Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06334510
Status:
COMPLETED
Last Update Posted:
2024-03-28
First Post:
2024-03-13
Brief Title:
Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations
Sponsor:
Hualan Biological Bacterin Co Ltd
Organization:
Hualan Biological Bacterin Co Ltd
Study Overview
Official Title:
Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population
Status:
COMPLETED
Status Verified Date:
2024-03
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:
To evaluate the inter-batch consistency CI of quadrivalent influenza vaccine split virion among healthy people aged 18-59 years Secondly to evaluate the safety and immunogenicity of quadrivalent influenza vaccine split virion in the expanded population aged 3 years and above in order to observe the rare adverse reaction of 1
Detailed Description:
The study was divided into two parts The first part was an inter-batch consistency study a randomized double-blind 1050 subjects aged 18-59 years The second part was the safety and immunogenicity study in the expanded population aged 3 years and above enrollment 4900were selected to receive of normal commercially available quadrivalent influenza vaccine Safety observation follow-up was conducted to observe the occurrence of AE within 30 minutes 0 day and 0-30 days after vaccination and the occurrence of SAE within 6 months after vaccination
Immunogenicity observation Blood samples were collected from all subjects before and 30 days after vaccination for influenza virus HI antibody detection According to the European Union seasonal influenza evaluation criteria if the HI antibody seroconversion rate of each subtype of influenza virus was 40 the HI antibody positive rate was 70 and the GMI of each subtype of influenza virus was 25 times 30 days after any dose of vaccination the vaccination schedule was considered to have acceptable immunogenicity
Safety outcome MEASURES The occurrence of adverse reactionsevents after each dose of vaccination was observed The incidence of ① total adverse reactionsevents ② incidence of grade 3 or above adverse reactionsevents and SAE ③ incidence of adverse reactionsevents severity classification ④ incidence of adverse reactionsevents by type inoculation site and systemic SOC PT and incidence of adverse reactionsevents severity classification were calculated
Note Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows
Inoculation site local adverse events pain induration swelling rash redness pruritus cellulitis
Adverse events at non-inoculated sites systemic included fever diarrhea constipation dysphagia anorexia vomiting nausea myalgia non-inoculated sites arthralgia headache cough dyspnea pruritus at non-inoculated sites without skin lesions mucocutaneous abnormalities irritationinhibition acute anaphylaxis and fatiguefatigue
Immunogenicity observation Blood samples were collected from all subjects before and 30 days after vaccination for influenza virus HI antibody detection According to the European Union seasonal influenza evaluation criteria if the HI antibody seroconversion rate of each subtype of influenza virus was 40 the HI antibody positive rate was 70 and the GMI of each subtype of influenza virus was 25 times 30 days after any dose of vaccination the vaccination schedule was considered to have acceptable immunogenicity
Safety outcome MEASURES The occurrence of adverse reactionsevents after each dose of vaccination was observed The incidence of ① total adverse reactionsevents ② incidence of grade 3 or above adverse reactionsevents and SAE ③ incidence of adverse reactionsevents severity classification ④ incidence of adverse reactionsevents by type inoculation site and systemic SOC PT and incidence of adverse reactionsevents severity classification were calculated
Note Known adverse effects of quadrivalent influenza vaccine that have been identified in previous clinical studies are as follows
Inoculation site local adverse events pain induration swelling rash redness pruritus cellulitis
Adverse events at non-inoculated sites systemic included fever diarrhea constipation dysphagia anorexia vomiting nausea myalgia non-inoculated sites arthralgia headache cough dyspnea pruritus at non-inoculated sites without skin lesions mucocutaneous abnormalities irritationinhibition acute anaphylaxis and fatiguefatigue
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None