NCT02344134

Study of Egg-derived Influenza Vaccine and Cell Culture-derived Influenza Vaccine in Adult and Elderly Subjects

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of NBP607 (Trivalent Inactivated Cell Culture-derived Influenza Vaccine) in Healthy Adults and Elderly Subjects

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,155 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to describe the immunogenicity and safety of the cell culture-derived influenza vaccine compared with the egg-derived influenza vaccine among subjects. To describe the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained pre-vaccination and 21 days post-vaccination. To describe the safety, the time of onset and duration of local and systemic solicited adverse events are assessed and reported. Unsolicited adverse events and serious adverse events are collected and categorized throughout the study period.

Detailed description

This is a multi-center, randomized, double-blind study in healthy adult and elderly subjects. Subjects receive a single dose of one of the influenza vaccine formulations and provide blood samples for immunogenicity assessment.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
BIOLOGICAL	NBP607	0.5 mL, intramuscular, a single dose
BIOLOGICAL	Agrippal S1	0.5 mL, intramuscular, a single dose

Timeline

• Start date: 2013-09-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2015-01-22
• Last updated: 2015-01-22