Condition category
Infections and Infestations
Date applied
24/09/2007
Date assigned
14/11/2007
Last edited
16/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Michael Seiberling

ORCID ID

Contact details

Swiss Pharma Contract Ltd.
Lettenweg 118
Allschwil
4123
Switzerland

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 measures

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

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

Results - basic reporting

Publication summary

2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19464535
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24930715

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes