Vaccine clinical trials aim to establish the safety and efficacy of a vaccine prior to it being licensed. They offer protection to both the users and the manufacturers.
Want to know more?
Here are two presentations from the World Vaccine Congress Washington 2012!
Novel strategies for improving early-stage vaccine clinical studies by Dr Doug Girgenti, Global Clinical Program Lead, Pfizer.
â€¢ Concept of true "Phase 0" or "microdose" studies
â€¢ Utility of supportive studies of novel early phase vaccine programs
â€¢ Early -phase considerations for patient population-based vaccine programs
Monitoring Safety in Vaccine Clinical Trials by Ann Wouters, Assistant Director, Clinical Scientist, Pfizer.
1. Characteristics and design of vaccine study
a. Adverse Event categories and reporting time lines
b. Solicited Local and systemic reactogenicity
c. Solicited laboratory parameters
2. Unsolicited adverse event- events
3. Safety Data Review Process
4. Role of Data Monitoring Committees