Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old
Phase 2 evaluation of parainfluenza type 3 cold passage mutant 45 live attenuated vaccine in healthy children 6-18 months old
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DOI：
10.1086/381184
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发表时间：
2004-02-01
影响因子：
6.4
通讯作者：
Anderson, E
中科院分区：
文献类型：
--
作者：
Belshe, RB;Newman, FK;Anderson, E
在380名6 - 18月龄儿童中进行了3型副流感病毒（PIV 3）减毒活疫苗-冷传代突变体45（cp 45）疫苗的II期评价; 226名儿童（59%）的PIV 3血清阴性。在226名血清阴性儿童中，114名接受了PIV 3-cp 45疫苗，112名接受了安慰剂。不良事件发生率无显著差异（即，流鼻涕、咳嗽或体温大于或等于38 ℃）。两组急性中耳炎或浆液性中耳炎的发生率无差异。109名血清阴性疫苗接种者和110名血清阴性安慰剂接种者的配对血清样本可用; 84%的血清阴性疫苗接种者的抗体滴度增加大于或等于4倍。疫苗组接种后抗体滴度几何平均值为1：25，
A phase 2 evaluation of live attenuated parainfluenza type 3 (PIV3) -cold passage mutant 45 (cp45) vaccine was conducted in 380 children 6 - 18 months old; 226 children (59%) were seronegative for PIV3. Of the 226 seronegative children, 114 received PIV3-cp45 vaccine, and 112 received placebo. No significant difference in the occurrence of adverse events (i.e., runny nose, cough, or temperature greater than or equal to38 degreesC) was noted during the 14 days after vaccination. There was no difference between groups in the occurrence of acute otitis media or serous otitis media. Paired serum samples were available for 109 of the seronegative vaccine recipients and for 110 of the seronegative placebo recipients; 84% of seronegative vaccine recipients developed a greater than or equal to4-fold increase in antibody titers. The geometric mean antibody titer after vaccination was 1: 25 in the vaccine group and