NCT03893669

Safety, Tolerability and Immunogenicity of an Trivalent Inactivated Cell-Culture Influenza Vaccine in Healthy Adults

Randomized, Double-blinded, Controlled, Phase I Trial to Assess Safety, Tolerability and Immunogenicity of 'NBP607(Trivalent Inactivated Cell-Culture Influenza Vaccine)' Compared to Egg-based Influenza Vaccine in Healthy Adult

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: SK Chemicals Co., Ltd. · Industry
• Sex: All
• Age: 20 Years – 59 Years
• Healthy volunteers: Accepted

Summary

A randomized, double-blinded, controlled, Phase I clinical trial to assess the safety, tolerability and immunogenicity of 'NBP607(trivalent inactivated cell-culture influenza vaccine)' compared to egg-based influenza vaccine in healthy adult volunteers

Detailed description

1. Assessment of Safety 2. Assessment of Immunogenicity 3. Estimated Enrollment: 100

Conditions

• Prevention of Influenza

Interventions

Type	Name	Description
BIOLOGICAL	NBP607	1 dose, 0.5ml, Intramuscular (IM) injection
BIOLOGICAL	Agrippal	1 dose, 0.5ml, Intramuscular (IM) injection

Timeline

• Start date: 2012-09-01
• Primary completion: 2012-10-01
• Completion: 2012-11-01
• First posted: 2019-03-28
• Last updated: 2019-03-28

Locations

1 site across 1 country: South Korea