Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly

Influenza Vaccines Clinical Trial

Official title:

Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01013675
• Other study ID #: S203.2.009
• Secondary ID: 2009-014767-40
• Status: Completed
• Phase: Phase 2
• First received: November 13, 2009
• Last updated: October 26, 2011
• Start date: November 2009
• Est. completion date: April 2011

Study information

• Verified date: October 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of Health
• Study type: Interventional

Clinical Trial Summary

A controlled, double-blind study to determine the immunogenicity and safety of influenza cell derived vaccine in elderly subjects.

Description:

This current phase II study is to pursue objectives similar to those of the ongoing adult phase II trial, but to expand into the elderly population who are more than 60 years of age. The results of this randomized, double blind, egg derived influenza vaccine (Influvac) - controlled, parallel-trial, in healthy elderly subjects are to be conducted over two consecutive years in multiple centers in Europe. At study initiation 600 subjects will be randomly allocated to receive the cell-derived or egg-derived influenza vaccine. At start of the second year subjects will be randomly re-allocated following stratification based upon the initial drug they were allocated and had received.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 622
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 61 Years and older

Eligibility

Inclusion Criteria

1. Willing and able to give informed consent and able to adhere to all protocol required study procedures.

2. Men and women (elderly)

3. Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria

1. Known to be allergic to constituents of the vaccine.

2. A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.

3. Having received vaccination against influenza or lab confirmed influenza within the previous six months before study vaccination.

Study Design

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

Related Conditions & MeSH terms

• Influenza Vaccines
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Czech Republic	Site Reference ID/Investigator# 45005	Benatky nad Jizerou
Czech Republic	Site Reference ID/Investigator# 45004	Hradec Kralove
Estonia	Site Reference ID/Investigator# 45007	Paide
Estonia	Site Reference ID/Investigator# 45012	Saku
Estonia	Site Reference ID/Investigator# 45009	Tallinn
Estonia	Site Reference ID/Investigator# 45010	Tallinn
Estonia	Site Reference ID/Investigator# 45013	Tartu
Lithuania	Site Reference ID/Investigator# 45015	Kaunas
Lithuania	Site Reference ID/Investigator# 45016	Kaunas
Lithuania	Site Reference ID/Investigator# 45017	Kaunas
Lithuania	Site Reference ID/Investigator# 45018	Kaunas
Lithuania	Site Reference ID/Investigator# 45019	Klaipeda

Sponsors (2)

Lead Sponsor	Collaborator
Abbott Biologicals	Quintiles, Inc.

Countries where clinical trial is conducted

Czech Republic,  Estonia,  Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.		3 weeks	No
Primary	To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.		6 months	Yes
Primary	To assess the safety and tolerability of the cell-derived vaccine following revaccination.		6 months	Yes
Secondary	To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.		3 weeks	No
Secondary	To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.		6 months	No