Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations

Assessment of the immunogenicity and safety of the Northern Hemisphere 2010/2011-season influenza vaccine in elderly and young subjects according to European Medicines Agency (EMEA) regulations: an open label, non-randomised uncontrolled safety and efficacy study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN89337058

Enrollment

110

Registered

2011-01-21

Start date

2010-06-01

Completion date

Unknown

Last updated

2023-02-20

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

Primary

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

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.	—

Countries

Switzerland

Outcome results

None listed

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