Clinical trial
Phase IV Clinical Study on Safety and Efficacy of Quadrivalent Influenza Virus Split Vaccine in Larger Population
Name
HL-SJLG-2021-Ⅳ-01
Description
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‰.
Trial arms
Trial start
2021-11-17
Estimated PCD
2023-01-20
Trial end
2023-03-28
Status
Completed
Treatment
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.
Arms:
Approval consistency study, Safety and immunogenicity in a larger vaccination cohort aged 3 years and older
Size
4900
Primary endpoint
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 safety was observed until 6 months after the full course of immunization
Eligibility criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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;
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Approximately 3ml of blood was collected before and 30 days after immunization'}, 'enrollmentInfo': {'count': 4900, 'type': 'ACTUAL'}}
Updated at
2024-03-28
1 organization
1 product
1 indication
Indication
GCPOrganization
Hualan Biological Bacterin