Study Measuring the Safety, Immunogenicity and Lot Consistency of Cell Derived Influenza Vaccine

Phase 3

Completed

• Conditions: Influenza
• Interventions: Biological: Influenza Vaccine

• Registration Number: NCT00999206
• Lead Sponsor: Abbott Biologicals

Brief Summary

A phase 3 study to obtain additional safety and immunogenicity data on Solvay's cell-derived seasonal trivalent subunit influenza vaccine in adult and elderly subjects without significant illnesses and to demonstrate consistency of the immunogenicity of the three lots of the same vaccine, comparison of cell-derived vaccine to Solvay's egg-derived vaccine including assessment of non-inferior immunogenicity

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-20
• Study First Submitted QC: 2009-10-20
• Study First Posted: 2009-10-21
• Study Start: 2010-01
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-25
• Last Update Posted: 2011-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Influenza Vaccine	-
2	Influenza Vaccine	-
3	Influenza Vaccine	-
4	Influenza Vaccine	-

Primary Outcome Measures

Name	Time	Method
Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase	3 weeks

Trial Locations

Locations (19)

Site Reference ID/Investigator# 44663; 🇦🇺 Hornsby, Australia

Site Reference ID/Investigator# 44649; 🇦🇺 Caboolture, Australia

Site Reference ID/Investigator# 44656; 🇳🇿 Grafton, New Zealand

Site Reference ID/Investigator# 44652; 🇦🇺 Adelaide, Australia

Site Reference ID/Investigator# 44650; 🇦🇺 Herston, Australia

Site Reference ID/Investigator# 44653; 🇳🇿 Christchurch, New Zealand

Site Reference ID/Investigator# 44646; 🇦🇺 Carina Heights, Australia

Site Reference ID/Investigator# 44645; 🇦🇺 Kippa-Ring, Australia

Site Reference ID/Investigator# 44657; 🇳🇿 Wellington, New Zealand

Site Reference ID/Investigator# 44644; 🇦🇺 Malvern East, Australia

Site Reference ID/Investigator# 44655; 🇳🇿 Rotorua, New Zealand

Site Reference ID/Investigator# 44662; 🇦🇺 Auchenflower, Australia

Site Reference ID/Investigator# 44648; 🇦🇺 Maroubra Junction, Australia

Site Reference ID/Investigator# 44643; 🇦🇺 Sherwood, Australia

Site Reference ID/Investigator# 44651; 🇦🇺 Blacktown, Australia

Site Reference ID/Investigator# 44659; 🇦🇺 Blacktown, Australia

Site Reference ID/Investigator# 44647; 🇦🇺 Broadmeadow, Australia

Site Reference ID/Investigator# 44658; 🇳🇿 Dunedin, New Zealand

Site Reference ID/Investigator# 44654; 🇳🇿 Tauranga, New Zealand