Recruitment Strategy for Pediatric Vaccine Mega-Trial

This case study outlines the implementation of a novel approach for recruiting participants in a seasonal pediatric vaccine mega-trial. The Fortrea team employed a family-focused and site-centric study design, enhancing the experience for parents, family members, and researchers. Key strategies included minimizing participant burden, incorporating digital health innovations, and developing a flexible resourcing model. The study achieved its first participant milestone nearly eight weeks ahead of schedule. The design required only one scheduled physical visit and no blood draws, aligning with standard care practices. Proactive outreach to key opinion leaders and healthcare providers was initiated to generate awareness and interest, addressing low initial participation due to site fatigue from the COVID-19 pandemic. The study successfully recruited over 8,000 infants across 210 sites in three countries, meeting its primary endpoint of hospitalization due to lower respiratory tract infections within 11 months of protocol approval. The case study emphasizes the importance of careful planning and stakeholder engagement in executing large clinical trials.