Assessment of the humoral immune response and safety of reduced doses of influenza vaccine administered intradermally compared to intramuscular administration
ISRCTN | ISRCTN33950739 |
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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
Scientific
Swiss Pharma Contract Ltd.
Lettenweg 118
Allschwil
4123
Switzerland
Study information
Study design | Ramdomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Prevention |
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 |
Pharmaceutical study type(s) | |
Phase | Phase II |
Drug / device / biological / vaccine name(s) | 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 study start date | 03/09/2007 |
Completion date | 30/06/2008 |
Eligibility
Participant type(s) | Healthy volunteer |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 60 Years |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- Switzerland
Study participating centre
Swiss Pharma Contract Ltd.
Allschwil
4123
Switzerland
4123
Switzerland
Sponsor information
Berna Biotech AG, Crucell Company (Switzerland)
Industry
Industry
Rehhagstrasse 79
Berne
3018
Switzerland
info@bernabiotech.com |
Funders
Funder type
Industry
Crucell B.V. (Netherlands)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not 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 |