Assessment of the immunogenicity and safety of the Northern Hemisphere 2009/2010-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN30202688

Enrollment

110

Registered

2009-05-28

Start date

2009-06-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Influenza Infections and Infestations Influenza, virus not identified

Interventions

Biological: single dose of trivalent virosomal adjuvanted influenza vaccine (Inflexal® V). Total duration of follow-up: approximately three weeks

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Healthy female and male volunteers equal to or older than 18 years of age on the day of enrolment 2. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation 2. Serious adverse reaction to any influenza vaccine

Design outcomes

Secondary

Measure	Time frame
Safety, assessed at baseline and at three weeks after vaccination, including a four-day adverse event questionnaire, soliciting a set of local and systemic adverse events (AEs) according to the European Medicines Agency (EMEA) specifications.	—

Primary

Measure	Time frame
Immunogenicity, assessed by haemagglutination inhibition test; blood to be collected before and approximately three weeks after vaccination.	—

Countries

Switzerland

Outcome results

None listed

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