drugset / Trial / NCT05667740

Safety, Tolerability and Immunogenicity of an Inactivated Whole-cell Pneumococcal Vaccine Gamma-PN3.

NCT05667740

Phase 1 Completed 118 enrolled GPN Vaccines
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a randomised placebo-controlled first-in-man dose-ranging study to determine safety and markers of efficacy.

Timeline

Start
2023-01-16
Primary completion
2023-10-08
Completion
2023-10-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Gamma-PN3 Vaccine 50 ug
Subject Gamma-PN3 Vaccine 250 ug
Subject Gamma-PN3 Vaccine 1000 ug
Comparator Pneumovax 23 Vaccine
Comparator Prevnar 13 Vaccine