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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01013675
• Date of registration: 13/11/2009
• Prospective Registration: No
• Primary sponsor: Abbott Biologicals
• Public title: Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Elderly
• Scientific title: Randomized, Double-blind, Active -Controlled Trial to Assess Safety and Immunogenicity of Solvay's Cell-derived Influenza Vaccine, Including Revaccination, in Elderly Subjects
• Date of first enrolment: November 2009
• Target sample size: 622
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01013675
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
• Phase: Phase 2

Countries of recruitment

Czech Republic, Estonia, Lithuania

Contacts

• Name: Hanka de Voogd, MD
• Affiliation: Abbott Healthcare Products B.V

Key inclusion & exclusion criteria

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.



Age minimum: 61 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Influenza Vaccines

Intervention(s)

Biological: Influenza Vaccine

Primary Outcome(s)

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 Outcome(s)

To assess the long-term immunogenicity (6 months) of the cell-derived subunit vaccine. [Time Frame: 6 months]

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]

Secondary ID(s)

S203.2.009

2009-014767-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Quintiles