Influence of pre-operative vaccination on immune response and post-operative infection rate
| ISRCTN | ISRCTN16108096 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16108096 |
| Clinical Trials Information System (CTIS) | 2004-004352-40 |
| Protocol serial number | N/A |
| Sponsor | Charité - University Medicine Berlin (Charité - Universitätsmedizin Berlin) (Germany) |
| Funder | Charité Universitätsmedizin Berlin |
- Submission date
- 11/08/2006
- Registration date
- 29/01/2007
- Last edited
- 16/05/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Claudia Spies
Scientific
Scientific
Department of Anaesthesiology and Intensive Care Medicine
Charite Universitaetsmedizin Berlin
Augustenburgerplatz 1
Berlin
13353
Germany
| Phone | +49 (030) 450 551001 |
|---|---|
| anaesth@charite.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised double-blind placebo-controlled clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Influence of pre-operative vaccination on immune response. |
| Key secondary outcome measure(s) |
Influence of pre-operative vaccination post-operative infection rate. |
| Completion date | 01/01/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 75 |
| 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Charite Universitaetsmedizin Berlin
Berlin
13353
Germany
13353
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/08/2015 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
