This study is a randomized, blinded, parallel-controlled phase 3 clinical trial. The study intent to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (LVRNA009) as heterologous booster in participants aged 18 years and older vaccinated 2 doses Inactivated SARS-CoV-2 Vaccine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
1,100
50μg /0.5 mL/Vial/person
0.5 mL/Vial, 0.5mL per human dose containing 600SU of inactivated SARS-CoV-2 antigen
Clinical Trial Unit, National Institute of Health
Islamabad, Pakistan
Geometric mean titer (GMT) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 14 days after vaccination for all participants
Seroconversion Rate (SCR) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Seroconversion is defined as: GMT post vaccination≥ 4-fold rise from baseline GMT value
Time frame: 14 days after vaccination for all participants
Incidence of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Intensity of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Duration of each solicited (local and systemic) AE and each unsolicited AE
Time frame: AE within 14 days, unsolicited AE within 28 days after vaccination for all participants
Geometric mean increase (GMI) of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 14 days after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
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GMI of SARS-CoV-2 (Wild-type strain) VNA (live virus neutralizing assay)
Time frame: 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of SARS-CoV-2 (Wild-type strain) VNA (pseudo-virus neutralizing assay)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMT of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
SCR of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
GMI of S-protein specific IgG antibodies (ELISA)
Time frame: 14 days, 28 days, 3 months, 6 months, and 12 months after vaccination for all participants
Incidence of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants
Intensity of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants
Causality of serious adverse events (SAEs), adverse events of special interest (AESI), and the occurrence of pregnancy events
Time frame: within 12 months after vaccination for all participants