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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.
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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.
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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.
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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.
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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.
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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.
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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.