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
Secondary identifying numbers INF-V-B001
Submission date
24/09/2007
Registration date
14/11/2007
Last edited
16/01/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Michael Seiberling
Scientific

Swiss Pharma Contract Ltd.
Lettenweg 118
Allschwil
4123
Switzerland

Study information

Study designRamdomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleAssessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administration
Study objectivesIntradermal 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) studiedInfluenza
InterventionSingle-dose, intramuscular (0.5 mL) or intradermal (0.1 mL) administration of influenza vaccine (Inflexal® V).
Intervention typeDrug
Pharmaceutical study type(s)
PhasePhase II
Drug / device / biological / vaccine name(s)Influenza vaccine (Inflexal® V)
Primary outcome measureImmunogenicity, assessed by blood tests. Blood was collected before and approximately three weeks after vaccination.
Secondary outcome measuresSafety 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 study start date03/09/2007
Completion date30/06/2008

Eligibility

Participant type(s)Healthy volunteer
Age groupAdult
Lower age limit18 Years
Upper age limit60 Years
SexBoth
Target number of participants275
Key inclusion criteriaHealthy volunteers between 18 and 60 years of age.
Key exclusion criteria1. 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 enrolment03/09/2007
Date of final enrolment30/06/2008

Locations

Countries of recruitment

  • Switzerland

Study participating centre

Swiss Pharma Contract Ltd.
Allschwil
4123
Switzerland

Sponsor information

Berna Biotech AG, Crucell Company (Switzerland)
Industry

Rehhagstrasse 79
Berne
3018
Switzerland

Email info@bernabiotech.com

Funders

Funder type

Industry

Crucell B.V. (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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