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

ISRCTN	ISRCTN33950739
DOI	https://doi.org/10.1186/ISRCTN33950739
Protocol serial number	INF-V-B001
Sponsor	Berna Biotech AG, Crucell Company (Switzerland)
Funder	Crucell B.V. (Netherlands)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Michael Seiberling
Scientific

Swiss Pharma Contract Ltd.
Lettenweg 118
Allschwil
4123
Switzerland

Primary study design	Interventional
Study design	Ramdomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Assessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administration
Study objectives	Intradermal administration requires smaller quantities of antigens compared to intramuscular administration to induce a similar immune response.
Ethics approval(s)	Ethics approval received from the Ethics Committee of Basel (Ethikkommission Beider Basel [EKBB]) (Switzerland) on the 16th July 2007 (ref: 165/07).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Influenza vaccine (Inflexal® V)
Primary outcome measure(s)	Immunogenicity, assessed by blood tests. Blood was collected before and approximately three weeks after vaccination.
Key secondary outcome measure(s)	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.
Completion date	30/06/2008

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	275
Key inclusion criteria	Healthy volunteers between 18 and 60 years of age.
Key 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
Date of first enrolment	03/09/2007
Date of final enrolment	30/06/2008

Swiss Pharma Contract Ltd.

Allschwil
4123
Switzerland

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	02/06/2009		Yes	No
Results article	results	23/07/2014		Yes	No