NCT01752881

Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2012-2013, in Non-Elderly Adult and Elderly Subjects

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 130 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the licensed seasonal flu vaccine, as measured by hemagglutination inhibition (HAI) at three weeks post immunization in non-elderly and elderly subjects in compliance with the requirements of the current European Union (EU) recommendations for the evaluation of the immunogenicity for a new formulation of a licensed flu vaccine (CPMP/BWP/214/96).

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Influenza vaccine (split virion, inactivated)	AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013 Dosage: 0.5mL/per syringe Administration route: Intramuscular Injection, once
BIOLOGICAL	AdimFlu-S

Timeline

• Start date: 2012-08-01
• Primary completion: 2012-08-01
• Completion: 2012-09-01
• First posted: 2012-12-19
• Last updated: 2012-12-19

Locations

1 site across 1 country: Taiwan