmed (PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, \> 7 days and \> 14 days after booster vaccination
Time frame: > 7 days and > 14 days after booster vaccination
Secondary Safety
Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days after booster vaccination.
Time frame: 0-30 days after booster vaccination
Secondary Safety
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination.
Time frame: within 12 months after booster vaccination
Secondary Immunogenicity indicator 1
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saline
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 variants (based on the current variants at same time) on day 14, day 30 and 3 months after booster vaccination.
Time frame: day 14, day 30 and 3 months after booster vaccination
Secondary Immunogenicity indicator 2
Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies were measured on day 14, day 30 and 3 months after booster vaccination.
Time frame: day 14, day 30 and 3 months after booster vaccination