A Clinical Trial of Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

A Randomized, Double-blind, Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of the Quadrivalent Influenza Virus Split Vaccine (MDCK Cells) for Individuals Aged 6 Months and Above.

To evaluate the safety of administering 1 or 2 doses of the quadrivalent influenza virus split vaccine (MDCK cells) (0.5ml/dose) in individuals aged 6 months and above.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: Quadrivalent influenza virus split vaccine (MDCK cells); Biological: Quadrivalent influenza virus split vaccine (Chicken embryo); Other: Phosphate buffer solution

Detailed Description

This is a single center, randomized, double-blind, controlled phase I clinical trial. Plan to include 300 participants aged 6 months and above. The experiment was divided into 5 age groups, with 60 cases each aged 6-35 months, 3-8 years, 9-17 years, 18-59 years, and ≥ 60 years old. Each age group was randomly assigned to the experimental group, control group, or placebo group in a 1:1:1 ratio. Among them, the participants aged 6 to 35 months and 3 to 8 years old will receive 2 doses throughout the entire process, with an interval of 28 days between each dose. Participants aged 9-17, 18-59, and ≥ 60 years old are vaccinated with one dose throughout the entire process.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanxi, China
    • Shanxi Provincial Center for Disease Prevention and Control

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy individuals aged 6 months or more on the day of enrollment who can provide legal identification documents.
• Volunteers and/or their legal guardians (or entrusted persons) have informed consent, voluntarily participate, and sign an informed consent form.
• Volunteers and/or their legal guardians (or entrusted persons) have the ability (non-illiterate) to understand the research procedures, could use thermometers, scales, and fill out diary cards as required, and can comply with the requirements of the clinical trial protocol to complete the clinical study.

Exclusion Criteria:

（Exclusion criteria for the first dose）

• On the day of enrollment, the underarm temperature of individuals ≤ 14 years old is ≥ 37.5 ℃, and on the day of enrollment, the underarm temperature of individuals>14 years old is ≥ 37.3 ℃.
• Women of childbearing age (from menarche to menopause for ≤ 1 year) who have tested positive for urinary pregnancy test, and those who are breastfeeding, pregnant, or planning to conceive within 6 months.
• Have had or are currently suffering from influenza within the past 3 months (confirmed by clinical, serological, or microbiological methods).
• Individuals aged 6 months to 8 years have previously received any influenza vaccine (including registered or experimental) or have planned to receive any influenza vaccine during the study period. Individuals aged 9 and above have received any influenza vaccine (including registered or experimental) within the past 6 months or have planned to receive any influenza vaccine within the past 6 months.

Has a history of allergic reactions to any component of the research vaccine, including consuming eggs or using gentamicin sulfate.

• Has any history of severe allergies to vaccines or drugs in the past. Population aged 6 to 35 months: premature birth (delivered before the 37th week of pregnancy), low birth weight (birth weight<2500g) infants.
• Population aged 6 to 35 months: those with a history of difficult childbirth, suffocation rescue, and neurological damage.
• Congenital malformations (clinically significant according to researchers) or developmental disorders, genetic defects, and severe malnutrition.
• Population aged 3-8 years and 6-35 months: individuals with abnormal growth and development, severe eczema.
• Suffering from acute illness or being in the acute phase of chronic illness within 3 days before vaccination.
• Used antipyretic and analgesic drugs or anti allergic drugs within 3 days before vaccination.
• Suffering from serious chronic diseases, serious cardiovascular diseases, hypertension beyond drug control (systolic pressure ≥ 140mmHg or diastolic pressure ≥ 90mmHg, only applicable to people aged 18 and above), diabetes with complications, liver and kidney diseases, malignant tumors, etc.
• Have a history of receiving attenuated live vaccines within 14 days (including the 14th day) before vaccination and have a history of receiving other vaccines within 7 days (including the 7th day).
• Individuals who receive immunotherapy or immunosuppressive therapy within 3 months (continuous oral or intravenous for more than 14 days).
• Suffering from congenital or acquired immunodeficiency, human immunodeficiency virus infection, lymphoma, leukemia, or other autoimmune diseases.
• Asthma history, unstable in the past two years requiring emergency treatment, hospitalization, intubation, oral or intravenous corticosteroids.
• Have received blood or blood related products within the past 6 months.
• Individuals with progressive neurological disorders have a history of seizures, epilepsy, encephalopathy, Guillain Barre syndrome, psychiatric disorders, transverse myelitis, or family history.
• Have a history of abnormal coagulation function (such as coagulation factor deficiency, coagulation related diseases), or use anticoagulants within 3 weeks before vaccination.
• Non splenic, functional non splenic, splenectomy, or partial resection of other important organs.
• Plan to relocate before the end of the study or leave the local area for a long time during the scheduled study visit period.
• Being or planning to participate in other clinical trials in the near future.
• Abnormal laboratory testing indicators, except for minor abnormalities judged by doctors to have no clinical significance.
• The researcher determines any situation that is not suitable for participation in this clinical trial.

（Exclusion criteria for the second dose）

• On the day of vaccination, the axillary body temperature is ≥ 37.5 ℃.
• Fever (axillary temperature ≥ 38.5 ℃) within 3 days before vaccination, or use of antipyretic and analgesic drugs or anti allergic drugs within 3 days before vaccination.
• Suffering from various acute or chronic diseases with acute attacks within 3 days before vaccination.
• Insufficient interval between vaccination of other vaccines (with a history of receiving attenuated live vaccines within 14 days (including the 14th day) before vaccination, and a history of receiving other vaccines within 7 days (including the 7th day).
• Other situations where researchers believe vaccination should be postponed.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SIBP-V03-I; Quadrivalent influenza virus split vaccine (MDCK cells)	Biological: Quadrivalent influenza virus split vaccine (MDCK cells); Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).
Active Comparator: QTV (chicken embryo); Quadrivalent influenza virus split vaccine (chicken embryo)	Biological: Quadrivalent influenza virus split vaccine (Chicken embryo); Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).
Placebo Comparator: Placebo; Phosphate buffer solution	Other: Phosphate buffer solution; Phosphate buffer solution without vaccine antigen(0.5ml/dose).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Solicited Adverse Events (AEs)	Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination.	7 days after each dose of vaccination
Unsolicited Adverse Events	Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events.	28 or 30 days after each dose of vaccination
Serious Adverse Events (SAE)	That is serious adverse events, any serious adverse events that occurred to the participant during the study period.	6 months after the last dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate	30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the HI antibody seroconversion rate against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.	30 days after the last dose of vaccination
Ratio of ≥1:40	30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, the ratio of HI antibody titers ≥ 1:40 against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.	30 days after the last dose of vaccination
Geometric mean increase (GMI)	30 days after the full vaccination of all participants with the experimental vaccine or control vaccine, GMI of HI antibodies against any subtype of influenza virus in the experimental vaccine group and the control vaccine group.	30 days after the last dose of vaccination

Collaborators and Investigators

• Sponsor: Shanghai Institute Of Biological Products
• Collaborators: Shaanxi Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Guohua Li, 0351-7553168

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: March 26, 2024
• First Posted (Actual): April 2, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 16, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Immunogenicity; Quadrivalent influenza virus split vaccine; MDCK cells
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Influenza, Human; Immunologic Factors; Physiological Effects of Drugs; Vaccines
• Other Study ID Numbers: SIBP-V03-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No