This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages.Phase 1 and Phase 2
This trial is a randomized, blind, similar vaccine controlled, single center, non-inferiority design phase III clinical trial, with a study population of 10 to 60 years old, conducted in two stages. Phase 1: 40 adult subjects aged 18-60 were randomly assigned to receive the trial vaccine in a 1:1 ratio according to a 5-dose immunization program (0, 3, 7, 14, 28 days) or a 4-dose immunization program (0, 7, 21 days (2 doses for the first dose). The number of recipients for each immunization program was 20. All subjects in the adult group underwent a preliminary safety assessment 7 days after the first dose of vaccination (before the third dose of vaccine), but did not meet the suspension/termination criteria. A further 40 underage subjects aged 10-17 were enrolled in the same order as the adult group, and all subjects underwent a preliminary safety assessment 7 days after the full dose of vaccination. If they did not meet the suspension/termination criteria, they entered the second phase of the study. Phase 2: A total of 1800 subjects aged 10 to 60 years old were randomly assigned to three groups in a 1:1:1 ratio, namely the 5-dose experimental group (vaccinated with the 5-dose program), the 5-dose control group (vaccinated with the 5-dose program), and the 4-dose experimental group (vaccinated with the 4-dose program). All subjects collected blood samples before the first dose, 7 days after the first dose, 14 days after the first dose, and 14 days after the entire dose for immunogenicity evaluation; Subjects who meet the requirements for immune persistence observation in the plan shall collect blood samples 3 months after the full vaccination, and the experimental group subjects shall also collect blood samples 12 months after the full vaccination for immune persistence evaluation. Collect all AEs from participants within 30 minutes after each dose, collected AEs within 0-7 days after each dose (if the interval from the current dose to the next dose is less than 7 days, the collection period shall be based on the actual interval between the two doses), all non collected AEs within 30 days after the first dose to the entire dose, and all serious adverse events (SAE) within 6 months after the first dose to the entire dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,880
Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: up to 14 days after the first/full dose of vaccination
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: 14 days after the first/full dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of any local and systemic adverse events (AEs)
Time frame: within 30 minutes after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of collected AEs
Time frame: within 0-7 days after each dose of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of non solicited AE
Time frame: within 30 days after the first dose of vaccination to the full course of vaccination
Incidence of Adverse Events [Safety and Tolerability]
The incidence of all serious adverse events (SAE)
Time frame: within 6 months after the first dose administration and the entire vaccination process
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity conversion rates in the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
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Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
Time frame: 7 days after the first dose of vaccination;3 month after full dose of vaccination;
Geometric mean concentration - Immunogenicity endpoint
GMC of the 4-dose experimental group, 5-dose experimental group, and 5-dose control group
Time frame: 7 days after the first dose of vaccination;3 month after full dose of vaccination;
Antibody positive conversion rate - Immunogenicity endpoint
Antibody positivity in the 5-dose and 4-dose test groups
Time frame: 12 month after full dose of vaccination;
Geometric mean concentration - Immunogenicity endpoint
GMC of the 5-dose and 4-dose test groups
Time frame: 12 month after full dose of vaccination;