应当对任何观测到的差别评价其临床相关性，对每一个组分在免疫剂量或免疫程

Any observed difference should be evaluated for its clinical relevance, and for each component's change in immunization dose or immunization program, there should be clinical data as the basis for its change. <br><br>The number of product batches used for clinical verification can be less than the number of batches used for production consistency studies. <br><br>However, in some cases, for example, when the product contains components that have not obtained a production number, more batches should be used in clinical verification, and at least one batch of products should be used for production consistency studies. The same batch of monovalent vaccine prepared for the combined vaccine was used for a control group test to avoid differences in immunogenicity due to differences between batches. <br><br>The differences between the vaccine batches used should be analyzed. <br>Therefore, clinical trials should also consider the impact of the above factors on clinical research results.

The clinical relevance of any observed differences should be evaluated, and clinical data should be used as the basis for each change in the dose or immune procedure of each group.<br><br>The batch number of products used for clinical validation can be smaller than the number of batches used for production consistency studies.<br><br>However, in some cases, for example, when a product contains a composition that has not been produced, more batches should be used for clinical validation, at least one batch should be used for the production of conformity studies, and control group trials of the same batch of unit-price vaccines prepared for joint vaccines should be used to avoid differences in immunogenicity due to differences in batches.<br><br>The differences between the batch of vaccines used are analyzed.<br>Therefore, clinical trials should also consider the impact of these factors on clinical results.

The clinical relevance of any observed difference should be evaluated, and clinical data should be used as the basis for the change of each component in the immune dose or immune program.<br>The number of batches of products used for clinical validation can be less than that for production conformity studies.<br>However, in some cases, for example, when the product contains components without production number, more batches should be used in clinical verification, and at least one batch should be used for production consistency study. In addition, the same batch of monovalent vaccine prepared by the combined vaccine should be used for the control group test of vaccination, so as to avoid the difference of immunogenicity due to the difference between batches.<br>The differences between batches of vaccines used should be analyzed.<br>Therefore, clinical trials should also consider the above factors on the impact of clinical research results.<br>