A phase I/II randomized, double-blind, positive-controlled dose-exploration study to evaluate the safety and immunogenicity of a virus-like particle (VLP) based polio vaccine VLP-Polio against Poliomyelitis in infants from 6 weeks of age and toddlers 12-18 months of age.
Outcome
To determine the incidence, source of, and risk factors for, neonatal colonisation with MDR gram negative pathogens; and to assess the impact of colonisation with MDR gram-negative pathogens on neonatal morbidity and mortality in Indonesia
Sponsor
CanSino Biologics
Date
- Present
Subjects
Phase I: 96 subjects, Phase II: 384 subjects