drugset / Trial / NCT01111968

Evaluation of Pandemic Influenza A (H1N1)Candidate Vaccines

NCT01111968 ↗

RandomizedParallel-groupQuadruple-blindPrevention

Summary

This is a prospective phase I study to evaluate the safety, tolerability and immunogenicity of nine adjuvanted candidate vaccines against pandemic influenza A (H1N1) virus.

Timeline

Start
2010-01
Primary completion
2010-12
Completion
2011-03

Outcome

Met primary endpoint

paper Four 2009 influenza A (H1N1) inactivated monovalent candidate vaccines that met the three requirements to evaluate influenza protection, after a single dose, were identified: PMID 21945258 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject pandemic vaccine 1 Unknown 7.5 ug Intramuscular
Subject pandemic vaccine 10 Unknown 3.75 ug Intramuscular
Subject pandemic vaccine 2 Unknown 3.75 ug Intramuscular
Subject pandemic vaccine 5 Unknown 7.5 ug Intramuscular
Subject pandemic vaccine 6 Unknown 3.75 ug Intramuscular
Subject pandemic vaccine 9 Unknown 7.5 ug Intramuscular
Subject pandmeic vaccine 11 Unknown 7.5 ug Intramuscular
Subject pandmeic vaccine 12 Unknown 3.75 ug Intramuscular
Subject pandmic vaccine 13 Unknown 15 ug Intramuscular

Indications