NCT01759654

A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Non-Elderly Adults and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in non-elderly and elderly subjects. All participates will receive one dose of vaccine (0.5 ml) by intramuscular injection into the upper arm. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions for 7 days, unsolicited adverse events for 28 days, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 28 days after vaccination. Anti-hemagglutinin (HA) antibody titers will be determined using the WHO hemagglutination inhibition reference technique. The central laboratory who is responsible for antibody titrations will not be aware of the background of blood samples (e.g., pre- or post-serum), it is also called observer-blinded. All participates will be followed, either by clinical visit or by telephone contact, for 8 weeks after the vaccination for safety reasons.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AdimFlu-V

Timeline

• Start date: 2012-10-24
• Primary completion: 2012-12-25
• Completion: 2013-03-01
• First posted: 2013-01-03
• Last updated: 2018-07-16

Locations

1 site across 1 country: Taiwan