drugset / Trial / NCT01342796

Humoral and Cell Mediated Immunity and Safety of MF59C.1-adjuvanted Subunit Influenza Vaccine or a Conventional Subunit Influenza Vaccine in Previously Unvaccinated Healthy Subjects

NCT01342796 ↗

Phase 2 Completed 84 enrolled Novartis Vaccines
RandomizedParallel-groupSingle-blindPrevention

Summary

This study aims to evaluate the immunogenicity, by means of cell mediated immunity (CMI) and hemagglutination inhibition (HI) assay, and also the safety of a MF59C.1-adjuvanted subunit influenza vaccine compared with a conventional subunit vaccine in previously unvaccinated children aged 6 to \<36 months.

Timeline

Start
2011-05
Primary completion
2012-02
Completion
2012-02

Drugs

EvaluationDrugModalityDoseRoute
Subject MF59C.1-adjuvanted subunit influenza vaccine Vaccine 0.25 ml Intramuscular
Comparator Sub unit, Inactivated, Influenza vaccine Vaccine 0.25 ml Intramuscular

Indications