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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.

UNASSIGNED: 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.
UNASSIGNED: To explain how the introduction of DTaP-IPV/Hib in the NIP has changed vaccination practices for infants.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.

DTaP-HBV-IPV-Hib hexavalent vaccine has been used in high-income countries for many years to prevent diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and invasive Haemophilus influenzae type b disease. Currently, no hexavalent vaccines have been approved for use in China. Evidence of parental acceptance and interest in hexavalent vaccines can help policy makers and manufacturers make decisions about entering the vaccine market and the immunization program in China. We measured parental acceptance and willingness-to-pay (WTP) for a hexavalent vaccine to provide such evidence. We conducted a cross-sectional survey of children\'s caregivers in 16 vaccination clinics in seven cities in China and obtained information on socio-demographics, knowledge of disease, confidence in vaccines, previous vaccination experience, and acceptance of and WTP for hexavalent vaccine. Multivariate logistic regression was used to determine factors influencing acceptance, and multivariate tobit regression was used to identify factors impacting WTP. Between April 28 and June 30, 2023, a total of 581 parents of children aged 0-6 years participated in the survey; 435 (74.87%, 95% CI:71.3%-78.4%) parents indicated acceptance of hexavalent vaccine. Residence location, parents\' education level, experience paying for vaccination, and disease knowledge scores were key factors affecting parents\' choices for vaccination. Mean (SD) and median (IQR) willingness to pay for full 4-dose course vaccination were 2266.66 (1177.1) CNY and 2400 (1600-2800) CNY. Children\'s age (p < .001), parents\' education level (p = .024), and perceived price barriers (p < .001) were significantly associated with WTP. Parents have high acceptance and willingness to pay for hexavalent vaccine. The less money parents have to pay out of pocket, the more willing they can be to accept the vaccine. Therefore, acceptance may increase even further if the vaccine is covered by medical insurance, provided free of charge by the government, or if its price is reduced. Our results provide reference for optimizing and adjusting immunization strategies in China.

Many countries have adopted higher-valent pediatric combination vaccines to simplify vaccination schedules and minimize health expenditures and social costs. However, China is conservative in the use of pediatric combination vaccines. By reviewing and synthesizing quantitative and qualitative data, in this commentary we identify gaps and challenges to combination vaccine use and make recommendations for promoting use of higher-valent pediatric combination vaccines in China. Challenges are in four dimensions: (1) legislation and regulation, (2) immunization schedule design, (3) vaccine awareness and price, and (4) research and development capacity. To optimize the use of combination vaccines to reduce vaccine-preventable disease burden, we make recommendations that address key challenges: (1) develop policies and regulations to strengthen enforcement of the Vaccine Administration Law and remove regulatory hurdles that hinder combination vaccine research and development, (2) establish an evidence-informed policy-making mechanism for combination vaccines, (3) resolve immunization schedule conflicts between monovalent and combination vaccines, and (4) implement effective interventions to increase vaccine awareness and reduce price.

combination vaccines can improve timely vaccination coverage and mitigate the social and economic burdens of both caregivers and health systems. Compared to other countries with high immunization performance, China remains behind the curve in promoting the inclusion of new combination vaccines into national vaccination schedules. The domestic research and development pipeline faces many technical obstacles, regulatory pressures, and competitive opposition. In addition to this, health disparities regarding combination vaccines exist in each dimension of access and their determinants, including availability, accessibility, acceptability, and quality. Our study aims to provide a cross-disciplinary analysis of China\'s combination vaccines (from innovation to access) and identify the main factors that affect the attitudes and behavior choices for combination vaccines.
systematic reviews and secondary data analysis will be conducted to map the landscape of combination vaccines in China and the determinants influencing their innovation and access. A cross-sectional survey will be performed in seven provinces of China based on geo-economic representativeness among caregivers with children that are between 2 and 24 months old and are registered in the national immunization system. Questionnaires will be used to examine the relationship between each dimension of access and their determinants. These questionnaires will cover the caregivers\' knowledge, attitude, and willingness to pay for combination vaccines, as well as their perceptions about vaccination services. Semi-structured interviews with the suppliers (public and private) and healthcare providers will help identify research gaps and the key challenges they face when developing and introducing combination vaccines in China.
using a combined approach, with cross-country and multi-disciplinary support from experts, our research is designed to fill the information gaps in China\'s combination vaccine industry across the innovation-access spectrum. It will lead to evidence-based recommendations which will foster greater access to innovation-enhancing combination vaccines for childhood immunization in China. Moreover, the multi-dimensional approach could also be adapted beyond combination vaccines to assess innovation and other public goods for health among disadvantaged groups in the future.

UNASSIGNED: Combination vaccines reduce the number of pediatric injections but must be as safe, immunogenic, and effective as each of the individual vaccines given separately. Additionally, consistency in manufacturing lots is essential for WHO prequalification. This study aimed to establish the lot-to-lot consistency of a fully liquid, hexavalent diphtheria (D)-tetanus (T)-whole-cell pertussis (wP)-inactivated poliovirus (IPV)-hepatitis B (HB)-Haemophilus influenzae b (PRP-T) (DTwP-IPV-HB-PRP∼T) vaccine and to demonstrate non-inferiority to licensed DTwP-HB-PRP∼T and IPV vaccines.
UNASSIGNED: A Phase III, randomized, active-controlled, and open-label study was conducted at multiple centers across India. Healthy infants who had received a birth dose of oral poliovirus vaccine and hepatitis B vaccine received one of three lots of DTwP-IPV-HB-PRP∼T or separate DTwP-HB-PRP∼T and IPV vaccines at 6-8, 10-12, and 14-16 weeks of age. Oral rotavirus vaccine was co-administered at 6-8 weeks of age and 10-12/14-16 weeks of age. DTwP-IPV-HB-PRP∼T lot-to-lot consistency and non-inferiority (pooled DTwP-IPV-HB-PRP∼T) versus DTwP-HB-PRP∼T and IPV post-third dose were assessed using seroprotection rates (anti-D, anti-T, anti-HBs, anti-PRP, anti-polio 1, 2, 3) and adjusted geometric mean concentrations (anti-PT, anti-FIM). Safety was assessed by parental reports.
UNASSIGNED: Lot-to-lot consistency was demonstrated for DTwP-IPV-HB-PRP∼T and non-inferiority versus DTwP-HB-PRP∼T and IPV was confirmed with 95% CIs for seroprotection rate differences and adjusted geometric mean concentration ratios within pre-defined clinical margins. Pooled seroprotection rate was ≥ 99.7% for anti-D ≥ 0.01 IU/mL, anti-T ≥ 0.01 IU/mL, anti-HBs ≥ 10 mIU/mL, anti-PRP ≥ 0.15 µg/mL, and anti-polio 1, 2, and 3 ≥ 8 (1/dil) and vaccine response rate was 83.9% for anti-PT and 97.7% for anti-FIM. There were no safety concerns.
UNASSIGNED: Immunogenicity of three lots of the fully liquid DTwP-IPV-HB-PRP∼T vaccine was consistent and non-inferior to licensed comparators following vaccination at 6-8, 10-12, and 14-16 weeks of age. There were no safety concerns and no evidence of any effect of co-administration with rotavirus vaccine.

Goatpox, sheeppox, and peste-des-petits-ruminants (PPR) are economically important virus diseases affecting goats and sheep, which often cause coinfection/comorbidities in the field. Coinfection with these viruses leads to enhanced infection in natural scenarios in terms of morbidities and mortalities. Currently, individual live attenuated vaccines are being used to mitigate these diseases and research on combination vaccines for these diseases is encouraging. For the preparation of combination vaccines, vaccine strains of the peste-des-petits-ruminants virus (PPRV), goatpox virus (GTPV), and sheeppox virus (SPPV) are grown separately and GTPV + PPRV are mixed for vaccination of goats, and PPRV + SPPV for sheep. Growing capripox and PPRV strains in the same cells simultaneously without the titer loss will save the time and cost of production. In the current study, we have evaluated the coinfection kinetics of capripox virus and a PPRV using a candidate GTPV vaccine strain (originally caused infection in both goats and sheep in the field) and PPRV/Sungri/96 (vaccine strain) in Vero cells. At high multiplicity of infection (MOI), PPRV was excluded from coinfection by GTPV, whereas at a low multiplicity coexistence/accommodation was observed between PPRV and GTPV without loss of the titer. The results shed light on the possibility of the production of two vaccine strains in the same cells using the coinfection model economically.