Safety and immunogenicity of combined immunization with live rotavirus vaccine (oral) and measles, mumps and rubella vaccine / 中华微生物学和免疫学杂志

Objective:To evaluate the difference in safety and immunogenicity of live rotavirus vaccine (oral) and measles, mumps and rubella (MMR) vaccine immunized alone or in combination.Methods:This study recruited 1 752 children aged 8-9 months who had not been vaccinated with live rotavirus vaccine (oral) or MMR vaccine after birth. The subjects were divided into three groups: study group (652 subjects, immunized with live rotavirus vaccine and MMR vaccine), control group 1 (723 subjects, immunized with live rotavirus vaccine) and control group 2 (377 subjects, immunized with MMR vaccine). Local and systemic adverse reactions within 30 d after vaccination were recorded. Serum samples were collected before and 35-42 d after immunization for analyzing the changes in antibodies.Results:Immunization alone or in combination with live rotavirus vaccine (oral) and MMR vaccine achieved similar results in the positive rates and concentrations of antibodies against rotavirus, measles and rubella viruses ( P>0.05). Moreover, the positive rates and the concentrations of the three antibodies were increased after vaccination. Compared with the control group 2, the concentration of antibody against mumps virus in the study group was increased ( P<0.05), but no significant difference in the positive rate of antibody against mumps virus was found between the two groups ( P>0.05). The positive rate and the concentration of antibody against mumps virus were increased after combined immunization or immunization with MMR vaccine alone. The overall incidence of fever and diarrhea was 1.54% (27/1 752) and 0.63% (11/1 752). No other abnormal reactions, incidental reactions or adverse reactions of any clinical significance were observed. Conclusions:Live rotavirus vaccine (oral) and MMR vaccine immunized alone or in combination showed good immunogenicity and safety.

Analysis of four subtypes original research in biomedicine and enlightenment for reseach management / 中华医学科研管理杂志

Objective:To explore the stage connotation and characteristics of original research in the field of biomedicine.Methods:Through theoretical analysis and case studies, the original research in the field of biomedicine is subdivided into four subtypes, and the development laws and countermeasures are discussed in this paper.Results:The original research in biomedicine can be divided into four subtypes according to its dynamic process, which includes Budding (0-0.1), Bottleneck (0.1-1), Expansion (1-N) and Iteration (1- New 1). Each subtype has different technological advancement, maturity, scale, and influence.Conclusions:Analysing the original connotation and laws of the subtypes of 4 original research in biomedicine provides relevant suggestions on formulating funding, development strategies, as well as promoting original medical innovation.

Post-marketing immunogenicity and safety of domestic 23-valent pneumococcal polysaccharide vaccine: a multicenter study / 中华微生物学和免疫学杂志

Objective:To evaluate the post-marketing safety and immunogenicity of a 23-valent pneumococcal polysaccharide vaccine (PPV23).Methods:From September 2020 to June 2021, a clinical trial of single-dose PPV23 was conducted in people ≥3 years old in Centers for Disease Control and Prevention of Guizhou, Hunan and Fujian provinces. Blood samples were collects from the subjects before and 30 d after vaccination. ELISA was used to quantitatively detect IgG antibodies against capsular polysaccharides of 23 Streptococcus pneumoniae serotypes in serum samples. The adverse events (AEs) were monitored within 7 d after vaccination. Results:A total of 409 subjects were enrolled and included in safety analysis. Except for one with antibody level inversion, the other 408 participants were included in immunogenicity analysis. The levels of antibodies against the 23 Streptococcus pneumoniae serotypes were all increased after vaccination by an average of 4.24 folds. The two-fold growth rates of the antibodies ranged from 51.72% to 96.81% with a total two-fold growth rate of 78.59%. The overall rate of AEs was 27.14% (111/409). Local AEs were mainly pain, induration, redness and swollen. No serious adverse events related to vaccination occurred. Conclusions:This study preliminarily demonstrated the good immunogenicity and safety of PPV23 vaccine.

Antibody persistence 3 to 5 years after vaccination with measles, mumps and rubella combined attenuated live vaccine in children / 中华微生物学和免疫学杂志

Objective:To assess the antibody persistence 3-5 years following vaccination of measles and rubella combined live-attenuated vaccine (MR) at 8 months of age and measles, mumps and rubella combined attenuated live vaccine (MMR) at 18 months of age.Methods:In 2016, 18-month-old children who were vaccinated with one dose of MR vaccine at the age of 8 months were recruited in Hebei Province as group 1; 4-, 5- and 6-year-old children who were vaccinated with one dose of MR vaccine at the age of 8 months and one dose of MMR vaccine at 18 months of age were recruited in Shanxi, Inner Mongolia and Beijing as group 2, group 3 and group 4, respectively. Serum samples were collected to detect IgG antibodies against measles, mumps and rubella by ELISA. Geometric mean concentrations (GMCs) of measles, mumps, and rubella antibodies were compared among groups by analysis of variance or non-parametric test. Seropositive rates were compared among groups by Chi-square test or Fisher′s exact test. Results:A total of 650 children were included in this study. Seropositive rates of measles, mumps and rubella antibodies 30 d after vaccination of 150 18-month-old children with one dose of MMR vaccine were 100%, 91.33% and 100%, respectively, and the GMCs were 1 846.87 mIU/ml, 299.91 IU/ml and 111.33 IU/ml, respectively. Seropositive rates of measles, mumps and rubella antibodies 3-5 years after vaccination one dose of MR vaccine at 8 months of age and one dose of MMR vaccine at 18 months of age were above 94%, 79% and 71%, respectively, and the GMCs were above 830 mIU/ml, 240 IU/ml and 31 IU/ml. No significant difference in the seropositive rates of the three antibodies was observed among groups 2, 3 and 4 ( P>0.05). There was no significant difference in the GMCs of measles or mumps antibodies among the three groups ( P>0.05), but the differences in the GMCs of rubella antibodies were statistically significant ( P=0.034). Conclusions:Measles, mumps and rubella antibodies persisted for 3-5 years without significant decrease after vaccination one dose of MR vaccine at 8 months of age and one dose of MMR vaccine at 18 months of age.

Analysis of post-marketing safety monitoring of split influenza virus vaccine based on large samples / 公共卫生与预防医学

Objective To evaluate the safety of a Chinese thimerosal-free trivalent split influenza virus vaccine after being marketed in a large population. Methods Through the information management system of adverse event following immunization (AEFI), the adverse events in healthy people aged 6 months and above who were vaccinated with split influenza virus vaccine in Hubei Province from October to December 2015 were collected. The data was analyzed by descriptive methodology. Results From October 1, 2015 to June 30, 2016, among the 227 920 people in Hubei Province who were vaccinated with split influenza virus vaccine, the common adverse reactions were mainly fever, redness, irritability, pain and itching. Four cases of AEFI were passively observed and reported in the system, with a reporting rate of 1.76/100 000, among which 3 cases were anaphylactic rash and 1 case was optic neuritis. Conclusion The Chinese thimerosal-free trivalent split influenza virus vaccine used in Hubei Province had a good safety record and is suitable for the general vaccination of people without vaccination contraindications.

Surveillance results of adverse events following immunization of enterovirus 71 inactvated vaccine / 预防医学

Objective@#To evaluate the safety of enterovirus 71（EV71）inactivated vaccines produced by Wuhan Institute of Bio Products through learning the incidence of adverse events following immunization（AEFI）in children aged 6 months to 3 years old after vaccination.@*Methods@#According to the national requirement for vaccine safety monitoring program，data of AEFI cases after inoculated EV71 vaccines from September 2017 to October 2018 in Zhejiang Province was collected by combining active and passive monitoring. Demographic characteristics，space distribution，dose and incidence of AEFI were analyzed.@*Results@#A total of 107 503 children were included in this study，of which 27 173 were actively monitored and 80 330 were passively monitored. The monitoring results showed that 288 cases of AEFI occurred after inoculated EV71 vaccines，the reported incidence rate was 267.90/100 000. Of 288 cases，266 cases had common reactions（247.43/100 000），14 cases had abnormal reactions（13.02/100 000）and 8 cases had complications（7.44/100 000）；145 cases were passively monitored（180.51/100 000）and 143 cases were actively monitored（526.26/100 000）；150 cases were males and 138 cases were females，with the males to females ratio of 1.09∶1. The AEFI of EV71 vaccines were reported in all the cities of Zhejiang Province，with Jinhua，Taizhou and Hangzhou ranking the top three and accounting for 50.69% of all the reported cases. About 202 cases of AEFI（70.14%）occurred after the first dose of EV71 vaccines，and 163 cases（56.60%）occurred on the day of inoculation.Most of common reactions were fever，swelling and sclerosis. The harm of the reported abnormal reactions was mild，with 8 cases of anaphylactic rash and no other serious abnormal reactions were found. @*Conclusion@#The reported incidence rate of AEFI of the domestic EV71 vaccine in children aged from 6 months to 3 years is 267.90/100 000，without serious abnormal reactions，suggesting that the EV71 vaccine is safe.

Immunogenicity and safety of co-immunization with 23-valent pneumococcal polysaccharide vaccine and influenza virus split vaccine for children aged 3-7 years / 中华微生物学和免疫学杂志

Objective@#To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine (PPV23) and trivalent influenza vaccine (TIV) in preschoolers.@*Methods@#A total of 1 035 children aged 3-7 years were enrolled in this study and randomly divided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis.@*Results@#A total of 1 035 serological specimens were collected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No significant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the concomitant vaccination group showed higher serological conversion rate of H3 type (88.75% vs 84.20%, P=0.01), but lower serological conversion rate of B type (92.84% vs 98.56%, P<0.001). There was no significant difference in the primary adverse reactions between the three groups (P=0.197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3.61%, which was higher than that of the other two groups (both P<0.001). All adverse reactions were mild or moderate, and cured after treatment.@*Conclusions@#Concomitant immunization with PPV23 and TIV is safe and have good immunogenicity, thus a viable immune strategy for susceptible children.

Immunogenicity and safety of co-immunization with 23-valent pneumococcal polysaccharide vaccine and influenza virus split vaccine for children aged 3-7 years / 中华微生物学和免疫学杂志

Objective To evaluate the immunogenicity and safety of concomitant administration of 23-valent pneumococcal polysaccharide vaccine ( PPV23) and trivalent influenza vaccine ( TIV) in pre-schoolers. Methods A total of 1035 children aged 3-7 years were enrolled in this study and randomly di-vided into three groups, inoculated PPV23, TIV and both, respectively. A one-year follow-up study was conducted for immunogenicity and safety analysis. Results A total of 1035 serological specimens were col-lected, including 327 in PPV23 group, 348 in TIV group and 360 in concomitant vaccination group. No sig-nificant differences in geometric mean concentrations (GMC) of seven pneumococcal serotypes were observed between the PPV23 group and the concomitant vaccination group. Compared with the TIV group, the con-comitant vaccination group showed higher serological conversion rate of H3 type (88. 75％ vs 84. 20％ , P=0. 01), but lower serological conversion rate of B type (92. 84％ vs 98. 56％ , P<0. 001). There was no significant difference in the primary adverse reactions between the three groups (P = 0. 197). The rate of secondary adverse reactions occurred in the concomitant vaccination group was 3. 61％ , which was higher than that of the other two groups (both P<0. 001). All adverse reactions were mild or moderate, and cured after treatment. Conclusions Concomitant immunization with PPV23 and TIV is safe and have good immu-nogenicity, thus a viable immune strategy for susceptible children.

Application of Current Perception Threshold in Lumbar Radiculopathy / 中国康复理论与实践

@#Objective To investigate the change of current perception threshold (CPT) in patients with lumbar radiculopathy. Methods From September, 2014 to October, 2015, 86 patients with lumbar radiculopathy from lumbar disc herniation were measured with CPT in different frequencies (5, 250 and 2000 Hz) on proximal and distal points of affected dermatome of both legs. Results The CPT grades of both proximal and distal points were higher in the affected legs than in the contralateral legs (t=1.659, P<0.001). The abnormal CPT grades counted for 46.36% for both points, 35.45% for only distal points and 35.45% for only proximal points. CPT was abnormal in all the patients, and 93.6% of them appeared at 250 Hz, 57.4% at 2000 Hz, and 29.8% at 5 Hz.Conclusion CPT is sensitive in lumbar radiculopathy, especially in multiple frequencies and test points.

Safety and immunogenicity of influenza vaccine (split virion) in humans / 中华微生物学和免疫学杂志

Objective To evaluate the immunogenicity and safety of a split-virion influenza vac-cine after its manufacturing process was improved. Methods The immunological non-inferiority of trial to control vaccines was evaluated in 240 subjects aged 3-<18 years. Another 360 subjects aged 18-<60 years were randomly divided into three groups that were respectively given three consecutive lots of trail vaccine to assess the consistency of immunogenicity. Results There were 4. 17% of the subjects aged 3-<18 years showed adverse reactions following immunization with trail vaccine and it was not significantly different from that of the control group (P>0. 05). No significant difference in seroconversion rate, geometric mean titer (GMT) of haemagglutination inhibition antibodies(HIAb) or protection rate was found between trial and control groups (P>0. 05). No significant difference in seroconversion rate or HIAb GMT was found among the three lots (P>0. 05). Conclusion The trial influenza vaccine has good safety, immunogenicity and lot-to-lot consistency after the manufacturing process was improved.

Immunogenicity and safety of a booster dose of live attenuated measles-mumps-rubella vaccine for 4-year-old children / 中华微生物学和免疫学杂志

Objective To evaluate the immunogenicity and safety of a booster dose of live attenua-ted measles-mumps-rubella (MMR) vaccine for 4-year-old children and to provide references for reasonable arrangement of MMR immunization schedule. Methods Children aged 4 years (54-60 months) old were recruited and divided into three groups as follows: Group 8 months MR [receiving live attenuated measles and rubella(MR) vaccination at 8 months and MMR vaccination at 18 months],Group 8 months MMR(re-ceiving MMR vaccination at both 8 and 18 months) and Group 12 months MMR(receiving MMR vaccination at both 12 and 22 months). Active follow-up was conducted for safety evaluation after immunization of all subjects with the booster dose of MMR vaccine. Blood samples were collected before and 35 days after vacci-nation and analyzed by ELISA to detect serum antibodies to measles,mumps and rubella. Results A total of 514 subjects were enrolled in this study of safety evaluation and 469 of them received serologic detection of antibodies twice. The rate of adverse reactions following vaccination was 17.12% (general reactions accoun-ted for 94.21%) and no severe adverse reactions were reported. No significant difference in the rates of ad-verse reactions was found among the three groups (χ2=4.82, P=0.090). Subjects who were seropositive for measles, mumps and rubella increased after immunization with MMR vaccine, accounting for 100%, 99.79% and 99.79%,respectively. Geometric mean concentrations (GMC) against measles, mumps and rubella in all subjects were 1.35,3.05 and 2.13 times higher than what they were before the immunization. Levels of antibodies to measles,mumps and rubella were all increased significantly in the three groups after immunization with the booster dose of MMR vaccine (Fisher Exact Test, P=0.000). Conclusion The booster dose of MMR vaccine increases the levels of serum antibodies in children aged 4 years old with high safety. It suggests that two doses of MMR vaccine should be encouraged in the immunization program in China.

Neutrophil/lymphocyte ratio in prediction of incidence of ischemic stroke in elderly persons with chronic kidney disease / 中国医师杂志

Objective To investigate the relationship of the neutrophil to lymphocyte ratio (NLR)with stroke in elderly persons with CDK.Methods Totally 220 subjects with stage 3-5 CKD were followed.Fatal and nonfatal cerebrovascular event (CVE) were recorded during this period.NLR at baseline was determined from complete blood count differential.We investigated if NLR could predict stroke.Resuits Median NLR was 2.13.NLR was equally associated with estimated glomerular flitrationrate (eGFR).Totally 116 strokes occurred during follow-up period.NLR could predict stroke independently.Increased NLR over 2.13 was related to a significantly decreased survival time (log-rank Chi-square =4.963,P =0.026).Multivariate Cox regression analysis showed that the risk factor of ischemic stroke in CKD patients was high NLR,hazard ratio (HR) 1.11 [95％ confidence interval (CI) 1.007 to 1.223,P =0.035].Conclusions NLR could independently predict stroke in elderly patients with moderate to severe CKD.

Analysis of the effect of traditional Chinese medicine fumigation and washing for hemorrhoids / 中国基层医药

Objective To observe the application effect of traditional Chinese medicine fumigation in the treatment of hemorrhoids.Methods 80 patients with hemorrhoids were chosen as the research subjects,they were randomly divided into two groups.40 cases in the control group received conventional western medicine treatment,40 cases in the observation group were treated by traditional Chinese medicine fumigation.The symptom scores before and after treatment,the symptoms disappear time and clinical effect were compared between the two groups.Results The total effective rate of the observation group was 90％,which was significantly higher than 75％ of the control group (x2 =4.12,P ＜ 0.05).After treatment,the anal pain,anal edema,anal pruritus,bloody symptom scores of the two groups were lower than before treatment,the symptom scores after treatment between the two groups had statistically significant differences (t =12.11,13.02,14.19,12.09,all P ＜ 0.05).The disappearance time of anal pain,anal edema,anal urticant,bloody of the observation group were (4.1 ± 0.2) d,(3.4 ± 0.1) d,(4.0 ± 0.2) d,(5.0 ± 1.1) d,respectively,which were shorter than those of the control group [(6.9 ± 0.5) d,(6.0 ± 1.1) d,(6.8 ± 1.1)d,(8.0 ± 0.2)d],the differences between the two groups were statistically significant (t =13.10,13.09,14.18,11.29,all P ＜ 0.05).Conclusion Chinese medicine fumigation in the treatment of patients with hemorrhoids,anal pain,anal edema,can significantly improve the patients’ symptoms such as anal urticant,bloody,the clinical effect is superior to conventional western medicine treatment.

Post-marketing evaluation of the effectiveness and safety of a varicella attenuated live vaccine in ;China / 中华微生物学和免疫学杂志

Objective To evaluate the effectiveness and safety of varicella attenuated live vaccine ( VarV) produced by A Co. Ltd. Methods We selected 3 provinces in China and enrolled 15 002 children aged 3-<11 in this random, multicenter study. Participants were randomly divided into two groups: the ex-perimental group and the control group. Every varicella case was collected and recorded to calculate the vac-cine efficacy. Vaccine safety was assessed by means of spontaneous report and regular follow-up visits. Re-sults During the observation period, the incidence of varicella was 0. 147% in the experimental group and 1. 155% in the control group (P<0. 001). The vaccine efficacy was 87. 27%. The adverse reaction rate af-ter vaccination was lower than the rates reported in other literatures. Conclusion The VarV produced by A Co. , Ltd. in China was effective and safe in preventing varicella.

The clinical observation of methotrexate under hysteroscopy by tubal cavity injection with Huayu shapei pre-scription in the treatment of tubal pregnancy / 中国基层医药

Objective To explore the clinical effects of injecting methotrexate with hysteroscopic tubal can-nulation combined with Huayu shapei prescription in the treatment of salpingocyesis.Methods 82 unruptured salpin-gocyesis patients were randomly divided into the two groups.41 patients in the observation group were treated by hyst-eroscopic tubal cannulation injection of methotrexate combined with Huayu shapei prescription,41 patients in the con-trol group were treated by methotrexate intramuscular injection with oral mifepristone.The clinical efficacy of the two groups were observed,the level of serumβHCG required for tubal pregnancy,the mass absorption and after treatment of tubal patency.Results Compared with the control group,the difference was significant of the decline of serum βHCG in the treatment group (t=2.67,P<0.05).Compared with the control group,the treatment effectiveness and the absorption of the mass in fallopian tube in the treatment group,the difference was significant (t =3.57,P<0.05 ).Tubal patency detected treated group was superior compared with the control group,the difference was signifi-cant(χ2 =100.23,P<0.05).Conclusion Compared with traditional treatments,injecting methotrexate with hyste-roscopic tubal cannulation combined with Huayu shapei prescription in the treatment of salpingocyesis can effectively reduce the HCG levels,promote the absorption and softening of the ectopic pregnancy mass,to achieve the purpose of killing embryos eliminate micro,it will help to improve patients with clinical symptoms and signs,to maximize the recovery of the patient's reproductive function and physical health.

Situation analysis on kidney damage of the 1088 elderly health examination people / 中华老年医学杂志

Objective To analyse the kidney damage situation of the elderly health examination people,and identify its characteristic.Methods A cross-sectional study was held which enrolled 1088 elderly health examination people.Urine routine,random urine albumin/creatinine ratio (ACR),serum creatinine,urea nitrogen were detected by biochemical analyzer,and estimated glomerular filtration rate (GFR) with CKD-EPI formula.Kidney structure change was examined by Color doppler ultrasound detector.Results The prevalence of hypertension,hyperlipemia,diabetes mellitus was 61.5％,62.1％,11.6％,respectively.The abnormal detection rate of urine routine was 19.0％,including 2.6％ proteinuria,14.1％ hematuresis and 5.4％ leucocyturia.The abnormal detection rate in the people with was higher than those without (P＜0.01).However,the albuminuria detection rate with random urine ACR was 25.1％,obviously higher than that of urine routine (P＜0.01).The ultrasound results showed that 6.8％ of the total were examined with elderly characteristic kidney change,the proportion of renal cyst was the highest,accounted for 21.8％.70.7％ of all people were in the level of eGFR more than 60 ml· min-1 · 1.73 m-2.The level of eGFR＜60 ml· min-1 · 1.73m-2 in the people with was higher than those without (P＜0.01).eGFR was declined with age.When age increased every 10 years,eGFR was decreased 7 ml · min-1 · 1.73 m-2.Conclusions No matter in structure or function,the elderly people's kidney damage has its characteristic.We should make it clear to correctly diagnose and cure elderly kidney disease.

Relativity between clinical learning organization culture and core competency of registered nurses / 中华医院管理杂志

Objective To explore the relativity between clinical learning organization culture and core competency among registered nurses,to offer theoretic basis and practical advices for improving core competency among registered nurses.Methods 680 registered nurses in three tertiary hospitals in Ji'nan city were investigated with the general information questionnaire,Competency Inventory for Registered Nurses and the Dimensions of The Learning Organization Questionnaire.Results The total score and all the four subscales of learning organization were positively correlated with the core competency among registered nurses(P＜0.01),the dimension of overall situation senses and strategic leadership were the main influencing factors.Conclusions The cultivation of nurses' overall situation senses should be strengthened,providing strategic leadership for learning,strengthening cooperation and innovation,and promoting inquiry and communication.These will help increase core competency among registered nurses and improve their general competence.

Clinical analysis of drug-induced liver injury in the elderly / 中华老年医学杂志

Objective To investigate the causes, clinical features, classifications and liver function change of drug-induced liver damage (DILD) in the elderly. Methods One hundred and sixty seven inpatients with acute drug-induced liver injury in our hospital in the past ten years (January 2000 to December 2009) were retrospectively investigated,and the diagnosis and classification methods of acute DILD were based on international consensus meeting (international criteria). Results Among 167 DILI cases, there were 53 cases (31.7%) in the older group and 114 cases (68.3%) in middle-youth age group. Fatigue and jaundice were the more common symptoms, accounting for 50.3% and 46.7%, respectively. In 167 cases, no obvious symptoms and signs were shown in 25 cases. There were no significance differences in clinical manifestation between two groups. Many drugs could induce liver injury. The most common drugs inducing DILD were Chinese traditional and herbal drugs, accounting for 47.9%. Drugs used in heart diseases and inducing liver injury were more common in the older group. In this study, 40 (75.5%), 5 (9.4%) and 8 (15.1%) cases were designated as hepatocellular, cholestetic and mixed DILD in the older group, and 91 (78.9%), 8 (7.4%) and 15 (13.7%) in middle-youth age group, respectively. There were no significance differences between two groups in classifications. Conclusions Many drugs could cause liver injury. The symptoms of acute DILD are nonspecific. Drugs used in heart diseases and inducing liver injury are more common in older patients.

Preparation of influenza A (H1N1) split-virus vaccine and preliminary clinical trail / 中华微生物学和免疫学杂志

Objective To prepare an influenza A(H1N1) split-virus vaccine and observe its safe-ty and effectiveness. Methods According to the process for preparing seasonal flu split-virus vaccine two batches of vaccine were prepared with the flu A (H1N1) vaccine virus strain recommended by WHO. The pilot products were tested against the requirements of flu split-virus vaccine. Results The quality of the pi-lot vaccine has been tested by National Control Laboratory and conformed to the requirements. Nine hundred and sixty volunteers received one dose of vaccine containing either 15 μg or 30 μg of hemagglutinin. The re-suits indicated the both seroconversion rate and protection rate were higher the 70%. The GMT of HIAb of the volunteers who received 1 dose of 15 μg increased significantly by 15, 39, 37 and 25 times compared to those before vaccination in the age groups of 3-11, 12-17, 18-59 and ≥60, respectively. And 26, 72, 68 and 36 times rise were found in the postvaccinated volunteers of 30 μg group. The total adverse reaction rates of 15 μg and 30 μg dose group were 29.38% and 43.75%, respectively. The grade 2 adverse reaction rates of 15 μg and 30 μg dose group were 6.25% and 15.42%, and the grade 3 adverse reaction rates of 15 μg and 30 μg dose group were 0.83% and 1.46%, respectively. No serious adverse reactions were found. Conclusion The influenza A (H1N1) split-virus vaccine prepared according to the requirements of season-al flu vaccine is safe and effective.