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

Influenza Clinical Trial

Official title:

Randomized, Double-Blind Study to Assess Safety, Immunogenicity, and Lot Consistency of Solvay's Cell-Derived Influenza Vaccine and Its Non-Inferiority Compared to Influvac®.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00999206
• Other study ID #: S203.3.013
• Status: Completed
• Phase: Phase 3
• First received: October 20, 2009
• Last updated: August 25, 2011
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: National Health and Medical Research CouncilNew Zealand: Medsafe
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3138
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

1. Female or male subjects >= 18 years of age (adults >= 18 to < =60 years of age or elderly >= 61 years of age).

2. Willing and able to give informed consent before any protocol procedures are performed.

3. Able to adhere to visit schedules and all protocol required study procedures.

4. Being in good health as determined by medical history, physical examination and clinical judgment of the investigator (subjects may have underlying illnesses such as hypertension, diabetes, ischemic heart disease or hypothyroidism, as long as the disease is well controlled. If on medication for a condition, the medication dose must have been stable for at least 3 months preceding study vaccination).

Exclusion Criteria

1. Influenza vaccination or laboratory confirmed influenza infection within six months preceding the date of study vaccination or planning an influenza vaccination during the three weeks after study vaccination (i.e. between study Day 1 and study Day 22).

2. Presence of any significant condition that may prohibit inclusion as determined by the Investigator.

3. A serious adverse reaction after a previous (influenza) vaccination.

4. A history of Guillain-Barré syndrome.

5. Known to be allergic to constituents of the study vaccines.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
• Influenza Vaccine
surface antigen, inactivated, prepared in egg (influvac ®)
• Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures
• Influenza Vaccine
surface antigen, inactivated, prepared in cell cultures

Locations

Country	Name	City	State
Australia	Site Reference ID/Investigator# 44652	Adelaide
Australia	Site Reference ID/Investigator# 44662	Auchenflower
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# 44649	Caboolture
Australia	Site Reference ID/Investigator# 44646	Carina Heights
Australia	Site Reference ID/Investigator# 44650	Herston
Australia	Site Reference ID/Investigator# 44663	Hornsby
Australia	Site Reference ID/Investigator# 44645	Kippa-Ring
Australia	Site Reference ID/Investigator# 44644	Malvern East
Australia	Site Reference ID/Investigator# 44648	Maroubra Junction
Australia	Site Reference ID/Investigator# 44643	Sherwood
New Zealand	Site Reference ID/Investigator# 44653	Christchurch
New Zealand	Site Reference ID/Investigator# 44658	Dunedin
New Zealand	Site Reference ID/Investigator# 44656	Grafton
New Zealand	Site Reference ID/Investigator# 44655	Rotorua
New Zealand	Site Reference ID/Investigator# 44654	Tauranga
New Zealand	Site Reference ID/Investigator# 44657	Wellington

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Biologicals	Quintiles, Inc.

Countries where clinical trial is conducted

Australia,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-HA antibody titers and derived parameters seroprotection, seroconversion and fold increase		3 weeks	No