WHO：Guidelines on clinical evaluation of vaccines

scarlin

1. Introduction
These WHO Guidelines are intended to replace the WHO Guidelines on clinical evaluation of vaccines: regulatory expectations, which were adopted by the Expert Committee on Biological Standardization in 2001.

1. Introduction 506
2. Purpose and scope 508
3. Terminology 510
4. Vaccine clinical development programmes 514
    4.1 General considerations 514
    4.2 Pre-licensure clinical development programmes 516
    4.3 Post-licensure clinical evaluations 517
5. Immunogenicity 518
    5.1 General considerations 518
    5.2 Characterization of the immune response 518
    5.3 Measuring the immune response 519
    5.4 Identification and use of immune correlates of protection 524
    5.5 Immunogenicity trials 526
    5.6 Specific uses of immunogenicity trials 531
6. Efficacy and effectiveness 545
    6.1 General considerations for efficacy trials 545
    6.2 Types of efficacy trials 547
    6.3 Design and conduct of efficacy trials 548
    6.4 Approaches to determination of effectiveness 558
7. Safety 560
    7.1 General considerations 560
    7.2 Assessment of safety in clinical trials 560
    7.3 Size of the pre-licensure safety database 566
    7.4 Post-licensure safety surveillance 567
Authors and acknowledgements 569
References 571