Serum Institute of India Pvt. Ltd. (SIIPL), in collaboration with WHO-PATH, initiated a global vaccine development program targeting meningococcal disease in sub-Saharan Africa’s “meningitis belt.” The initiative required:
DiagnoSearch provided comprehensive services across multiple geographies and trial phases:
Clinical & Operational Services
Full-service Data Management and Biostatistics
Pharmacovigilance support across all trial phases
Central Laboratory Services across all sites
Project Management and Clinical Monitoring for India-based studies
DiagnoSearch played a strategic role in assay standardization and quality assurance for global immunoanalytical laboratories:
Appointed Quality Assurance Partner for the Meningitis Vaccine Laboratory (CDC) for a two-year tenure
The clinical program enrolled approximately 15,400 subjects across both India and sub-Saharan Africa. This included around 14,200 participants in 8 projects across Africa (Phases II–IV) and 1,252 subjects across 3 India-based studies (Phases I and III). Over 325,000 CRF pages were processed with rigorous quality control and data integrity standards
DiagnoSearch’s global coordination, scientific leadership, and operational excellence were central to the success of this multi-country collaboration. The project directly contributed to the successful development and introduction of a life-saving meningococcal vaccine, protecting millions across Africa’s meningitis belt.
Meningitis Vaccine Program in India & sub-Saharan Africa
DiagnoSearch supported SIIPL and WHO-PATH across the full clinical development lifecycle of a meningococcal vaccine, providing full-spectrum services and global lab standardization. The program helped enable the vaccine’s successful introduction across Africa.
