Randomized controlled clinical trials of experimental vaccines

被引:0
作者
Naficy, AB [1 ]
Clemens, JD [1 ]
Rao, MR [1 ]
机构
[1] NICHHD, Epidemiol Branch, Bethesda, MD 20892 USA
来源
BULLETIN DE L INSTITUT PASTEUR | 1997年 / 95卷 / 04期
关键词
controlled clinical trial; random allocation; experimental vaccine; efficacy; effectiveness; methodology; public health; review;
D O I
10.1016/S0020-2452(97)83527-1
中图分类号
R392 [医学免疫学]; Q939.91 [免疫学];
学科分类号
100102 ;
摘要
Randomized controlled clinical trials to evaluate the clinical protection conferred by experimental vaccines and to provide further evidence of their safety are invariably demanded by regulatory agencies before these candidate vaccines can be licensed and introduced into routine public health practice. This review addresses the design of such trials.
引用
收藏
页码:187 / 196
页数:10
相关论文
共 33 条
  • [1] Armitage P., 1971, STAT METHODS MED RES
  • [2] BLACK RE, 1981, LANCET, V1, P141
  • [3] BROWN JA, 1966, BMJ-BRIT MED J, V5478, P7
  • [4] CHALMERS TC, 1983, CLIN TRIALS ISSUES A, P115
  • [5] Evaluating new vaccines for developing countries - Efficacy or effectiveness?
    Clemens, J
    Brenner, R
    Rao, M
    Tafari, N
    Lowe, C
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1996, 275 (05): : 390 - 397
  • [6] CLEMENS JD, 1986, LANCET, V2, P124
  • [7] THE BCG CONTROVERSY - A METHODOLOGICAL AND STATISTICAL REAPPRAISAL
    CLEMENS, JD
    CHUONG, JJH
    FEINSTEIN, AR
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1983, 249 (17): : 2362 - 2369
  • [8] CLEMENS JD, 1988, LANCET, V1, P1375
  • [10] ANALYSIS OF DATA ARISING FROM A STRATIFIED DESIGN WITH THE CLUSTER AS UNIT OF RANDOMIZATION
    DONNER, A
    DONALD, A
    [J]. STATISTICS IN MEDICINE, 1987, 6 (01) : 43 - 52