Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06622590
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-30
Brief Title:
Phase I Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Randomized Blinded and Positive Controlled Phase Ⅰ Clinical Trial of the Safety and Preliminary Immunogenicity of Quadrivalent Influenza Vaccine split Virion in People Aged 3 Years and Above
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized blinded active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity of the Quadrivalent Influenza Virus Split Vaccine QIV in subjects aged 3 years and above Primary endpoints are the occurrence of safety events after vaccination including the incidence of adverse eventsadverse reactions within 30 minutes7 days30 days after immunization as well as the incidence of serious adverse eventsadverse relations within 6 months which will be defined as the secondary safety endpoint Besides the secondary immunogenicity endpoints are the geometric mean titers geometric mean fold increases seropositive rates and seroconversion rates of anti-influenza virus HI antibodies for all types 30 days after immunization
Detailed Description:
This is a randomized blinded active-controlled phase I clinical trial to evaluate the safety and preliminary immunogenicity in 180 subjects aged 3 years and above Then 40 adults aged 18-59 years 40 elders aged 60 years and above 40 adolescents aged 9-17 years and 60 children aged 3-8 years are eligible for enrollment after assessing through the medical history and physical examination according to the principle of age escalating from adults to children
40 adults in the first stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 11 that is 20 subjects in such group will be injected with the experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to the second stage after putting the record to IRB
40 elders and 40 adolescents in the second stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 11 respectively that is 40 subjects in such group will be injected with the experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to the third stage after putting the record to IRB
60 children in the third stage of the study will be randomly assigned to the 2-dose vaccine 1-dose vaccine and control group in a ratio of 111 that is 20 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 028 program and 20 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to complete the second administration in the 2-dose vaccine cohort after putting the record to IRB
The duration of intervention is no more than 1 month With the 6-month safety monitoring after administration the duration of the study is no more than 7 months
For safety assessment the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diarycontact cards and investigators phone calls Besides the observation and evaluation of serious adverse events up to 6 months after vaccination will be conducted by active reports by subjects legal guardians or investigators phone calls as well as face-to-face visits Meanwhile subjects will be observed at the site for at least 30 minutes after each dose
For laboratory examination blood biochemistry blood routine and urine routine tests or urine pregnancy tests if applicable will be performed on Day 0 before vaccination as well as Day 4 after administration for all subjects
For immunogenicity assessment antibodies against all vaccine-related types of Influenza virus will be assessed in all subjects before vaccination and 30 days after full vaccination
40 adults in the first stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 11 that is 20 subjects in such group will be injected with the experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to the second stage after putting the record to IRB
40 elders and 40 adolescents in the second stage of the study will be randomly assigned to the vaccine and control cohort in a ratio of 11 respectively that is 40 subjects in such group will be injected with the experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to the third stage after putting the record to IRB
60 children in the third stage of the study will be randomly assigned to the 2-dose vaccine 1-dose vaccine and control group in a ratio of 111 that is 20 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 028 program and 20 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine The principal investigator and sponsors will conduct the safety evaluation by assessing the preliminary safety data within 7 days after the injection If the results meet the criterion the study will continue to complete the second administration in the 2-dose vaccine cohort after putting the record to IRB
The duration of intervention is no more than 1 month With the 6-month safety monitoring after administration the duration of the study is no more than 7 months
For safety assessment the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diarycontact cards and investigators phone calls Besides the observation and evaluation of serious adverse events up to 6 months after vaccination will be conducted by active reports by subjects legal guardians or investigators phone calls as well as face-to-face visits Meanwhile subjects will be observed at the site for at least 30 minutes after each dose
For laboratory examination blood biochemistry blood routine and urine routine tests or urine pregnancy tests if applicable will be performed on Day 0 before vaccination as well as Day 4 after administration for all subjects
For immunogenicity assessment antibodies against all vaccine-related types of Influenza virus will be assessed in all subjects before vaccination and 30 days after full vaccination
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None