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

NCT06334510 | Completed

• 1 other identifier: HL-SJLG-2021-Ⅳ-01
• Study Type: observational
• Target: 4,900
• Locations: 1 country
• Sites: 1

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‰.

Conditions

GCP

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and immunogenicity of Hualan Biovar quadrivalent influenza vaccine in a larger population in the real world, and to observe rare adverse drug reaction (ADR) of 1‰.

  The incidence of adverse events/reactions after quadrivalent influenza vaccination was observed, and the incidence of ① total adverse events/reactions, ② incidence of grade 3 or above adverse events/reactions and SAE, ③ incidence of adverse events/reactions according to severity classification of adverse events/reactions and ④ incidence of symptomatic adverse events/reactions were calculated.

  The safety was observed until 6 months after the full course of immunization

Secondary Outcomes (1)

• To explore the consistency of three consecutive batches of commercial vaccines for vaccination in adults aged 18-59 years.

  Before and 30 days after immunization

Study Arms (2)

Approval consistency study

A total of 1050 recipients aged 18-59 years were enrolled in this study. Blood samples were collected before and 30 days after vaccination. Hemagglutination inhibition (HI) antibody to influenza virus was detected in the serum of all recipients to evaluate the inter-batch consistency of the vaccine.

Biological: One dose of quadrivalent influenza virus split vaccine was administered

Safety and immunogenicity in a larger vaccination cohort aged 3 years and older

3850 recipients were enrolled in an open trial: safety observation after vaccination, follow-up for adverse events (AE) 30 minutes and 0-30 days after vaccination, and SAEs for 6 months after vaccination.

Biological: One dose of quadrivalent influenza virus split vaccine was administered

Interventions

One dose of quadrivalent influenza virus split vaccine was administered BIOLOGICAL

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.

Approval consistency study; Safety and immunogenicity in a larger vaccination cohort aged 3 years and older

Eligibility Criteria

• Age: 3 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Healthy people aged 3 years and older

You may qualify if:

• Healthy people aged 3 years and above;
• I (or/and his/her legal guardian/authorized representative) can comply with the requirements of the clinical trial protocol after informed consent and voluntary signed informed consent;
• No contraindications of quadrivalent influenza vaccine in the package insert and meet the vaccination requirements after medical history inquiry.

You may not qualify if:

• Allergy to any component of the quadrivalent influenza vaccine, including egg, excipients, formaldehyde, or Triton X-100;
• people with a history of anaphylaxis after vaccination (allergy to any previous vaccination);
• Acute disease, severe chronic disease, acute onset of chronic disease, cold and fever;
• Axillary body temperature ≥37.3℃ (\> 14 years old) and ≥37.5℃ (≤14 years old) before vaccination;
• Uncontrolled epilepsy;
• patients with progressive neurological disease or a history of Guillain-Barre syndrome;
• receiving immunoglobulin injection for less than one month;
• vaccination with live attenuated vaccine within 14 days before and other vaccines within 7 days before vaccination;

Sponsors & Collaborators

• Hualan Biological Bacterin Co. Ltd.: lead

Study Sites (1)

Kou Zengqiang

Jinan, Shandong, 250000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Approximately 3ml of blood was collected before and 30 days after immunization

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: November 17, 2021
• Primary Completion: January 20, 2023
• Study Completion: March 28, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

CN (1)