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A Phase IV, single group study to evaluate the immune response to licensed seasonal influenza vaccine and relationship of this to cytomegalovirus-associated immunosenescence in UK older adults aged 50-80 years.

A Phase IV, single group study to evaluate the immune response to licensed seasonal influenza vaccine and relationship of this to cytomegalovirus-associated immunosenescence in UK older adults aged 50-80 years.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-006563-23-GB
Enrollment
200
Registered
2007-01-09
Start date
2007-02-07
Completion date
Unknown
Last updated
2019-04-30

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

Conditions

The vaccine is designed to provide protection against circulating influenza and is being used in the UK influnza immunisation programme 2006-7 MedDRA version: 8.1 Level: LLT Classification code 10022000 Term: Influenza

Interventions

Trade Name: Fluarix Product Name: Fluarix Pharmaceutical Form: Injection*

Sponsors

Health Protection Agency
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: • No contraindications to vaccination as specified in the “Green Book” – Immunisation Against Infectious Disease, HMSO. • Written informed consent obtained • Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrolment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: none

Design outcomes

Primary

MeasureTime frame
Main Objective: Primary objective: to estimate the geometric mean influenza antibody titres with 95% confidence intervals within CMV positive and negative individuals ; Secondary Objective: Secondary objective: to compare the geometric mean influenza antibody levels between CMV positive and negative individuals and calculate the fold difference with 95% confidence interval ;Primary end point(s): Level of IgG antibodies against HCMV (by enzymeimmunoassay)—

Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026