drugset / Trial / NCT02256488

Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

NCT02256488 ↗

Phase 3 Completed 1561 enrolled Novartis Vaccines
RandomizedParallel-groupDouble-blindOther

Summary

The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf). The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study. The total study participation time per subject is about 3 weeks.

Timeline

Start
2014-09
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject TIVc Vaccine 0.5 ml Intramuscular
Comparator TIVf Vaccine 0.5 ml Intramuscular

Indications

No indication recorded.