Influence of pre-operative vaccination on immune response and post-operative infection rate

ISRCTN	ISRCTN16108096
DOI	https://doi.org/10.1186/ISRCTN16108096
EudraCT/CTIS number	2004-004352-40
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Claudia Spies
Scientific

Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany

Phone	+49 (030) 450 551001
Email	anaesth@charite.de

Study design	Prospective randomised double-blind placebo-controlled clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Influence of pre-operative vaccination on immune response and post-operative infection rate
Study objectives	Pre-operative vaccination with influenza antigen improves post-operative immune suppression.
Ethics approval(s)	Ethics board committee Berlin, Landesamt für Gesundheit und Soziales (LaGeSo), Berlin, 11/03/2005, ref: EA 1/048/04
Health condition(s) or problem(s) studied	Upper aerodigestive tract cancer undergoing surgery
Intervention	Vaccination with influenza haemagglutinin antigen versus a placebo control group.
Intervention type	Biological/Vaccine
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Influence of pre-operative vaccination on immune response.
Secondary outcome measures	Influence of pre-operative vaccination post-operative infection rate.
Overall study start date	01/11/2005
Completion date	01/01/2009

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 (75 as of 30/03/2009)
Key inclusion criteria	Tumour resection of upper aerodigestive tract.
Key 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
Date of first enrolment	01/11/2005
Date of final enrolment	01/01/2009

Charite Universitaetsmedizin Berlin

Berlin
13353
Germany

Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany)
University/education

c/o Prof. Claudia Spies
Department of Anaesthesiology and Intensive Care Medicine
Augustenburgerplatz 1
Berlin
13353
Germany

Website	http://www.charite.de/ch/anaest/
"ROR"	https://ror.org/001w7jn25

University/education

Charité Universitätsmedizin Berlin
Private sector organisation / For-profit companies (industry)

Intention to publish date
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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2015		Yes	No

16/05/2016: Publication reference added.

30/03/2009: the overall trial end date was changed from 01/09/2006 to 01/01/2009.