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

Abbott Biologicals622 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

622

Conditions

Influenza Vaccines

Interventions

Influenza VaccineBIOLOGICAL

surface antigen, inactivated, prepared in cell cultures

Influenza VaccineBIOLOGICAL

surface antigen, inactivated, prepared in egg (influvac ®)

Eligibility

Sex: ALLMin age: 61 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (12)

Site Reference ID/Investigator# 45005

Benátky nad Jizerou, Czechia

Site Reference ID/Investigator# 45004

Hradec Králové, Czechia

Site Reference ID/Investigator# 45007

Paide, Estonia

Outcomes

Primary Outcomes

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after vaccination, by applying the CHMP criteria for immunogenicity.

Time frame: 3 weeks

To assess the safety and tolerability of the cell-derived vaccine and compare to an egg-derived influenza vaccine.

Time frame: 6 months

To assess the safety and tolerability of the cell-derived vaccine following revaccination.

Time frame: 6 months

Secondary Outcomes

To assess the immunogenicity of the cell-derived subunit vaccine three weeks after revaccination, by applying the CHMP criteria for immunogenicity.

Time frame: 3 weeks

To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine.

Time frame: 6 months

Data from ClinicalTrials.gov

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