Challenging Children’s Vaccine Trial Conducted Successfully

Case Study

PPD provided various services for a randomized, double-blind trial to assess the safety and relative efficacy of a study vaccine against another influenza vaccine in children 6 to 59 months of age. The Phase III study involved 303 sites in Belgium, Czech Republic, Finland, Germany, Greece, Iceland, Israel, Italy, Lebanon, Poland, Spain, Sweden, Switzerland, United Kingdom and United States. The protocol required a six-month follow-up for each patient along with weekly monitoring, which PPD accomplished using a third-party interactive voice response (IVR) diary system.

For the study, PPD provided clinical monitoring, clinical project management, data management, IVR, pharmacovigilance and regulatory affairs services. The task was to enlist 7,900 patients in 10 days. Also, all sites had to start on the same day and time across all countries, and that posed the following challenges:

• Ensuring all ethics committee or regulatory approvals were obtained on time
• Guaranteeing availability of drugs and other clinical supplies
• Ensuring quality data with a large number of patients

PPD obtained all the approvals on time and based the vaccine supply on advanced enrollment projections to ensure there was enough vaccine at each site for enrollment. To ensure the quality of data, PPD:

• Limited patient enrollment to a predetermined number per site
• Required fully dedicated study coordinators
• Maintained daily contact with the sites during enrollment
• Performed the first interim monitoring visit on the first day or within three days of enrollment