RESUMO
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.
RESUMO
<p><b>OBJECTIVE</b>To study the safety and immunogenicity of the measles-mumps-rubella combined vaccine (MMR) produced by Beijing Biological Product Institute.</p><p><b>METHODS</b>Children aged 10-12 years, 2-2.5 years and 8-12 months were selected to be vaccinated with Beijing MMR vaccine (test vaccine). Other groups of children with similar nature were vaccinated with measles vaccine, mumps vaccine and rubella vaccine while using imported MMR vaccine (control vaccine) as controls.</p><p><b>RESULTS</b>The safety of the Beijing MMR vaccine was confirmed after vaccinating 32 children above 2 years old. Among 104 children of 8-12 months were vaccinated with Beijing MMR vaccine, only 6.7% of the children had transient fever and 1.9% had signs of rashes but with no other signs observed. The positive seroconversion rates of measles, rubella and mumps anti-HI were 100%, 100% and 85.7% respectively. GMT also showed high lever.</p><p><b>CONCLUSION</b>The MMR vaccine (Beijing) had good safety and immunogenicity which might be used to be the bases enhance immunization of measles.</p>