This was a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population. After randomization, the trial for each participant lasted for approximately 13 months. Screening period was 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo were given intramuscularly (IM) separated by 21 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
960
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, China
SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)
SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.
Time frame: 1 Month after Dose 2
The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2
Time frame: 1 Month after Dose 2
SARS-CoV-2 serum neutralizing titers - SCR
Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
Time frame: 1 Week, 6 and 12 Months after Dose 2
SARS-CoV-2 serum neutralizing titers - GMT
GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
Time frame: 1 Week, 6 and 12 Months after Dose 2
SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR
Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Time frame: 1 Week, 1, 6 and 12 Months after Dose 2
SARS-CoV-2 anti-S1 IgG antibody level - GMT
GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Time frame: 1 Week, 1, 6 and 12 Months after Dose 2
SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)
Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.
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Time frame: 1 Week, 1, 6 and 12 Months after Dose 2
SARS-CoV-2 anti-S1 IgG antibody level - GMFR
Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
Time frame: 1 Week, 1, 6 and 12 Months after Dose 2
Percentage of participants reporting local reactions
Pain at the injection site, redness, and swelling as self-reported on diary cards.
Time frame: Within 7 Days and 14 Days after each vaccination
Percentage of participants reporting systemic events
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.
Time frame: Within 7 Days and 14 Days after each vaccination
Hematology laboratory assessments
Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
Time frame: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
Chemistry laboratory assessments
Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
Time frame: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
Hematology laboratory assessments
Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
Time frame: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
Chemistry laboratory assessments
Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
Time frame: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
Adverse events (AEs)
AEs from dose 1 to 1 month after the last dose.
Time frame: From Dose 1 through 1 Month after the last Dose
Serious AEs (SAEs)
SAEs from dose 1 to 6 months after the last dose.
Time frame: From Dose 1 through 6 Months after the last Dose