Tam John S, Capeding Maria Rosario Z, Lum Lucy Chai See, Chotpitayasunondh Tawee, Jiang Zaifang, Huang Li-Min, Lee Bee Wah, Qian Yuan, Samakoses Rudiwilai, Lolekha Somsak, Rajamohanan K Pillai, Narayanan S Noel, Kirubakaran Chellam, Rappaport Ruth, Razmpour Ahmad, Gruber William C, Forrest Bruce D
Department of Microbiology and Faculty of Medicine, The Chinese University of Hong Kong, Shatin, Hong Kong.
Pediatr Infect Dis J. 2007 Jul;26(7):619-28. doi: 10.1097/INF.0b013e31806166f8.
This study was designed to evaluate the efficacy and safety of cold-adapted influenza vaccine, trivalent (CAIV-T) against culture-confirmed influenza in children 12 to <36 months of age during 2 consecutive influenza seasons at multiple sites in Asia.
In year 1, 3174 children 12 to <36 months of age were randomized to receive 2 doses of CAIV-T (n = 1900) or placebo (n = 1274) intranasally > or =28 days apart. In year 2, 2947 subjects were rerandomized to receive 1 dose of CAIV-T or placebo.
Mean age at enrollment was 23.5 +/- 7.4 months. In year 1, efficacy of CAIV-T compared with placebo was 72.9% [95% confidence interval (CI): 62.8-80.5%] against antigenically similar influenza subtypes, and 70.1% (95% CI: 60.9-77.3%) against any strain. In year 2, revaccination with CAIV-T demonstrated significant efficacy against antigenically similar (84.3%; 95% CI: 70.1-92.4%) and any (64.2%; 95% CI: 44.2-77.3%) influenza strains. In year 1, fever, runny nose/nasal congestion, decreased activity and appetite, and use of fever medication were more frequent with CAIV-T after dose 1. Runny nose/nasal congestion after dose 2 (year 1) and dose 3 (year 2) and use of fever medication after dose 3 (year 2) were the only other events reported significantly more frequently in CAIV-T recipients.
CAIV-T was well tolerated and effective in preventing culture-confirmed influenza illness over multiple and complex influenza seasons in young children in Asia.
本研究旨在评估三价冷适应流感疫苗（CAIV-T）在亚洲多个地点连续两个流感季节对12至小于36月龄儿童确诊流感的有效性和安全性。
在第1年，3174名12至小于36月龄儿童被随机分组，鼻内接种2剂CAIV-T（n = 1900）或安慰剂（n = 1274），间隔≥28天。在第2年，2947名受试者重新随机分组，接种1剂CAIV-T或安慰剂。
入组时的平均年龄为23.5±7.4个月。在第1年，与安慰剂相比，CAIV-T对抗抗原性相似流感亚型的有效性为72.9%[95%置信区间（CI）：62.8 - 80.5%]，对抗任何毒株的有效性为70.1%（95%CI：60.9 - 77.3%）。在第2年，再次接种CAIV-T对对抗抗原性相似（84.3%；95%CI：70.1 - 92.4%）和任何（64.2%；95%CI：44.2 - 77.3%）流感毒株均显示出显著有效性。在第1年，第1剂CAIV-T接种后，发热、流鼻涕/鼻塞、活动和食欲下降以及使用退烧药的情况更为常见。第2剂（第1年）和第3剂（第2年）接种后的流鼻涕/鼻塞以及第3剂（第2年）接种后使用退烧药是CAIV-T接种者中报告的仅有的其他显著更频繁出现的事件。
在亚洲幼儿中，CAIV-T在多个复杂流感季节预防确诊流感疾病方面耐受性良好且有效。
