Module 9 2024

03/09/2024

Specific Considerations for Vaccines

Clinical Efficacy

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New Vaccine : Efficacy

But…efficacy studies are not always possible

• Need to conduct randomised controlled studies

• Studies using placebo or negative controls may be unethical if there is a vaccine that protects against same disease that is recommended in that target population • Issue when developing second generation vaccines and/or new vaccine combinations (DTaP-HBV-IPV-Hib-MenC ; MMRV…)

The Organisation for Professionals in Regulatory Affairs

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