Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
INF-V-B001
Study information
Scientific title
Assessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administration
Acronym
Study hypothesis
Intradermal administration requires smaller quantities of antigens compared to intramuscular administration to induce a similar immune response.
Ethics approval
Ethics approval received from the Ethics Committee of Basel (Ethikkommission Beider Basel [EKBB]) (Switzerland) on the 16th July 2007 (ref: 165/07).
Study design
Ramdomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Influenza
Intervention
Single-dose, intramuscular (0.5 mL) or intradermal (0.1 mL) administration of influenza vaccine (Inflexal® V).
Intervention type
Drug
Phase
Phase II
Drug names
Influenza vaccine (Inflexal® V)
Primary outcome measure
Immunogenicity, assessed by blood tests. Blood was collected before and approximately three weeks after vaccination.
Secondary outcome measures
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.
Overall trial start date
03/09/2007
Overall trial end date
30/06/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Healthy volunteers between 18 and 60 years of age.
Participant type
Healthy volunteer
Age group
Adult
Gender
Both
Target number of participants
275
Participant 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
Recruitment start date
03/09/2007
Recruitment end date
30/06/2008
Locations
Countries of recruitment
Switzerland
Trial participating centre
Swiss Pharma Contract Ltd.
Allschwil
4123
Switzerland
Sponsor information
Organisation
Berna Biotech AG, Crucell Company (Switzerland)
Sponsor details
Rehhagstrasse 79
Berne
3018
Switzerland
-
info@bernabiotech.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Crucell B.V. (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19464535
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24930715
Publication citations
-
Results
Künzi V, Klap JM, Seiberling MK, Herzog C, Hartmann K, Kürsteiner O, Kompier R, Grimaldi R, Goudsmit J, Immunogenicity and safety of low dose virosomal adjuvanted influenza vaccine administered intradermally compared to intramuscular full dose administration., Vaccine, 2009, 27, 27, 3561-3567, doi: 10.1016/j.vaccine.2009.03.062.
-
Results
Levin Y, Kochba E, Kenney R, Clinical evaluation of a novel microneedle device for intradermal delivery of an influenza vaccine: are all delivery methods the same?, Vaccine, 2014, 32, 34, 4249-4252, doi: 10.1016/j.vaccine.2014.03.024.