NCT06334510

Evaluate the Safety and Efficacy of Quadrivalent Influenza in Real-world Situations.

Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,900 (actual)
• Sponsor: Hualan Biological Bacterin Co. Ltd. · Industry
• Sex: All
• Age: 3 Years – 74 Years
• Healthy volunteers: Accepted

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 4900).were 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 ≥2.5 times 30 days after any dose of vaccination, the vaccination schedule was considered to have acceptable immunogenicity. Safety outcome MEASURES The occurrence of adverse reactions/events after each dose of vaccination was observed. The incidence of ① total adverse reactions/events, ② incidence of grade 3 or above adverse reactions/events and SAE, ③ incidence of adverse reactions/events severity classification, ④ incidence of adverse reactions/events by type (inoculation site and systemic, SOC, PT) and incidence of adverse reactions/events 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, irritation/inhibition, acute anaphylaxis, and fatigue/fatigue.

Conditions

• GCP

Interventions

Type	Name	Description
BIOLOGICAL	One dose of quadrivalent influenza virus split vaccine was administered	Safety observation: All 4900 vaccine recipients participated in the safety observation after vaccination, and were followed up for adverse events (AE) within 30 minutes and 0-30 days after vaccination, and SAEs within 6 months after vaccination. In addition to 1050 recipients aged 18-59 years who were included in the first layer test, 350 recipients aged 3-17 years and 350 recipients aged ≥60 years were randomly selected from each group. Blood samples were collected before and 30 days after vaccination for influenza virus HI antibody detection.

Timeline

• Start date: 2021-11-17
• Primary completion: 2023-01-20
• Completion: 2023-03-28
• First posted: 2024-03-28
• Last updated: 2024-03-28

Locations

1 site across 1 country: China