Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination

Phase 2

Completed

• Conditions: Influenza
• Interventions: Biological: Cell-Derived Trivalent Subunit Influenza Vaccine; Biological: Placebo

• Registration Number: NCT00889889
• Lead Sponsor: Abbott Biologicals

Brief Summary

Immunogenicity and safety of a cell-derived influenza vaccine in adults aged \>= 18 and \<= 64 years, plus revaccination

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-28
• Study First Submitted QC: 2009-04-28
• Study First Posted: 2009-04-29
• Study Start: 2009-05
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Disposition First Submitted: 2012-01-24
• Disposition First Submitted QC: 2012-01-24
• Disposition First Posted: 2012-01-30
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-27
• Last Update Posted: 2013-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1270

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cell-Derived Trivalent Subunit Influenza Vaccine	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
To assess after the first vaccination the safety and tolerability of the cell-derived subunit vaccine compared to placebo.	6 months
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the FDA requirement for influenza vaccines.	3 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination.	3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.	6 months
To assess after the second vaccination the safety and tolerability of the cell-derived subunit vaccine.	6 months

Trial Locations

Locations (15)

Site Reference ID/Investigator# 45696; 🇺🇸 Nashville, Tennessee, United States

Site Reference ID/Investigator# 45691; 🇺🇸 Lenexa, Kansas, United States

Site Reference ID/Investigator# 45694; 🇺🇸 Wichita, Kansas, United States

Site Reference ID/Investigator# 45690; 🇺🇸 Jacksonville, Florida, United States

Site Reference ID/Investigator# 45687; 🇺🇸 Pembroke Pines, Florida, United States

Site Reference ID/Investigator# 45697; 🇺🇸 South Miami, Florida, United States

Site Reference ID/Investigator# 45689; 🇺🇸 Overland Park, Kansas, United States

Site Reference ID/Investigator# 45682; 🇺🇸 Lexington, Kentucky, United States

Site Reference ID/Investigator# 45684; 🇺🇸 Kansas City, Missouri, United States

Site Reference ID/Investigator# 45685; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 45686; 🇺🇸 Las Vegas, Nevada, United States

Site Reference ID/Investigator# 45688; 🇺🇸 Raleigh, North Carolina, United States

Site Reference ID/Investigator# 45683; 🇺🇸 Austin, Texas, United States

Site Reference ID/Investigator# 45692; 🇺🇸 Salt Lake City, Utah, United States

Site Reference ID/Investigator# 45695; 🇺🇸 Fort Worth, Texas, United States