NCT02427750

A Study to Evaluate Safety and Immunogenicity of Trivalent Influenza Vaccine, Formulation 2015 Southern Hemisphere, When Administered to Healthy Adult Subjects.

A Phase II, Open-Label, Single-Arm, Multicenter Study to Evaluate the Safety and Immunogenicity of a Surface Antigen, Inactivated, Egg-Derived, Trivalent Influenza (Agrippal®) Virus Vaccine, Southern Hemisphere Formulation 2015, in Healthy Adults.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The present study is designed to evaluate the safety and immunogenicity of trivalent, surface antigen, inactivated influenza vaccine in 2 age cohorts: 18 to ≤60 years and ≥61 years. For the immunogenicity endpoint the antibody response to each influenza vaccine antigen will be evaluated by means of Single Radial Hemolysis (SRH) or Hemagglutination Inhibition (HI) at approximately 21 days post vaccination. The vaccine composition will be based on the WHO recommended influenza strains for the 2015 Southern Hemisphere vaccine, and the data from this study are intended to support the use of this vaccine in future influenza seasons if the recommended vaccine composition remains the same.

Conditions

• Human Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Aggripal®	TIV

Timeline

• Start date: 2015-04-01
• Primary completion: 2015-05-01
• Completion: 2015-05-01
• First posted: 2015-04-28
• Last updated: 2015-10-19
• Results posted: 2015-10-19

Locations

1 site across 1 country: Brazil