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        <div id="content-top1">Page 1 - EMA e Vaccini: Linee Guida</div>
        <div id="content-top2">P. 1</div>
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    <pre style="white-space:pre-line"><code>1 26 April 2018                                                                                                   March 2017
2 EMEA/CHMP/VWP/164653/05 Rev. 1
3 Committee on Human Medicinal Products (CHMP)

4

5 Guideline on clinical evaluation of vaccines

6

7 Draft

8

9

       Draft Rev. 1 agreed by Vaccine Working Party (VWP)

    Adopted by CHMP for release for consultation                                     26 April 2018

    Start of public consultation                                                     30 April 2018

    End of consultation (deadline for comments)                                    30 October 2018

10

11 This guideline replaces â€˜Guideline on the clinical evaluation of new vaccinesâ€™

12 (EMEA/CHMP/VWP/164653/05) including its â€˜Annex on SPC requirementsâ€™

13 (EMEA/CHMP/VWP/382702/06) and â€˜Guideline on adjuvants in vaccines for human useâ€™

14 (EMEA/CHMP/VEG/134716/04)

15

16

    Comments should be provided using this template. The completed comments form should be sent to

    VWP@ema.europa.eu

17

    Keywords           Vaccine, humoral immune response, cellular immune response,

                       vaccination schedule, immunogenicity studies, protective efficacy,

                       effectiveness, safety, immune correlates of protection

18

    30 Churchill Placeâ— Canary Wharf â— London E14 5EUâ— United Kingdom   An agency of the European Union
    Telephone +44 (0)20 36606000 Facsimile +44 (0)20 3660 5555
    Send a question via our website www.ema.europa.eu/contact

              Â© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.</code></pre>
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