Kemmeren Jeanet M, van der Maas Nicoline At, de Melker Hester E
Center for Infectious Disease Control, National Institute for Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands.
Eur J Pediatr. 2017 Jun;176(6):757-768. doi: 10.1007/s00431-017-2901-4. Epub 2017 Apr 20.
In 2011, the 7-valent conjugated pneumococcal vaccine (PCV7) was replaced by the 10-valent vaccine (PCV10) and universal hepatitis B vaccination has been introduced in the Netherlands. A questionnaire study was conducted to assess the tolerability of DTaP-IPV-Hib + PCV7 (PCV7-cohort), DTaP-IPV-Hib + PCV10 (PCV10-cohort), and DTaP-IPV-Hib-HepB + PCV10 (HepB-cohort). Parents were asked to report in questionnaires local reactions and systemic adverse events (AEs) before and after vaccination of their infant at 2, 3, 4, and 11 months of age. For 29.0 and 29.4% infants of the PCV7-cohort, at least one local reaction was reported in the week after the first dose of DTaP-IPV (left leg) and PCV-7 vaccination (right leg). Significantly more infants from the PCV10-cohort (45.1%, p < 0.001 and 44.6%, p < 0.001) and HepB-cohort (42.6%, p < 0.001 and 41.9%, p < 0.001) reported at least one local reaction. This effect was less pronounced after the successive doses. Most of the infants experienced at least one systemic AE, and after dose 4, this was higher for infants in the PCV10-cohort (65.9%, p = 0.047) and HepB-cohort (70.6%, p = 0.000) compared to the PCV7-cohort (62.3%).
Addition of antigens to a vaccine resulted in a higher reactogenicity, but the AEs were in general mild and transient. What is Known: • Assessment of adverse events is crucial for achieving the highest safety in immunization programs, in order to inform public health actions and maintain public confidence in immunization programs. What is New: • Newly introduced vaccines DTaP-IPV-Hib-HepB and PCV10 are generally safe and well tolerated in infants. • These results are useful for information purposes and for monitoring variations in rates of AEs in the general population or in the target group over time.
2011年，荷兰用10价疫苗（PCV10）取代了7价结合肺炎球菌疫苗（PCV7），并引入了乙型肝炎普遍接种计划。开展了一项问卷调查研究，以评估白喉破伤风无细胞百日咳灭活脊髓灰质炎b型流感嗜血杆菌联合疫苗+PCV7（PCV7队列）、白喉破伤风无细胞百日咳灭活脊髓灰质炎b型流感嗜血杆菌联合疫苗+PCV10（PCV10队列）以及白喉破伤风无细胞百日咳灭活脊髓灰质炎b型流感嗜血杆菌乙型肝炎联合疫苗+PCV10（乙型肝炎队列）的耐受性。要求家长在问卷中报告其婴儿在2、3、4和11月龄接种疫苗前后的局部反应和全身不良事件（AE）。PCV7队列中分别有29.0%和29.4%的婴儿在接种第一剂白喉破伤风无细胞百日咳灭活脊髓灰质炎疫苗（左腿）和PCV-7疫苗（右腿）后的一周内报告至少出现了一种局部反应。PCV10队列（分别为45.1%，p<0.001和44.6%，p<0.001）和乙型肝炎队列（分别为42.6%，p<0.001和41.9%，p<0.001）中报告至少出现一种局部反应的婴儿明显更多。在后续接种后，这种影响不那么明显。大多数婴儿至少经历了一种全身AE，在第4剂接种后，PCV10队列（65.9%，p=0.047）和乙型肝炎队列（70.6%，p=0.000）中婴儿出现全身AE的比例高于PCV7队列（62.3%）。
在疫苗中添加抗原会导致更高的反应原性，但不良事件一般较轻且为一过性。已知信息：•评估不良事件对于在免疫规划中实现最高安全性至关重要，以便为公共卫生行动提供信息并维持公众对免疫规划的信心。新发现：•新引入的疫苗白喉破伤风无细胞百日咳灭活脊髓灰质炎b型流感嗜血杆菌乙型肝炎联合疫苗和PCV10在婴儿中总体上安全且耐受性良好。•这些结果有助于提供信息，并用于监测一般人群或目标群体中不良事件发生率随时间的变化。
