Clinical Trial: Study of a Novel Type 1 Oral Poliomyelitis Vaccine in Bangladesh
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Poliomyelitis
Study Type: INTERVENTIONAL
Official Title: A Phase 2, Randomized, Observer-blind, Controlled, Age De-escalation, Dosage Escalation Study to Assess Safety and Immunogenicity of a Novel Live Attenuated Type 1 Oral Poliomyelitis Vaccine in Health
Brief Summary:
The purpose of this clinical trial is to assess the safety and tolerability (primary objective), immunogenicity (primary and secondary objectives), fecal shedding of vaccine viruses (secondary objective) and the potential for neurovirulence of shed virus (secondary objective) of a novel oral polio type 1 vaccine, nOPV1, as compared to Sabin monovalent type 1 vaccine controls (mOPV1), in healthy young children (192 subjects), infants (720 subjects), and neonates (1320 subjects).
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