At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A First-in-human, Phase 1, Randomized, Observer-blind, Controlled Study to Assess the Safety and Immunogenicity of Novel Live Attenuated Type 1 and Type 3 Oral Poliomyelitis Vaccines in Healthy Adults
In Brief
A Phase 1 clinical trial evaluating Novel Oral Polio Vaccine Type 1 (nOPV1), Novel Oral Polio Vaccine Type 3 (nOPV3), and 2 other interventions for Poliomyelitis. Completed, enrolled 226 participants across 4 sites.
Detailed Summary
The purpose of this study is to assess the safety (primary objective), the ability to trigger the production of antibodies (immunogenicity; a secondary objective) and presence of vaccine virus in the stool (fecal shedding; a secondary objective) of two novel oral polio vaccines (nOPV), novel oral poliomyelitis vaccine type 1 (nOPV1) and novel oral poliomyelitis vaccine type 3 (nOPV3), as compared to Sabin strain monovalent oral poliomyelitis vaccine (mOPV) controls, in healthy adults.
Study Details
Timeline
Interventions
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10\^6.5 CCID50.
Each 0.1 mL (2 drops) dose of vaccine contains approximately 10\^6.5 CCID50.
The Sabin mOPV1 control vaccine contains ≥ 10\^6.0 CCID50 per 0.1 mL (2 drops) dose.
the Sabin mOPV3 control vaccine contains ≥ 10\^5.8 CCID50 per 0.1 mL (2 drops) dose.