Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-28 @ 7:23 AM
Study NCT ID:
NCT06800950
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-01-30
First Post:
2025-01-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase III Clinical Trial of Quadrivalent Influenza Virus Split Vaccine
Sponsor:
Institute of Medical Biology, Chinese Academy of Medical Sciences
Organization:
Study Overview
Official Title:
A Randomized, Blinded, Positive-controlled Phase III Clinical Trial of Quadrivalent Influenza Vaccine (split Virion) in People Aged 3 Years and Above
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
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 III clinical trial to evaluate the immunogenicity and safety of the Quadrivalent Influenza Virus Split Vaccine (QIV) in subjects (aged 3 years and above). Primary 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, and primary safety endpoints are the occurrence of safety events after vaccination including the incidence of adverse events/adverse reactions within 30 minutes/7 days/30 days after immunization, as well as the incidence of serious adverse events/adverse relations within 6 months which will be defined as the secondary safety endpoint. Besides, the secondary endpoints are to evaluate the same index above in different administration programs in children aged 3-8 years.
Detailed Description:
This is a randomized, blinded, active-controlled phase III clinical trial to evaluate the immunogenicity and safety in 4400 subjects (aged 3 years and above). Then 1760 children (aged 3-8 years), 1320 adults/adolescents (aged 9-59 years), and 1320 elders (aged 60 years and above) are eligible for enrollment after assessing the medical history and physical examination.
1760 children's strata contains 1320 children with no history of influenza vaccine and 440 children with a history of influenza vaccine. Those 1320 children to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 440 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 440 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The rest of the 440 children with a history of influenza vaccine will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 220 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 adults/adolescents will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 elders will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
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 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.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact 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, urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination.
1760 children's strata contains 1320 children with no history of influenza vaccine and 440 children with a history of influenza vaccine. Those 1320 children to the 2-dose vaccine, 1-dose vaccine, and control group in a ratio of 1:1:1, that is 440 subjects in the 2-dose vaccine cohort will receive 2 doses of experimental vaccines in a 0,28 program, and 440 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine. The rest of the 440 children with a history of influenza vaccine will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 220 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 adults/adolescents will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
1320 elders will be randomly assigned to a 1-dose vaccine and control group in a ratio of 1:1, that is 660 subjects in the 1-dose vaccine or control cohort will receive 1 dose of experimental or active-controlled vaccine.
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 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.
For safety assessment, the observation and evaluation of adverse events from Day 0 to Day 30 after each dose will be conducted by diary/contact 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, urine routine tests or urine pregnancy tests (if applicable) will be performed on Day 0 before vaccination.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: