Influenza
Conditions
Keywords
Influenza Vaccine, Vaccination,
Brief summary
The clinical trial was conducted in Jintan City of Jiangsu Province, China in May, 2006. The purpose of the clinical trial was to evaluate the safety and immunogenicity against Hualan's Influenza Vaccine (Split Virion), Inactivated (0.5ml) administered on age 6 months and old population.
Detailed description
The clinical trial was designed randomized and blind. Participants included up to 900 persons. The clinical trial had two stages: the first stage selected 60 subjects to be administered test vaccine for preliminary safety study; 840 subjects were selected at the second stage for the observation of the safety and immunogenicity against the test vaccine administered on large population on the basis of the first stage. There were 560 subjects and 280 subjects in the test group and control group respectively. Venous blood from subjects was collected before immunization and 4 weeks after the whole immunization for the analysis of the immunogenicity. The information about adverse reactions/time was reported to the SFDA every month during the trial under the status of blinding. Unblinding was conducted after the subject follow-up and observation.
Interventions
BIOLOGICALInfluenza split vaccine of 15 μg HA
60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
BIOLOGICALInfluenza split vaccine
280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
Sponsors
Hualan Biological Engineering, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Inclusion criteria for the primary vaccination on subjects over 3 years old and subjects 6 months～3 years old * Healthy male and female 6 months or over, subject (or their guardians) are able to understand and sign informed consent * Healthy person by inquiring illness history, physical examination and clinical judgment and who complies with vaccination of this product * Be able to comply with the requirement of clinical trial protocol * Have no history of influenza vaccination within the past 6 months and vaccination with other product within the latest 1 week; * Axillary temperature\<37.1℃. 2. Inclusion criteria for the boost vaccination on subjects age 6 months～3 years * Have no history of vaccination with other preventive product within the latest 1 week; * Axillary temperature\<37.1℃.
Exclusion criteria
1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events as a measure of safety study | 28 days after the vaccination | Include ADR, adverse event and severe adverse event. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Observation of immunogenicity | 28 days after the immunization | The rate of seroconversion, the rate of seroprotection, the GMT, and the antibody increasing folds of the subjects after administration with the vaccine. |
Countries
China
Outcome results
None listed