NCT03826719

Safety, Tolerability and Immunogenicity of NBP607QIV in Healthy Adult Volunteers

A Randomized, Double-blinded, Controlled, Phase I/II Clinical Trial to Assess the Safety, Tolerability and Immunogenicity of NBP607QIV Compared to Trivalent Egg-based Influenza Vaccine in Healty Adult Volunteers

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 19 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This study assesses safety, tolerability and immunogenicity of NBP607QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease.

Detailed description

Subjects are randomly assigned in a 1:1 ratio to NBP607QIV versus Agrippal S1. To assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited adverse events for 28 days post-vaccination are assessed and reported. To assess the immunogenicity, antibody levels are evaluated by hemagglutination inhibition(HI) assay from sera obtained at pre-vaccination and 21 days post-vaccination.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	NBP607QIV	Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
BIOLOGICAL	Agrippal	Influenza virus surface antigens of three strains(trivalent)

Timeline

• Start date: 2014-02-17
• Primary completion: 2014-03-28
• Completion: 2014-03-28
• First posted: 2019-02-01
• Last updated: 2019-02-01