Protective Efficacy , Immunogenicity and Safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell).
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-71
SponsorSinovac Biotech Co., Ltd
About this trial
This multicenter, randomized, double-blind, placebo-controlled phase IIIa clinical trial aims to evaluate the protective efficacy , immunogenicity and safety of the Tetravalent Inactivated Enterovirus Vaccine (Vero Cell) in Children aged 6 to 71 months.
Participants will be randomly assigned in a 1:1 ratio to the trial group and the placebo group, receiving two doses of experimental vaccine or placebo , with a one-month interval between the two doses.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy children aged 6 to 71 months.
Guardians who can understand and voluntarily sign the informed consent form
Willing and able to comply with all visit schedules, sample collection, vaccinations, and other trial procedures。
Provide legal identification for the participant and their guardian
Disqualifiers
A known history of HFMD/HA
Uncontrolled chronic diseases or a history of severe illnesses, including but not limited to cardiovascular diseases, blood disorders, liver or kidney diseases, digestive system diseases, respiratory system diseases, malignant tumors, or a history of major functional organ transplantation.
Autoimmune diseases, immunodeficiency diseases (including but not limited to systemic lupus erythematosus, ankylosing spondylitis, autoimmune thyroid diseases, asplenia, functional asplenia, and HIV infection).
Abnormal coagulation function (such as coagulation factor deficiencies,and platelet abnormalities).
Trial design
Design model
Parallel
Treatments tested in this trial
Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)
Biological/VaccineTwo doses are administered with a one-month interval between each dose.
Placebo
Biological/VaccineTwo doses are administered with a one-month interval between each dose.
Treatment groups
6,000 Participants
are divided into 2 treatment groupsGroup A: Tetravalent Inactivated Enterovirus Vaccine (Vero Cell)Experimental treatment 1 intervention
Group B: placeboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by any serotype of EV71, CA16, CA10 and CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by any serotype of EV71, CA16, CA10 and CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
Time frame
From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)2
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA6 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA6 in children aged 6 to 71 months starting from Day 15 after full-course vaccination during the primary protective efficacy analysis stage.
Time frame
From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)From day 15 after the full-course vaccination to data cutoff date of primary analysis3
Evaluate the protective efficacy of the investigational vaccine against HFMD caused by CA16 infection compared to placebo.
Evaluate the protective efficacy of the investigational vaccine versus placebo against RT-PCR-confirmed primary HFMD caused by CA16 in children aged 6 to 71 months starting from Day 15 after full-course immunization during the primary protective efficacy analysis stage.
Time frame
From day 15 after full-course vaccination to the data cutoff date when the pre-specified number of primary HFMD cases is reached (case-driven primary analysis)Secondary outcomes
1
Evaluate the safety of the investigational vaccine
Incidence of adverse reactions within 0-30 days after each dose of investigational vaccine
Time frame
From day 0 to day 30 after vaccination (The day of vaccination is defined as Day 0)2
Evaluate the safety of the investigational vaccine
Incidence of serious adverse events (SAEs) from the start of vaccination until 6 months after the full vaccination.
Time frame
From day of vaccination to 6 months after vaccination3
Evaluate the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seroconversion rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at day 30 after full-course vaccination
Time frame
At day 30 after full-course vaccination4
Evaluate the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6
Assess the seropositivity rate of neutralizing antibodies against EV71, CA16, CA10, CA6 at day 30 after full-course vaccination
Time frame
At day 30 after full-course vaccinationOther outcomes
1
Evaluate the protective efficacy of the investigational vaccine compared to placebo against diseases caused by infections with other untyped enteroviruses excluding EV71, CA16, CA10 and CA6 .
Evaluate the protective efficacy of the investigational vaccine compared to placebo against RT-PCR-confirmed diseases caused by infections with other untyped enteroviruses excluding EV71, CA16, CA10 and CA6 in children aged 6 to 71 months, from Day 15 after full-course immunization until the end of two consecutive epidemic seasons.
Time frame
From day 15 after full-course vaccination to the end of case surveillance period (December 31, 2027)2
Evaluate the seroconversion rate of neutralizing antibodies against different subtype strains
Assess the seroconversion rate of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame
Day 30 after full-course vaccination3
Evaluate the seropositivity rate of neutralizing antibodies against different subtype strains
Assess the seropositivity rate of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame
Day 30 after full-course vaccination4
Evaluate the GMT of neutralizing antibodies against different subtype strains
Assess the GMT of neutralizing antibodies against different subtype strains at 30 days after full-course vaccination
Time frame
Day 30 after full-course vaccinationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: