Condition category
Cancer
Date applied
11/08/2006
Date assigned
29/01/2007
Last edited
16/05/2016
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

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

http://www.charite.de/ch/anaest/

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

Publication citations

Additional files

Editorial Notes

16/05/2016: Publication reference added. 30/03/2009: the overall trial end date was changed from 01/09/2006 to 01/01/2009.