The objective of this study is to evaluate the effectiveness of SCTV01E in participants aged ≥18 years.
The study is a randomized, double-blind, placebo-controlled Phase III study. It will evaluate the protective effectiveness and safety of SCTV01E against COVID-19 in participants who were previously received primary series or booster dose of COVID-19 vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
10,000
Guizhou center for disease control and prevention
Guiyang, Guizhou, China
Cases of the first occurrence of symptomatic COVID-19 of any severity starting 7 days (≥8 days) after the study vaccination
After the study vaccination, participants were contacted weekly to inquire about any signs or symptoms related to COVID-19. Participants were encouraged to report any COVID-19-related symptoms they experienced spontaneously during the study period.
Time frame: 7 days after the study vaccination
cases of the first occurrence of all infection, asymptomatic infection, infection with multiple symptoms, moderate, severe, and death due to COVID-19, starting 7-days post-vaccination
Participants were contacted weekly to inquire about any signs or symptoms related to COVID-19. Participants were encouraged to report any COVID-19-related symptoms they experienced spontaneously during the study period.
Time frame: 7 days after the study vaccination
Cases of the first occurrence of all infection, asymptomatic infection, symptomatic infection, infection with multiple symptoms, respectively, starting 14-days post- vaccination.
Participants were contacted weekly to inquire about any signs or symptoms related to COVID-19. Participants were encouraged to report any COVID-19-related symptoms they experienced spontaneously during the study period.
Time frame: 14 days after the study vaccination
Cases of the first occurrence of symptomatic infection, infection with multiple symptoms, moderate, severe and death due to COVID-19, caused by SARS-CoV-2 variants, starting 14-days post-vaccination.
Participants were contacted weekly to inquire about any signs or symptoms related to COVID-19. Participants were encouraged to report any COVID-19-related symptoms they experienced spontaneously during the study period.
Time frame: 14 days after the study vaccination
Immunogenicity: GMT of neutralizing antibody (nAb) against SARS-CoV-2 variants or subvariants on 7, 14, 28, 90, 180 and 365 days post-vaccination
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Blood samples were collected from participants in the immunogenicity subgroup on 0 (pre-injection), 14, and 28 days post-vaccination. Additional blood samples were collected from 200 participants in the immunogenicity subgroup on 7, 90, 180 and 365 days post-vaccination for geometric mean titers (GMTs) of live virus neutralizing antibodies against Omicron BA.5 variant using 50% plaque reduction neutralization test (PRNT50).
Time frame: Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365
Immunogenicity: Seroresponse rate of nAb against SARS-CoV-2 (including its variants and subvariants) on Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365.
the sereresponse rates (SRRs) of nAb (change from \<lower limit of quantification (LLOQ) to ≥4 ×LLOQ, or at least a fourfold rise if baseline ≥LLOQ) compared with the pre-injection baseline (95%CI) against SARS-CoV-2 variants or subvariants
Time frame: Day 0, Day 7, Day 14, Day 28, Day 90, Day 180 and Day 365
Safety: Incidence and severity of solicited AEs of SCTV01E from D0 to D7.
Both active monitoring and spontaneous reporting were used. Solicited AEs within 7 days after the study vaccination were collected through vaccination record cards (VRCs).
Time frame: Day 0 to Day 7 after the study vaccination.
Safety: Incidence and severity of unsolicited AEs of SCTV01E from D0 to D28.
Both active monitoring and spontaneous reporting were used. Unsolicited AEs within 28 days after the study vaccination were collected through vaccination record cards (VRCs).
Time frame: Day 0 to Day 28 after the study vaccination.
Safety: Incidence and severity of SAEs and AESIs from D0 to D365.
Serious adverse events (SAEs) and adverse events of special interest (AESIs) were collected by investigators via phone calls, short messages, e-mails, visits on-site, or other contact methods for up to 365 days.
Time frame: Day 0 to Day 365 after the study vaccination.