NCT01320696

Reverse Genetic H9N2 Influenza Vaccine Study in Adults

A Randomized, Double Blind, Multi-center, Phase 1/2 Study to Assess Safety and Immunogenicity of Five Dose Levels of a Reverse Genetic (RG) Reassortant H9N2 Pandemic Influenza Vaccine in Healthy Subjects Aged 18 to 49 Years

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Alachua Government Services, Inc. · Industry
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to identify the optimal dose level of a reverse genetic (RG) reassortant H9N2 pandemic influenza vaccine for further product development.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine	Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation

Timeline

• Start date: 2011-03-01
• Primary completion: 2011-06-01
• Completion: 2012-05-01
• First posted: 2011-03-22
• Last updated: 2023-02-16
• Results posted: 2023-02-16

Locations

5 sites across 1 country: United States