Influenza
Conditions
Keywords
Quadrivalent influenza virus split vaccine, MDCK cells, Safety, Immunogenicity
Brief summary
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.
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.
Interventions
BIOLOGICALQuadrivalent influenza virus split vaccine (MDCK cells)
Quadrivalent influenza vaccine made from cell matrix (0.5ml/dose).
BIOLOGICALQuadrivalent influenza virus split vaccine (Chicken embryo)
Quadrivalent influenza vaccine made from chicken embryo(0.5ml/dose).
Phosphate buffer solution without vaccine antigen(0.5ml/dose).
Sponsors
Shaanxi Provincial Center for Disease Control and Prevention
Shanghai Institute Of Biological Products
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This is a single center, randomized, double-blind, controlled phase I clinical trial.
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
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
（
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Solicited Adverse Events (AEs) | 7 days after each dose of vaccination | Adverse events defined by the protocol that occurred to the participant during 0-7 days after each dose of vaccination. |
| Unsolicited Adverse Events | 28 or 30 days after each dose of vaccination | Other adverse events that occurred among participants within 0-28/30 days after each vaccination, in addition to the solicited adverse events. |
| Serious Adverse Events (SAE) | 6 months after the last dose | That is serious adverse events, any serious adverse events that occurred to the participant during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 30 days after the last dose of vaccination | 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. |
| Ratio of ≥1:40 | 30 days after the last dose of vaccination | 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. |
| Geometric mean increase (GMI) | 30 days after the last dose of vaccination | 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. |
Countries
China
Outcome results
None listed