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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.
ABSTRACT
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 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.
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<p><b>OBJECTIVE</b>To analyze the occurrence feature of adverse events following immunization (AEFI) of Hib conjugate vaccine (HibCV) and to evaluate the safety of HibCV in postmarketing.</p><p><b>METHODS</b>2008-2013 HibCV AEFI data were collected through national AEFI information management system, which were downloaded in March 18, 2014.The demographic information and inoculation quantity of HibCV were from Immunization information management system in Jiangsu province. The incidence rate and 95% CI value of AEFI, common vaccine reaction and rare vaccine reaction following immunization of HibCV were calculated. The differences in the incidence rate of common vaccine reaction and rare vaccine reaction among sex, months of age, and number of injections were compared by means of (χ² tests.</p><p><b>RESULTS</b>A total of 6.16 million doses of vaccine were administered in Jiangsu province during 2008-2013, and 4 718 vaccinees reported having adverse event, for a rate of 76.60/100 000 (95% CI: 74.42/100 000-78.79/100 000). The incidence rate of common vaccine reaction and rare vaccine reaction was 71.10/100 000 (95% CI: 68.99/100 000-73.20/100 000) and 5.16/100 000 (95% CI: 4.60/100 000-5.73/100 000), respectively. The main symptoms of common vaccine reactions were fever, swelling, indurations and gastrointestinal reactions. The incidence rates of them were 40.54/100 000, 35.09/100 000, 12.94/100 000 and 0.36/100 000 in turn. The main symptoms of rare vaccine reactions were anaphylactic rashes and angioedema, the incidence rates of which were 4.77/100 000 and 0.15/100 000 respectively. 91.39% (4 002/4 379) of common vaccine reactions and 88.36% (281/318) of rare vaccine reactions happened within 1 d after vaccination. Anaphylactic shock (3 cases) and laryngeal edema (1 case) all happened within 1 d after vaccination. The incidence rate of common vaccine reactions among boys (79.72/100 000, 2 641/3 313 071) was higher than that of girls (61.07/100 000, 1 738/2 846 001) (χ² = 74.92, P < 0.001). The incidence rate of common vaccine reactions among children aged ≥ 12 month-old (86.82/100 000, 2 200/2 533 949) was higher than that among children aged 2-11 month-old (60.11/100 000, 2 179/3 625 123) (χ² = 149.79, P < 0.001). The incidence rate of common vaccine reactions in children vaccinated the first dose (78.93/100 000, 2 666/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (61.59/100 000, 1 713/2 781 458) (χ² = 64.59, P < 0.001). The incidence rate of rare vaccine reactions in children vaccinated the first dose (6.69/100 000, 226/3 377 614) was higher than that in children vaccinated the second or third or fourth dose (3.31/100 000, 92/2 781 458) (χ² = 33.82, P < 0.001).</p><p><b>CONCLUSION</b>The safety of HibCV among children was relative good. However, the surveillance should still focus on the anaphylactoid reactions of anaphylactic shock and laryngeal edema after HibCV immunization.</p>