NCT02256488

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

A Phase III, Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,561 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

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.

Conditions

• Prophylaxis: Influenza

Interventions

Type	Name	Description
BIOLOGICAL	TIVc_LOT A	Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
BIOLOGICAL	TIVc_LOT B	Single IM administration dose of 0.5 mL of TIVc
BIOLOGICAL	TIVc_LOT C	Single IM administration dose of 0.5 mL of TIVc
BIOLOGICAL	TIVf	Single IM administration dose of 0.5 mL of TIVf

Timeline

• Start date: 2014-09-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2014-10-03
• Last updated: 2019-06-11
• Results posted: 2015-08-07

Locations

24 sites across 1 country: United States