drugset / Trial / NCT01465035

A Study to Determine the Safety and Immunogenicity of Co-administration of the Candidate Influenza Vaccine MVA-NP+M1 and Seasonal Influenza Vaccine

NCT01465035 ↗

Phase 1 Completed 24 enrolled University of Oxford
RandomizedParallel-groupSingle-blindPrevention

Summary

This is a single blinded placebo controlled phase I study, to assess the safety and immunogenicity of co-administration of the candidate influenza vaccine MVA-NP+M1 with seasonal influenza vaccine. All volunteers recruited will be adults aged 50 and over. The rationale behind co-administration of MVA-NP+M1 with a seasonal influenza vaccine (TIV) is that the immune system will be stimulated to produce both influenza specific T cells and influenza specific antibodies.

Timeline

Start
2011-10
Primary completion
2012-11
Completion
2012-11

Drugs

EvaluationDrugModalityDoseRoute
Subject MVA-NP+M1 Vaccine 1.5e+08 unknown Intramuscular
Comparator Inactivated Influenza Vaccine (Split Virion) Vaccine 15 ug Intramuscular
Comparator Inactivated Influenza Vaccine (Split Virion) Vaccine 0.5 ml Intramuscular

Indications