drugset / Trial / NCT02255279

Safety and Immunogenicity of an Adjuvanted Trivalent Influenza Vaccine in Children 6 to <72 Months of Age in Mexico.

NCT02255279

Phase 3 Completed 287 enrolled Novartis Vaccines
RandomizedParallel-groupTriple-blindPrevention

Summary

The administration of adjuvanted Trivalent Influenza Vaccine (aTIV) has come to result in a more immunogenic and effective response compared with conventional influenza vaccines in elderly and adults. The aim of this study is to evaluate safety and immunogenicity of Novartis aTIV in children 6 to \<72 months of age, Mexican population, in comparison to Fluzone, a non-adjuvanted trivalent influenza vaccine (TIV).

Timeline

Start
2014-10
Primary completion
2015-05
Completion
2015-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluad Vaccine 0.25 ml
Subject Fluad Vaccine 0.5 ml
Comparator Influenza Virus Vaccine Vaccine 0.25 ml
Comparator Influenza Virus Vaccine Vaccine 0.5 ml

Indications