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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01013675

Enrollment

622

Registered

2009-11-16

Start date

2009-11-30

Completion date

2011-04-30

Last updated

2011-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza Vaccines

Keywords

influenza, active-controlled, Phase 2

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.

Interventions

BIOLOGICALInfluenza Vaccine

surface antigen, inactivated, prepared in cell cultures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

61 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Czechia, Estonia, Lithuania

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026