NCT01755364

A Trial to Assess the Immunogenicity and Safety of the Trivalent Virosomal Influenza Vaccine, Formulation of 2012-2013, in Healthy Subjects Aged Over 3 Years Old to 18 Years Old

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Adimmune Corporation · Industry
• Sex: All
• Age: 3 Years – 17 Years
• Healthy volunteers: Accepted

Summary

This is an open study of the use of AdimFlu-V (2012-2013 season) vaccine in young healthy subjects. Subjects aged equal to or over 9 years old and less than 18 years old will receive one dose of vaccine (0.5 mL) by intramuscular injection into the upper arm. Subjects aged equal to or over 3 years old and less than 9 years old will received two doses of vaccine (0.5 mL) by intramuscular injection into the upper arm separated by 4 weeks (28 days). Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events observed since first vaccination to 28 days after the last dose of vaccination, and serious adverse events during the observation. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each 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 subjects will be followed, either by clinical visit or by telephone contact, for 8 weeks after the last vaccination for safety reasons.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	AdimFlu-V

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-01-28
• Completion: 2013-03-01
• First posted: 2012-12-24
• Last updated: 2018-07-16

Locations

1 site across 1 country: Taiwan