Healthy
Conditions
Keywords
Inactivated split influenza vaccine, Immunogenicity, Safety, Consistence
Brief summary
The objective of this study was to evaluate the safety and immunogenicity of one inactivated split influenza vaccine, a primarily Chinese-marketed trivalent vaccine.
Detailed description
A total of 3308 subjects were stratified equally into four age groups and receive either influenza vaccine or recombinant hepatitis b vaccine (seen as placebo). Systematic and local adverse reactions were reported for 28 d after the vaccination. Antibody levels were detected through hemagglutination inhibition assay before vaccination (Baseline) and 28d after the vaccination.
Interventions
BIOLOGICALrecombinant hepatitis b vaccine
0.5ml intramuscular
BIOLOGICALAleph influenza vaccine
0.5ml intramuscular
Sponsors
Beijing Center for Disease Control and Prevention
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* more than three years in good healthy
Exclusion criteria
* current infectious fever or acute disease * upper respiratory infectious symptom within 6m * a history of allergy * laboratory confirmed influenza * autoimmune disease * have get influenza vaccine since 2008
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of adverse events of the inactivated split influenza vaccine | two years |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titre of the inactivated split influenza vaccine | two years |
Countries
China
Outcome results
None listed