This is a multi-center, randomized, blinded, placebo-controlled, phase 3 clinical study to evaluate the efficacy, safety and immunogenicity of SARS-CoV-2 bivalent mRNA vaccine (LVRNA021) as booster in participants aged 18 years and older who completed primary/1 booster dose(s) of SARS-CoV-2 vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
9,800
One dose was administered by intramuscular injection, 100μg,1.0ml/dose
One dose was administered by intramuscular injection, 1.0ml/dose
Sindh Infectious Diseases Hospital & Research Center Dow University of Health Sciences
Islamabad, Pakistan
RECRUITINGPerson-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis occurring from 14 days after booster vaccination.
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed moderate to severe cases of COVID-19 from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed severe cases of COVID-19 from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed cases of COVID-19
The person-year incidence density of first episodes of virologically-confirmed cases of COVID-19 leading to death from 14 days after booster vaccination meeting the case definition for the primary efficacy analysis.
Time frame: 14 days after vaccination or placebo
Person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 for participants in different age strata (18-59 years, ≥ 60 years)
The person-year incidence density of first episodes of virologically-confirmed symptomatic cases of COVID-19 of any severity occurring from 14 days after booster vaccination for participants in different age strata (18-59 years, ≥ 60 years).
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Time frame: 14 days after vaccination or placebo
Incidence of each solicited (local and systemic) AE in all participants.
Incidence of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Time frame: within 14 days after vaccination or placebo
Severity of each solicited (local and systemic) AE in all participants.
Severity of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Time frame: within 14 days after vaccination or placebo
Duration of each solicited (local and systemic) AE in all participants.
Duration of each solicited (local and systemic) AE within 14 days after booster vaccination in all participants.
Time frame: within 14 days after vaccination or placebo
Incidence of unsolicited AEs in all participants.
Incidence of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Time frame: 0-28 days after vaccination or placebo
Severity of unsolicited AEs in all participants.
Severity of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Time frame: 0-28 days after vaccination or placebo
Causality of unsolicited AEs in all participants.
Causality of unsolicited AEs occurring 0-28 days after booster vaccination in all participants.
Time frame: 0-28 days after vaccination or placebo
Incidence of SAEs in all participants.
Incidence of SAEs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of SAEs in all participants.
Severity of SAEs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Incidence of AESIs in all participants.
Incidence of AESIs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of AESIs in all participants.
Severity of AESIs from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Incidence of pregnancy events in all participants.
Incidence of pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Severity of pregnancy events in all participants.
Severity of pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Causality of SAEs, AESIs, and pregnancy events in all participants.
Causality of SAEs, AESIs, and pregnancy events from the day of booster vaccination to 12 months after booster vaccination in all participants.
Time frame: within 12 months after vaccination or placebo
Geometric mean titer (GMT)of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
Seroconversion rate (SCR) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
Geometric mean Increase (GMI) of SARS-CoV-2 (Omicron subvariants) virus neutralizing antibody (live virus neutralizing assay) responses in subjects in the immunization subgroup.
Time frame: 14 days,28 days,3 months and 6 months after vaccination or placebo
GMT of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
GMI of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo
SCR of S-protein IgG antibodies in subjects in the immunization subgroup.
Time frame: 14 days, 28 days,3 months,6 months and 12 months after vaccination or placebo