| Objective 1) to observe the safety of domestic influenza vaccine in the population from different ages and different areas and to detect the un-recorded symptom of adverse events; 2) to investigate the safety and immunogenicity of influenza vaccine in the elders above 60 years old.Methods The safety observation was open blind design, and the trial was performed in 15 local Center for Disease Control and Prevention during 2007 to 2008. A total of 2800 subjects aged from 6 m to 90 y were located in groups of young children, children, adults and elders. The open blind designed safety and immunogenicity study in elders was performed in Lanshan County in Hunan province.140 elders aged 61 y to 75 y received on dose of Anflu. The influenza vaccine of adult form is 0.5 ml/dose, containing 15μg haemagglutinin antigen of each H1N1, H3N2 and B strains; the vaccine of junior form is 0.25 ml/dose, containing 7.5μg haemagglutinin antigen of each H1N1, H3N2 and B strains. The vaccination schedule for adult form vaccine is one injection. The schedule for junior form vaccine is two injections at 0,28 day. After injection subjects were observed for 30 min for any immediate reaction, and the follow-up at 24,48 and 72 h were performed. The multi-center safety observation was terminated at day 7 when no adverse event was reported to the investigator. In the safety and immunogenicity study in elders, the safety observation was lasted to day 21, and blood samples were collected just before vaccine infection and the day 21. The immune response was measured by HI test. We checked the case report form, imported data in the data base, performed the statistic analysis after the data base was locked. The clinical trial monitor also examined data analysis report to verify the truthfulness and science of the clinical study.Results The safety observation included 2934 subjects aged from 6 m to 90 y. 599 subjects were in young child,613 subjects were in children group,485 subjects were in adolescent group,553 subjects were in adults,684 subjects were in elders group. The gender ratio was 0.97:1 (male:female). Most subjects were Han nationality with some minority of Hui nationality, Men nationality, Man nationality, etc.In multi-center safety observation,197 cases adverse event were recorded, and the incidence was 6.7%. The incidence of junior form was 10.7%, the incidence of adult form was 5.7%. Most of the adverse events were mild with incidence of 4.6%; some adverse events were medium with incidence of 1.9%; the severe adverse events were un-common with the incidence of 0.3%. If analyze by symptoms, the local reaction was 2.0%and most of which were sore at injection site (1.7%), in addition to itch, redness and swell. The systemic reaction was 5.2%, most of which was fever (4.0%) and some were nausea, headache, vomit, poor appetite. Besides, there are 66 subjects having medical conditions (hypertension, diabetes mellitus, chronic pulmonary and cardiovascular disorders) and receiving long-term medicine therapy. The incidence of adverse events in those subjects having medical conditions was 4.5%(3/66). No correlation was found between adverse events and medical conditions. Generally speaking, inactivated influenza split vaccine Anflu have good safety profile without new and rare adverse events.130 paired serum samples were proceeded to immune response analysis. Before injection the HI antibody sero-protection rate were 14.6%-42.3%, GMT 9.5-26.5, and both of which were below the protection level. At day 21 after injection the HI antibody sero-conversion rate was 72.3%-95.4%, GMT increase fold was 8.0-41.1, sero-protection rate were 90.0%-100.0%. The above three serum index all reached and surpassed the EMEA and FDA standard for seasonal influenza vaccine.Conclusion This study also showed that elders need influenza vaccination because their antibody level was low. Anflu have good safety and immunogenicity profile. The raised antibody level by Anflu can provide the prevention for individuals and may also provide herd immunity. |
PDF Full Text Request