The study will evaluate the safety, tolerability, and immunogenicity of 2 dose levels of IN006 in healthy participants who aged at 60 years or older; of a revaccination of IN006 given 12 months or 24 months after the initial vaccination.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
500
Formulation for injection
0.9% sodium chloride (normal saline) injection
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Percentage of Participants With Solicited Local and Systemic Adverse Reactions Through 14 Days After Initial Vaccination
Time frame: From initial vaccination up to14 days post initial vaccination
Percentage of Participants With Unsolicited Adverse Events (AEs) Through 28 Days After Initial Vaccination
Time frame: From initial vaccination up to 28 days post initial vaccination
Percentage of Participants With Unsolicited AEs Through 30 Minutes After Initial Vaccination
Time frame: From initial vaccination up to 30 minutes post initial vaccination
Percentage of Participants With Any Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) During Study
Time frame: Through study completion, about 3 years at most
Percentage of Abnormal Results of Hematology On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to 3 days post initial vaccination
Percentage of Abnormal Results of Clinical Chemistry On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to 3 days post initial vaccination
Percentage of Abnormal Results of Coagulation On Day 3 After Initial Vaccination Compared with Baseline
Time frame: From initial vaccination up to 3 days post initial vaccination
Percentage of Participants With Any AEs Leading to Discontinuation of Vaccination or Withdrawal From The Study
Time frame: Through study completion, about 3 years at most
Geometric mean concentration (GMC) for Pre-F Specific IgG Antibody Against RSV A and RSV B
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Time frame: 1 month post-initial vaccination
Geometric Mean Fold Rise (GMFR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
Seroconversion Rate (SCR) for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
Geometric mean titer (GMT) for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
GMFR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
SCR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 1 month post-initial vaccination
GMC for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMFR for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
SCR for Pre-F Specific IgG Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMT for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
GMFR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination
SCR for Neutralizing Antibody Against RSV A and RSV B
Time frame: 3, 6 and 12 months post-initial vaccination