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

Phase 2

Completed

• Conditions: Influenza Vaccines
• Interventions: Biological: Influenza Vaccine

• Registration Number: NCT01013675
• Lead Sponsor: Abbott Biologicals

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-13
• Study First Submitted QC: 2009-11-13
• Study First Posted: 2009-11-16
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-10
• Last Update Submitted: 2011-10-26
• Last Update Posted: 2011-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 622

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Influenza Vaccine	15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose
2	Influenza Vaccine	15 mcg hemagglutinin (HA) per viral strain; 0.5 mL single dose

Primary Outcome Measures

Name	Time	Method
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.	3 weeks
To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.	6 months
To assess the safety and tolerability of the cell-derived vaccine following revaccination.	6 months

Secondary Outcome Measures

Name	Time	Method
To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.	3 weeks
To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.	6 months

Trial Locations

Locations (12)

Site Reference ID/Investigator# 45010; 🇪🇪 Tallinn, Estonia

Site Reference ID/Investigator# 45005; 🇨🇿 Benatky nad Jizerou, Czech Republic

Site Reference ID/Investigator# 45004; 🇨🇿 Hradec Kralove, Czech Republic

Site Reference ID/Investigator# 45007; 🇪🇪 Paide, Estonia

Site Reference ID/Investigator# 45013; 🇪🇪 Tartu, Estonia

Site Reference ID/Investigator# 45016; 🇱🇹 Kaunas, Lithuania

Site Reference ID/Investigator# 45018; 🇱🇹 Kaunas, Lithuania

Site Reference ID/Investigator# 45012; 🇪🇪 Saku, Estonia

Site Reference ID/Investigator# 45009; 🇪🇪 Tallinn, Estonia

Site Reference ID/Investigator# 45019; 🇱🇹 Klaipeda, Lithuania

Site Reference ID/Investigator# 45017; 🇱🇹 Kaunas, Lithuania

Site Reference ID/Investigator# 45015; 🇱🇹 Kaunas, Lithuania