Module 9 2024

03/09/2024

Vaccine Clinical Development Process

Early Phase

Phase IIIb/IV Licensure N=millions

Phase I N=20 – 80

Phase II N=>100s

Phase III N=1000s – 10,000s

Safety

Safety

Safety

Safety

Immunogencity

Immunogencity

Immunogencity

Proof of concept

Efficacy

Effectiveness

Dose ranging

New indications

Safety Evaluation – Loca l

Pharmacovigilance

– Systemic

– AE

– SAE

All vaccine clinical studies have safety objectives, often as co-primary

The Organisation for Professionals in Regulatory Affairs

Leroux-Roels et al. Chapter 5 in: Garçon et al. Understanding Modern Vaccines, Perspectives in Vaccinology, Vol 1, Amsterdam, Elsevier, 2011

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Vaccine Clinical Development Process

Early Phase

Phase IIIb/IV Licensure N=millions

Phase I N=20 – 80

Phase II N=>100s

Phase III N=1000s – 10,000s

Safety

Safety

Safety

Safety

Immunogencity Phase I : First administration in man ~ 20 subjects; usually adults

Immunogencity

Immunogencity

Evaluate safety of the vaccine Might evaluate tolerability of increasing doses of vaccine (dose escalation) Determine safety of two or more successive vaccinations Evaluate immune response

Proof of concept

Efficacy

Effectiveness

Dose ranging

New indications

Safety Evaluation – Loca l

Pharmacovigilance

– Systemic

– AE

– SAE

All vaccine clinical studies have safety objectives, often as co-primary

The Organisation for Professionals in Regulatory Affairs

Leroux-Roels et al. Chapter 5 in: Garçon et al. Understanding Modern Vaccines, Perspectives in Vaccinology, Vol 1, Amsterdam, Elsevier, 2011

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