Contact information
Type
Scientific
Primary contact
Prof Claudia Spies
ORCID ID
Contact details
Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany
+49 (030) 450 551001
anaesth@charite.de
Additional identifiers
EudraCT number
2004-004352-40
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Influence of pre-operative vaccination on immune response and post-operative infection rate
Acronym
Study hypothesis
Pre-operative vaccination with influenza antigen improves post-operative immune suppression.
Ethics approval
Ethics board committee Berlin, Landesamt für Gesundheit und Soziales (LaGeSo), Berlin, 11/03/2005, ref: EA 1/048/04
Study design
Prospective randomised double-blind placebo-controlled clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Upper aerodigestive tract cancer undergoing surgery
Intervention
Vaccination with influenza haemagglutinin antigen versus a placebo control group.
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measures
Influence of pre-operative vaccination on immune response.
Secondary outcome measures
Influence of pre-operative vaccination post-operative infection rate.
Overall trial start date
01/11/2005
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Tumour resection of upper aerodigestive tract.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
40 (75 as of 30/03/2009)
Participant exclusion criteria
Initial information at time of registration:
1. No consent
2. Under 18 years
3. Liver insufficiency (more than Child B)
4. Acute Coronary Syndrome (less than 8 weeks)
5. Human Immunodeficiency Virus (HIV) positive
6. Corticosteriodal treatment
7. After organ transplantation
8. Current infection
9. Pregnancy
Added as of 30/03/2009:
10. Diabetes mellitus
11. Status post splenectomy
12. Protein deficiency
13. Known allergy to components of the vaccine
14. Immunosuppression
Recruitment start date
01/11/2005
Recruitment end date
01/01/2009
Locations
Countries of recruitment
Germany
Trial participating centre
Charite Universitaetsmedizin Berlin
Berlin
13353
Germany
Sponsor information
Organisation
Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
Sponsor details
c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburgerplatz 1
Berlin
13353
Germany
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Charité Universitätsmedizin Berlin
Alternative name(s)
Funding Body Type
private sector organisation
Funding Body Subtype
corporate
Location
Germany
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25564783