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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 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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ABSTRACT Background: Influenza burden in Brazil is considerable with 4.2-6.4 million cases in 2008 and influenza-like-illness responsible for 16.9% of hospitalizations. Cost-effectiveness of influenza vaccination may be assessed by different types of models, with limitations due to data availability, assumptions, and modelling approach. Objective: To understand the impact of model complexity, the cost-utility of quadrivalent versus trivalent influenza vaccines in Brazil was estimated using three distinct models: a 1-year decision tree population model with three age groups (FLOU); a more detailed 1-year population model with five age groups (FLORA); and a more complex lifetime multi-cohort Markov model with nine age groups (FLORENCE). Methods: Analysis 1 (impact of model structure) compared each model using the same data inputs (i.e., best available data for FLOU). Analysis 2 (impact of increasing granularity) compared each model populated with the best available data for that model. Results: Using the best data for each model, the discounted cost-utility ratio of quadrivalent versus trivalent influenza vaccine was R$20,428 with FLOU, R$22,768 with FLORA (versus R$20,428 in Analysis 1), and, R$19,257 with FLORENCE (versus R$22,490 in Analysis 1) using a lifetime horizon. Conceptual differences between FLORA and FLORENCE meant the same assumption regarding increased all-cause mortality in at-risk individuals had an opposite effect on the incremental cost-effectiveness ratio in Analysis 2 versus 1, and a proportionally higher number of vaccinated elderly in FLORENCE reduced this ratio in Analysis 2. Discussion: FLOU provided adequate cost-effectiveness estimates with data in broad age groups. FLORA increased insights (e.g., in healthy versus at-risk, paediatric, respiratory/non-respiratory complications). FLORENCE provided greater insights and precision (e.g., in elderly, costs and complications, lifetime cost-effectiveness). Conclusion: All three models predicted a cost per quality-adjusted life year gained for quadrivalent versus trivalent influenza vaccine in the range of R$19,257 (FLORENCE) to R$22,768 (FLORA) with the best available data in Brazil (Appendix A).