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To fully understand the safety of DTaP-IPV/Hib vaccination, we evaluated the differences between DTaP-IPV/Hib co-administration and separate administration of the DTaP, IPV and Hib vaccines (DTaP+IPV+Hib) based on adverse events following immunization (AEFI). All AEFI reported in Hebei Province, China, between 2020 and 2022 were included in this study. The risk difference (RD%), relative risk (RR), and Chi-square value were used to compare the differences in reported rates of AEFI between the DTaP-IPV/Hib and DTaP+IPV+Hib groups. From 2020 to 2022, 130 AEFI cases were reported in Hebei Province after DTaP-IPV/Hib vaccination, corresponding to an AEFI reported rate of 66.9/million doses, which was significantly lower than that for DTaP+IPV+Hib (9836 AEFI with a reported rate of 637.8/million doses). The overall reported rate of non-severe AEFI for DTaP+IPV+Hib vaccines was 9.5 times that of DTaP-IPV/Hib vaccination [95% confidence interval (CI): 8.0, 11.3]. Meanwhile, the reported rate of AEFI among infants aged 0-1 y was 9.8 times higher for DTaP+IPV+Hib than for DTaP-IPV/Hib (95% CI: 8.2, 11.7). DTaP+IPV+Hib vaccination also resulted in higher risks of high fever, localized redness and swelling, localized induration, and allergic rash compared with DTaP-IPV/Hib vaccination. The risk of AEFI, which were mostly mild reaction, was higher after vaccination with DTaP+IPV+Hib than after DTaP-IPV/Hib vaccination.
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Vacuna contra Difteria, Tétanos y Tos Ferina , Vacunas contra Haemophilus , Vacuna Antipolio de Virus Inactivados , Vacunas Combinadas , Humanos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Haemophilus/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Lactante , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/administración & dosificación , China/epidemiología , Femenino , Masculino , Vacunación/efectos adversos , Infecciones por Haemophilus/prevención & control , Esquemas de Inmunización , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/administración & dosificaciónRESUMEN
What is already known on this topic?: In China, there is limited data available on the use and coverage of the non-program, combined diphtheria, tetanus toxoid, acellular pertussis adsorbed, inactivated poliovirus and haemophilus influenzae type b (DTaP-IPV/Hib) pentavalent vaccine, and its role as a substitute for the separately administered standalone program vaccines. What is added by this report?: We evaluated the use and coverage of the pentavalent vaccine in nine provincial-level administrative divisions (PLADs) spanning eastern, central, and western China from 2019 to 2021. Initial use and coverage were low, but demonstrated annual growth albeit with regional and urban-rural discrepancies. The pentavalent vaccine was increasingly substituted for standalone vaccines over the course of this period. What are the implications for public health practice?: Parents in China are increasingly opting to replace the standard program vaccines with voluntarily purchased combination vaccines, particularly the pentavalent vaccine. The development of combination vaccines should thus be promoted in China, as it could enhance utilization and coverage rates, and decrease the economic burden.
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Background: The DTaP-Hib and DTaP-IPV/Hib combination vaccine can be used as a substitute for the diphtheria, tetanus, and acellular pertussis combined vaccine (DTaP). We aimed to evaluate the safety of multi-component vaccines containing DTaP by analyzing the reporting rates and characteristics of adverse events following immunization (AEFIs) in Linping District during the years 2019 to 2022. Methods: We obtained data of AEFI and vaccination from the National AEFI Surveillance System of China and Zhejiang Municipal Immunization Information Management System, respectively, during 2019-2022 for a descriptive, epidemiological analysis. Results: The total number of AEFI reported following vaccinations with DTaP-containing combination vaccines was 802 in Linping District from 2019 to 2022. The overall reporting rates of AEFIs following DTaP, DTaP-Hib, and DTaP-IPV/Hib vaccinations were 445.72 (537 cases), 536.29 (45 cases), and 306.13 (220 cases) per 100,000 doses in Linping District from 2019 to 2022, respectively. Only one case of a serious AEFI following DTaP vaccination, with a reporting rate of 0.83 per 100,000 doses. The composition ratio of vaccine product-related reactions for DTaP, DTaP-Hib, and DTaP-IPV/Hib were 99.81, 97.78, and 100.00%, respectively. The composition ratio of coincidental events for DTaP and DTaP-Hib were 0.19 and 2.22%, respectively. The reporting rates of total AEFIs for DTaP-IPV/Hib were lower than for DTaP. The reporting rate of local induration for DTaP-Hib was lower than for DTaP, and the reporting rates of local redness & swelling and local induration for DTaP-IPV/Hib were both lower than for DTaP. DTaP-IPV/Hib had a higher proportion of AEFIs in first quarter compared to DTaP. The reporting rate after the second dose of DTaP-Hib was higher than that of DTaP, and the reporting rates of AEFIs after the first dose and third dose of DTaP-IPV/Hib were lower than DTaP. Conclusion: The reported AEFIs to multi-component vaccines containing DTaP components during 2019-2022 in Linping District were mainly mild vaccine reactions. DTaP-containing combination vaccines demonstrated a good safety profile.
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Vacunas contra Difteria, Tétanos y Tos Ferina Acelular , China/epidemiología , Vacunas contra Difteria, Tétanos y Tos Ferina Acelular/efectos adversos , Inmunización , Vacunación/efectos adversos , Vacunas Combinadas/efectos adversos , HumanosRESUMEN
Background: Diphtheria-tetanus-acellular pertussis, polio, and Haemophilus influenza type B (DTaP-IPV/Hib) combination vaccine was introduced as a part of the Korea National Immunization Program (NIP) on June 19, 2017. Combination vaccines can improve vaccination rates by simplifying the vaccination schedule. Objective: To explain how the introduction of DTaP-IPV/Hib in the NIP has changed vaccination practices for infants. Methods: Using a nationwide vaccine registry, the proportion of infants who completed the full recommended doses of the primary series of DTaP, IPV, and Hib (D-I-H) within 12 months of age was estimated among those born between 2013 and 2019. Among those, the proportions of those who received the same DTaP components for all 3 doses during the primary series were calculated for the 2013-2016 and the 2017-2019 birth cohorts. Those who received the same component of DTaP throughout the entire primary vaccination schedule were categorized into 3 groups by DTaP components to compare the average frequency of medical visits for vaccination. Results: A total of 2,703,822 infants were born between 2013 and 2019, of which 96.7% completed full doses of the primary D-I-H series within 12 months of age. For the 2013-2016 birth cohorts, most received DTaP-IPV-only (75.4%), while most of the 2017-2019 birth cohorts received DTaP-IPV/Hib-only (81.0%) to complete the 3 doses for primary D-I-H series. The average frequency of medical visits for vaccination showed a significant difference across the 3 groups classified by DTaP components in every birth cohort (p < 0.001). Conclusions: After the introduction of DTaP-IPV/Hib, most infants completed the primary D-I-H series with the combination vaccine and there was a significant reduction in the average number of medical visits for vaccination. Our findings provide important insights for countries considering the introduction of combination vaccines into their NIP.
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@#Objective To compare the differences of safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine,DTaPIPV-Hib pentavaccine plus HepB single vaccine or DTaP-IPV-HepB pentavaccine plus Hib single vaccine,so as to provide a reference for the marketing and use of hexavaccine in China.Methods Randomized controlled trials(RCTs)of DTaP-IPVHib-HepB hexavaccine,DTaP triple vaccine,Hib,IPV and HepB vaccines published at home and abroad were searched.The safety and immunogenicity of the hexavaccine were evaluated by Meta-analysis using Revman 5.4.1 software.Results A total of 7 articles,8 RCTs and 3 429 subjects were included. Meta-analysis of safety showed that there was no significant difference in the incidence of injection site and systemic adverse reactions after vaccination with hexavaccine and pentavaccine plus single vaccine(P > 0. 05)except for induration at the inoculation site and crying. Meta-analysis of immunogenicity showed no significant difference in antibody indexes after vaccination with hexavaccine and pentavaccine plus single vaccine(P > 0. 05).Conclusion The safety and immunogenicity of DTaP-IPV-Hib-HepB hexavaccine in basic immunity was comparable to that of the control vaccine,and might be applied to infants and young children to prevent related diseases. However,due to the limitations of the quantity and quality of included studies,the above conclusions still depend on the further development of larger sample,multicenter and high-quality
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Background: To assess safety and tolerability of a diphtheria and tetanus toxoid, acellular pertussis, inactivated poliovirus and Haemophilus influenza type B conjugate adsorbed vaccine (DTaP-IPV + Hib), manufactured by Serum Institute of India Pvt. Ltd. (SIIPL)'s, the current first-in-human Phase 1 study was conducted in healthy adults. Methods: Vaccine was administered as a single 0.5 mL dose intramuscularly into deltoid muscle of 24 healthy adults aged 18-45 years, who were then followed prospectively for one month for safety outcomes. Results: All 24 participants completed the study in compliance with protocol. Four solicited adverse events were reported in three participants during the study; all adverse events were mild and recovered completely. No deaths, unsolicited adverse events, or serious adverse events were reported. Conclusion: SIIPL DTaP-IPV + Hib vaccine was well tolerated and safe in study subjects. Further clinical development will be conducted to assess safety and immunogenicity in young children, the target population.Clinical Trial Registration: CTRI/2017/07/009034.
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Combination vaccines can reduce the vaccination visit, simplify the vaccination schedule and efficiently improve management. This study was primarily designed to evaluate the economic impact of integrating the diphtheria-tetanus-acellular pertussis inactivated poliomyelitis and Haemophilus influenzae type B (DTaP-IPV-Hib) combination vaccine into the China National Immunization Program. A cost-minimization analysis (CMA) compared the costs associated with direct medical, direct nonmedical, and indirect social costs in four schemes was conducted. A budgetary impact analysis assessed the alternative schemes' financial impact on the healthcare budget. Direct medical costs were extracted using a costing questionnaire and an observational time and motion chart. Direct nonmedical (cost for transportation) and indirect costs (loss of productivity) were derived from parents' questionnaires. Replacement of the current vaccination scheme with DTaP-IPV-Hib combination vaccine, resulted in net increases in direct medical costs of 77.64% for alternative scheme 1, 146.54% for alternative scheme 2, and 294.67% for alternative scheme 3, respectively. However, the direct nonmedical and indirect costs and the cost of the alternative schemes were 18.18%, 36.36%, and 63.64% lower than the current scheme for alternative scheme 1, alternative scheme 2, and alternative scheme 3, respectively. From the societal perspective, when compared with the current scheme, the budgetary impact of the three alternative schemes were +66 million Chinese Yuan (CNY) (4.81%), +103 million CNY (7.53%), and +305million CNY (22.35%), respectively. The CMA considered a broader perspective of social costs and indicated that the alternative schemes would result in an overall saving of parents' transportation and work loss costs to bring their children for vaccination, translating into a total cost saving of 18.18%, 36.36%, 63.64%, comparing to the current scheme. Thus, fully or partly using the DTaP-IPV-Hib combination vaccine is cost-saving in the context of China.
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Haemophilus influenzae tipo b , Niño , Humanos , Lactante , Estudios Transversales , Vacunas Combinadas , Costos y Análisis de Costo , ChinaRESUMEN
INTRODUCTION: PENTAXIM™ (Sanofi), DTaP-IPV//Hib, a pentavalent combination vaccine for protection against diphtheria, tetanus, pertussis, poliomyelitis, and invasive infections caused by Haemophilus influenzae type b, has been licensed in South Korea by the Ministry of Food and Drug Safety (MFDS) on May 9, 2016, and is currently used in routine vaccination. The aim of this phase IV study, conducted as a post-licensure commitment in South Korea, was to evaluate the safety of the DTaP-IPV//Hib vaccine when administered in infants at 2, 4, and 6 months of age in the real-world clinical practice. METHODS: This multicenter, observational, post-marketing surveillance (PMS) study was conducted in real-world practice in South Korea. Infants aged 2 months or older were enrolled across seven centers from July 31, 2018 to February 11, 2020. The study outcomes included occurrence, time to onset, duration, intensity, and causality assessment (for unsolicited adverse events [AEs] only) for several pre-listed solicited injection-site and systemic reactions, unsolicited AEs, and serious adverse events (SAEs). RESULTS: Data from 619 participants were included in the safety analysis. Overall, 618 AEs were reported by 273 (44.1%) participants consisting of 121 solicited injection-site reactions (15.4%), 344 solicited systemic reactions (24.6%), and 153 unsolicited AEs (15.7%) of which, 124 were unexpected AEs (12.9%) (regardless of intensity). None of the unsolicited AEs were reported to have a causal relationship with the study vaccine. One SAE of pyrexia (solicited reaction) was reported. Most AEs were of mild intensity, and all participants recovered. CONCLUSION: This PMS study of the DTaP-IPV//Hib vaccine confirmed its safety profile in a real-life setting in South Korea and justified that the vaccine is well tolerated when used in infants aged 2 months or older for the primary series.
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ObjectiveTo determine the reporting rate of adverse reaction of Haemophilus influenzae type b （Hib） containing vaccine in Songjiang District from 2016 to 2020， so as to provide evidence for the inclusion of Hib vaccine in children's immunization planning and safety monitoring. MethodsThe adverse reaction data of Hib vaccination were collected through the Chinese Disease Prevention and Control Information System and presented by descriptive methods. ResultsFrom 2016 to 2020， the reporting rate of adverse reaction of various Hib-containing vaccines in Songjiang District was determined to be 747.76/105 doses， among which the rates of general reaction and abnormal reaction were 734.31/105 doses and 13.45/105 doses， respectively. The reporting rate of general reaction was significantly higher than that of abnormal reaction （χ2=1 400.18，P<0.001）. Moreover， the reporting rate of adverse reaction did not differ significantly by sex or registered residence， whereas it differed significantly by age groups （χ2=366.07，P<0.001）. Children ≥12 months old had the highest reporting rate， which was caused by higher rate of general reaction （χ2=360.48，P<0.001） compared with other age groups； in contrast， there was no difference in the reporting rate of abnormal reactions across age groups. The reporting rate of adverse reaction differed significantly across four Hib-containing vaccines （χ2=508.51，P<0.001）， among which the reporting rate of pentavalent vaccine was the highest， followed by tetravalent vaccine， and Hib vaccine and meningococcal HI vaccine. This difference was mainly caused by general reaction （χ2=499.19，P<0.001）. The reporting rate of booster Hib-containing vaccines was significantly higher than that of basic immunization （χ2=462.85，P<0.001）. Furthermore， the reporting rate differed between DTaP-Hib vaccine and DTaP-IPV-Hib vaccine by injection sites（χ2=13.63，P=0.001；χ2=78.48， P<0.001）； the reporting rate on the thigh was lower than that on the hip or upper arm. Among the 1 501 reported adverse reactions， 97.21% of the general reactions and 85.19% of the abnormal reactions occurred within 72 hours following immunization. Principal clinical diagnosis was fever， redness and nodules （n=1 454）， accounting for 96.87% of the total reported adverse event following immunization（AEFI）， followed by allergic rash. ConclusionThe four types of Hib-containing vaccines have high safety. Health care practitioners at points of vaccination should improve the pre-examination， standardized operation and full notification in strict accordance with the requirements. It also warrants strengthening the AEFI monitoring， investigation and response， so as to effectively reduce the incidence and severity of adverse reactions.
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Vaccine co-administration can facilitate the introduction of new vaccines in immunisation schedules and improve coverage. We analysed real life data to quantify the extent of routine paediatric vaccine co-administrations as recommended and as never recommended in the immunisation schedule in England, and assessed factors for recommended and never recommended vaccine co-administrations. Immunisation data for all scheduled routine paediatric vaccines between 2008 and 2018 was obtained from the Royal College of General Practitioners (RCGP) Research and Surveillance Centre (RSC). We included 6'257'828 doses administered to 1'005'827 children. Twenty-one percent of vaccines were given separately, 79% were co-administered. Sixty-four percent of vaccines scheduled for co-administration were co-administered as recommended while 15% were administered separately. Among all vaccine co-administrations, 75% happened as recommended in the schedule, 4% were never recommended, while 21% deviated from the schedule. Vaccine co-administration according to the schedule varied greatly between vaccines. Forty-eight percent of English children received at least one of their vaccine co-administrations not as recommended in the immunisation schedule, with 19% of children receiving none of their co-administered vaccines as recommended. Late administration of one or more vaccines increased the odds for deviated co-administrations (OR 1.60) and strongly increased the odds for never recommended co-administrations (OR 5.34). Differences between genders, NHS regions, and IMD quintiles were statistically significant but small. Suboptimal co-administration rates for routine paediatric vaccines are a missed opportunity and should be optimised by concerted public health action.
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BACKGROUND: DTaP-IPV-Hib-HepB is a fully-liquid, hexavalent combination vaccine (Vaxelis™) approved for vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, and invasive disease due to Haemophilus influenzae type b (Hib). Hib capsular polysaccharide, polyribosylribitol phosphate (PRP), is conjugated to Neisseria meningitidis outer membrane protein complex (OMPC). Safety and immunogenicity of DTaP-IPV-Hib-HepB were evaluated in 6 Phase III clinical studies including > 5,200 children. Studies included vaccination schedules in the United States (2, 4, 6 months of age) and Europe (2, 3, 4, 12 months of age and 2,4,11-12 months of age). METHODS: Data pertaining to anti-PRP responses of DTaP-IPV-Hib-Hep B compared to control vaccines from 5 Phase III studies are summarized. RESULTS: Post-infant series, the percentage of participants that achieved protective antibody thresholds for PRP (anti-PRP titer ≥ 0.15 µg/mL and ≥ 1.0 µg/mL, respectively) were higher in DTaP-IPV-Hib-HepB recipients compared to recipients who received control vaccines. A high level of protective responses (96.6% at ≥ 0.15 µg/mL [95% CI:94.8, 97.9%]; 72.9% at ≥ 1.0 µg/mL [95% CI:69.2,76.4%]) were seen post-dose 2 of the 2 + 1 vaccination schedule and met superiority criteria over comparator, p-value < 0.001. In the same schedule, prior to administration of the toddler dose (in the second year of life), anti-PRP titers were higher in DTaP-IPV-Hib-HepB recipients (91.4% at ≥ 0.15 µg/mL; 46.8% at ≥ 1.0 µg/mL) as compared to recipients who received control vaccines (63.4% at ≥ 0.15 µg/mL; 17.1% at ≥ 1.0 µg/mL). One-month post-toddler dose, high levels of anti-PRP titers were achieved in both DTaP-IPV-Hib-HepB recipients (99.8% at ≥ 0.15 µg/mL; 96.6% at ≥ 1.0 µg/mL) and recipients who received control vaccines (99.5% at ≥ 0.15 µg/mL; 94.9% at ≥ 1.0 µg/mL). CONCLUSIONS: These results support that DTaP-IPV-Hib-HepB induces a robust and sustained early Hib response. During the high-risk period for Hib disease after the infant vaccine and prior to the toddler dose; >90% of recipients maintained superior protective anti-PRP levels compared to control.
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Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Gripe Humana , Anticuerpos Antibacterianos , Vacuna contra Difteria, Tétanos y Tos Ferina , Europa (Continente) , Vacunas contra Hepatitis B , Humanos , Inmunidad , Lactante , Vacuna Antipolio de Virus Inactivados , Vacunas Combinadas , Vacunas ConjugadasRESUMEN
Background: Immune immaturity may put premature infants at increased risk for infections. DTaP-IPV-Hib-HepB vaccine (Vaxelis™), a hexavalent vaccine studied in >6,800 children, has acceptable safety and immunogenicity profiles generally similar to control vaccines. Here we evaluate safety and immunogenicity of DTaP-IPV-Hib-HepB vaccine in premature infants. Methods: Premature infants were identified using prior medical conditions terms "premature baby/delivery" and/or "low birth weight baby". Immunogenicity and safety data were summarized across one Phase II and four Phase III randomized, active-comparator-controlled clinical trials (Protocol 004 in Canada [Control: PENTACEL™]; Protocols 005 and 006 in the US [Control: PENTACEL™]; and Protocols 007 and 008 in the EU [Control: INFANRIX™ hexa]) and one Phase III clinical trial in the UK (PRI01C); no formal statistical comparisons were performed. Results: Overall, 160 infants were considered premature (DTaP-IPV-Hib-HepB = 111 Control = 49). The incidence of adverse events (AEs) for DTaP-IPV-Hib-HepB was comparable between overall and premature populations for all AEs days 1-15 postvaccination (Overall = 96.3%; Premature = 97.3%;), solicited injection-site AEs days 1-5 postvaccination (Overall = 84.1%; Premature = 75.5%), and solicited systemic AEs days 1-5 postvaccination (Overall = 93.7%; Premature = 94.5%). A high percentage of premature infants mounted protective immune responses to antigens contained in DTaP-IPV-Hib-HepB vaccine. Response rates in preterm infants for all antigens (80-99%) were in a similar range to all infants (80-99%) for both DTaP-IPV-Hib-HepB and control vaccines. Conclusions: DTaP-IPV-Hib-HepB vaccine has a low incidence of AEs, an acceptable safety profile, and elicited satisfactory immune responses in premature infants comparable to the overall study population. These findings support vaccination with DTaP-IPV-Hib-HepB vaccine in healthy premature infants.
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Vacunas contra Haemophilus , Haemophilus influenzae tipo b , Anticuerpos Antibacterianos , Canadá , Niño , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B , Humanos , Lactante , Recién Nacido de Bajo Peso , Recién Nacido , Recien Nacido Prematuro , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vacunas Combinadas/efectos adversosRESUMEN
BACKGROUND: The DTaP-IPV/Hib combination vaccine can replace the acellular tetanus vaccine, polio vaccine, and the Haemophilus influenzae type B vaccine. Data on the safety of DTaP-IPV/Hib vaccines are required. We aimed to evaluate the safety of the vaccination program. METHODS: Using the National Adverse Events Following Immunization (AEFI) surveillance system (CNAEFIS) in Guangzhou, China, a retrospective study was performed from May 11, 2011, to December 31, 2017. There were 376 cases of adverse events after vaccination with the DTaP IPV/Hib vaccine. The primary analysis indicators were the number of vaccines used, the number of AEFI reports received, and the reporting rate (per 100,000). RESULTS: From May 1, 2011, to December 31, 2017, 516,000 doses of vaccine were inoculated, and 376 cases of adverse reactions were reported; the reporting rate was 72.8 per 100,000 vaccines. There were eight cases of serious AEFIs (1.5 per 100,000), with four cases of thrombocytopenic purpura (0.8 per 100,000); three cases of cyanosis of the lips, stiffness, and flexion of limbs, and convulsions (0.6 per 100,000); and one case of a high fever (0.2 per 100,000). The highest incidence of AEFIs occurred after the fourth dose (n = 207, 55.0%, 40.1 per 100,000), followed by the first dose (n = 81, 21.5%, 15.7 per 100,000), second dose (n = 48, 12.8%, 9.3 per 100,000) and third dose (n = 40, 10.6%, 7.7 per 100,000). The AEFI incidence was higher after injection of the vaccine into the deltoid muscle of the upper arm (n = 276, 73.4%, 53.5 per 100,000) than after injection of the vaccine into the thigh (n = 100, 26.6%, 19.4 per 100,000). There was a significant difference between AEFIs after injection into the deltoid of the upper arm deltoid and the thigh (x2 = 164.8, P < 0.05). CONCLUSIONS: Most of the reported AEFIs after DTaP-IPV/Hib vaccination are not serious. There were four cases of TP in this study; vaccination may be a rare cause of thrombocytopenic purpura.
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Vacuna contra Difteria, Tétanos y Tos Ferina/farmacología , Vacunas contra Haemophilus/farmacología , Vacuna Antipolio de Virus Inactivados/farmacología , China , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Femenino , Vacunas contra Haemophilus/efectos adversos , Haemophilus influenzae tipo b/inmunología , Humanos , Lactante , Masculino , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vigilancia de Productos Comercializados , Púrpura Trombocitopénica/inducido químicamente , Estudios Retrospectivos , Tétanos/prevención & control , Vacunas Conjugadas/efectos adversos , Vacunas Conjugadas/farmacologíaRESUMEN
Using electronic health records, we assessed the early impact of coronavirus disease (COVID-19) on routine childhood vaccination in England by 26 April 2020. Measles-mumps-rubella vaccination counts fell from February 2020, and in the 3 weeks after introduction of physical distancing measures were 19.8% lower (95% confidence interval: -20.7 to -18.9) than the same period in 2019, before improving in mid-April. A gradual decline in hexavalent vaccination counts throughout 2020 was not accentuated by physical distancing.
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Infecciones por Coronavirus/epidemiología , Coronavirus , Brotes de Enfermedades/prevención & control , Vacuna contra el Sarampión-Parotiditis-Rubéola , Pandemias , Neumonía Viral/epidemiología , Vacunación/estadística & datos numéricos , Betacoronavirus , COVID-19 , Preescolar , Inglaterra , Accesibilidad a los Servicios de Salud , Humanos , Lactante , Sarampión/prevención & control , Paperas/prevención & control , Cuarentena , Rubéola (Sarampión Alemán)/prevención & control , SARS-CoV-2RESUMEN
BACKGROUND: If immune responses to vaccination differ between males and females, sex-specific vaccination schedules may be indicated. We systematically reanalysed childhood vaccination studies conducted in The Netherlands for sex-differences in IgG-responses. To assess the impact of potential sex-differences in IgG-responses, we explored sex-differences in vaccine failure/effectiveness and reactogenicity. METHODS: Six studies with IgG-measurements for 1577 children following infant pneumococcal (PCV7/PCV10/PCV13) and/or DTaP-IPV-Hib(-HepB) vaccinations, or the pre-school DTaP-IPV booster were included. We performed one-stage individual participant data meta-analyses per time-point of the effect of sex on IgG levels against pneumococcal serotypes, diphtheria toxoid, tetanus toxoid, pertussis Ptx/FHA/Prn and Hib-PRP using linear mixed models. Using existing study data, we compared reactogenicity after PCV7/PCV10 and DTaP-IPV-Hib(-HepB) vaccination in girls and boys. Vaccine failure/effectiveness was compared between girls and boys for invasive pneumococcal disease (IPD), invasive Hib disease and pertussis using notification data. RESULTS: For pneumococcal vaccination, the geometric mean concentration ratio of IgG levels in girls versus boys pooled across serotypes was 1.15 (95%CI 0.91-1.45) 1â¯month following the primary series, 1.16 (1.02-1.32) at age 8â¯months, 1.12 (1.02-1.23) pre-booster (age 11â¯months) and 0.99 (0.89-1.10) post-booster (age 12â¯months). Diphtheria toxoid, tetanus toxoid, pertussis Ptx/FHA/Prn and Hib-PRP IgG levels did not differ between girls and boys, except for Hib post-booster (1.24; 95%CI 1.01-1.52) and tetanus before pre-school booster (0.71; 0.53-0.95). We found no difference between boys and girls in reactogenicity at age 4 or 11â¯months or in vaccine failure/effectiveness for IPD, invasive Hib disease or pertussis. CONCLUSION: For most vaccine antigens investigated, there were no consistent differences in vaccine-induced IgG levels. Vaccine-induced pneumococcal IgG levels were slightly higher in girls, but only between the primary series and the 11-month booster. These results, along with similar reactogenicity and vaccine failure/effectiveness, support the uniform infant vaccination schedule in the Dutch national immunisation programme.
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Anticuerpos Antibacterianos/sangre , Vacuna contra Difteria, Tétanos y Tos Ferina/inmunología , Vacunas contra Haemophilus/inmunología , Vacunas contra Hepatitis B/inmunología , Inmunoglobulina G/sangre , Vacunas Neumococicas/inmunología , Vacuna Antipolio de Virus Inactivados/inmunología , Factores Sexuales , Preescolar , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Femenino , Infecciones por Haemophilus/epidemiología , Infecciones por Haemophilus/prevención & control , Vacunas contra Haemophilus/administración & dosificación , Vacunas contra Haemophilus/efectos adversos , Vacunas contra Hepatitis B/administración & dosificación , Vacunas contra Hepatitis B/efectos adversos , Humanos , Lactante , Masculino , Países Bajos , Infecciones Neumocócicas/epidemiología , Infecciones Neumocócicas/prevención & control , Vacunas Neumococicas/administración & dosificación , Vacunas Neumococicas/efectos adversos , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Vacuna Antipolio de Virus Inactivados/efectos adversos , Insuficiencia del Tratamiento , Vacunas Combinadas/administración & dosificación , Vacunas Combinadas/efectos adversos , Vacunas Combinadas/inmunología , Tos Ferina/epidemiología , Tos Ferina/prevención & controlRESUMEN
BACKGROUND: The combination DTaP-IPV/Hib vaccine was licensed in the United States in 2008 for children ages 6weeks through 4years with doses administered at 2, 4, 6, and 15-18months of age. The aim of this study was to assess the safety of DTaP-IPV/Hib vaccine routinely administered as part of clinical care to infants at Kaiser Permanente Northern California. METHODS: This was an observational, retrospective study that included all 2-month-old infants vaccinated with either DTaP-IPV/Hib or another DTaP-containing vaccine. We monitored all subjects for non-elective hospitalizations, emergency department visits and selected outpatient outcomes (seizures, Guillain-Barré Syndrome, encephalopathy, encephalitis, alteration of consciousness, meningitis, hypersensitivity reactions, immune thrombocytopenic purpura, hemolytic anemia, type 1 diabetes, and Kawasaki disease) beginning with their first dose through 6months after a 4th dose or until 24months of age. We calculated incidence rate ratios (IRRs) in the primary analysis by comparing rates of outcomes during the post-vaccination risk interval with rates during a comparison interval more remote from vaccination. Secondary analyses compared outcomes after DTaP-IPV/Hib with those after other DTaP-containing vaccines. We reviewed the medical records of selected outcomes. RESULTS: From October 1, 2008 through July 31, 2010, 14,042 subjects received a first dose of DTaP-IPV/Hib, 13,194 received 2 doses, 12,548 received 3 doses and 6702 received 4 doses. Overall, there were 166 comparisons with significantly elevated IRRs and 165 comparisons with significantly reduced IRRs. Medical record review of outcomes with significantly elevated IRRs in both the primary and secondary analyses did not suggest any relationship with DTaP-IPV/Hib. CONCLUSIONS: This study did not detect any safety concerns following DTaP-IPV/Hib and provides reassurance that DTaP-IPV/Hib administered as part of routine care was not associated with unexpected safety risks. ClinicalTrials.gov Identifier: NCT00804284.
Asunto(s)
Vacuna contra Difteria, Tétanos y Tos Ferina/efectos adversos , Vacunas contra Haemophilus/efectos adversos , Vacuna Antipolio de Virus Inactivados/efectos adversos , Vigilancia de Productos Comercializados , Vacunación/efectos adversos , California , Preescolar , Vacuna contra Difteria, Tétanos y Tos Ferina/administración & dosificación , Femenino , Vacunas contra Haemophilus/administración & dosificación , Humanos , Inmunización Secundaria , Lactante , Masculino , Vacuna Antipolio de Virus Inactivados/administración & dosificación , Estudios Retrospectivos , Medición de Riesgo , Vacunas Conjugadas/administración & dosificación , Vacunas Conjugadas/efectos adversosRESUMEN
Ontario has a single payer provincial health insurance program. Administrative data may provide a potentially robust source of information for post-marketing vaccine studies. Vaccine-specific immunization billing codes were introduced in 2011. Our objective was to validate Ontario's universal health care administrative datasets to assess infant immunization status. Electronic medical record data from the Electronic Medical Record Administrative data Linked Database (EMRALD) was used as the reference standard to calculate performance characteristics of the Ontario Health Insurance Plan (OHIP) database vaccine-specific and general immunization codes for 4 primary infant immunizations: diphtheria, tetanus, acellular pertussis, inactivated polio, Haemophilus influenzae type B (DTaP-IPV-Hib) combination vaccine, pneumococcal conjugate vaccine, measles, mumps, rubella (MMR) vaccine, and meningococcal conjugate serogroup C vaccine. OHIP billing claims had specificity ranging from 81% to 92%, sensitivity 70% to 83%, positive predictive value (PPV) 97% to 99%, and negative predictive value (NPV) 13% to 46% for identifying the various specific vaccines in administrative data. For cohorts vaccinated in the new code introduction phase, using both the vaccine-specific and general codes had higher sensitivity than the vaccine-specific codes alone. In conclusion, immunization billing claims from administrative data in Ontario had high specificity and PPV, moderate sensitivity, and low NPV. This study identifies some of the applications of utilizing administrative data for post-marketing vaccine studies. However, limitations of these data decrease their utility for measuring vaccine coverage and effectiveness. Therefore, the establishment of a comprehensive and linkable immunization registry should be a provincial priority.