Human Influenza Clinical Trial
Official title:
A Randomised, Controlled Phase IV Clinical Trial With an Inactivated Influenza Vaccine(Split Virion)
Influenza vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml) of Hualan Biological
Bacterin Co., Ltd (The subsidiary of Hualan Biological Engineering INC.) is applicable to
the influenza immunity of age 3 and older population. Phase III clinical study was conducted
in Jintan City, Jiangsu Province in May, 2006. Trial results showed that this vaccine had
good safety and immunogenicity. Hualan Bio Influenza Vaccine obtained its production
approval(China Drug Approval No.: S20083016) for marketing on April 3rd, 2008.
In order to monitor and evaluate the safety and protective effect against influenza
administered on age 3 and older population, therefore we conduct the phase IV clinical trial
of the licensed Influenza Vaccine (split virion), Inactivated (15ug HA/subtype/0.5ml).
Select three sites to conduct this study in Henan, china. In the principle of informed
consent and voluntary participation, adopt randomized and control design and include 6000
healthy subjects, among them, trial group 3000 persons, blank control group 3000 persons
respectively and randomized dividing into 4 age groups.
The evaluation of safety: For all the vaccinated subjects, monitor general reaction and
post-vaccination AEFI by mean of active soliciting and passive report. The evaluation of
safety data mainly includes summary of clinical reaction endpoint, local and systemic
adverse events of all subjects during the observation period and incidence rate of relevant
ADR/AE.
The evaluation of immunogenicity: Respectively and randomly sample 600 persons from
vaccination group and blank control group. Collect venous blood on the first day or 28 day
of vaccination. Adopt international universal HI testing method(SRID) to carry out serology
test.
The criteria for HI antibody test result:
- Take 1:10 serum as the lowest dilutability. For subjects whose HI antibody <1:10 before
immunization, calculate as 1:5 and their post-vaccination HI antibody titer≥1:40 will
be as the seroconversion. For subjects HI antibody ≥1:10 before the vaccination, take
post-vaccination HI antibody titer increases 4 times as seroconversion;
- Take HI antibody titer≥1:40 as threshold of positive protection;
- Take statistics of subject number whose serum HI antibody titer reach protective level
(HI antibody titer≥1:40). Calculate protection rate of vaccine and 95% CI;
- GMT titer and 95% CI. Evaluation of immune protective effect: Monitor Influenza Like
Illness(ILI) to all subjects in monitoring place and conduct epidemiological survey to
ILI. Collect nasopharyngeal swab and blood specimen during acute and recovery period
for the laboratory test.
ILI refers to fever (body temperature≥38℃) with cough or pharyngalgia. Test influenza virus
nucleic acid in nasopharyngeal swab. Isolate serum of blood specimen and carry out the test
of serum antibody.
Evaluation indicator:
- Statistics of ILI incidence rate in immune population
- Statistics of incidence rate in monitoring place
;
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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