Assessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administration

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN33950739

Enrollment

275

Registered

2007-11-14

Start date

2007-09-03

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

Interventions

Single-dose, intramuscular (0.5 mL) or intradermal (0.1 mL) administration of influenza vaccine (Inflexal® V).

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Healthy volunteers between 18 and 60 years of age.

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation 2. Treatment with immunoglobulins or blood transfusions 3. Immunodeficiency 4. History of egg protein allergy/severe atopy/serious adverse reaction to influenza vaccine 5. Previous vaccination against influenza in the past 330 days 6. Participation in another clinical trial 7. Known blood coagulation disorders 8. Acute febrile illness

Design outcomes

Primary

Measure	Time frame
Immunogenicity, assessed by blood tests. Blood was collected before and approximately three weeks after vaccination.	—

Secondary

Measure	Time frame
Safety will be assessed at baseline and at 3 weeks after vaccination, including a 4-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