Vaccination Response in Immuno-Compromised Host 2
| ISRCTN | ISRCTN15762138 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15762138 |
| Protocol serial number | p05.115; NTR273 |
| Sponsor | Leiden University Medical Centre (LUMC) (Netherlands) |
| Funder | Leiden University Medical Centre (LUMC) (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 14/11/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr L.B.S. Gelinck
Scientific
Scientific
Leiden University Medical Centre (LUMC)
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 9111 |
|---|---|
| L.B.S.Gelinck@LUMC.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Comparison of antibody response upon influenza vaccination after intradermal versus intramuscular injection in immunocompromised hosts |
| Study acronym | RICH 2 |
| Study objectives | Intradermal vaccination with one fifth of the total vaccine dose intradermally is just as efficient as intramuscular vaccination with the regular dose. |
| Ethics approval(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Influenza vaccination response |
| Intervention | 1. Intradermal vaccination 2. Intramuscular vaccination |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Influenza vaccination |
| Primary outcome measure(s) |
Geometric mean titre (GMT) 30 days post-vaccination |
| Key secondary outcome measure(s) |
Protection rates |
| Completion date | 01/04/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 580 |
| Key inclusion criteria | Immunocompromised patients at least 18 years of age. |
| Key exclusion criteria | 1. Active infection 2. Pregnancy 3. Life expectancy of less than 6 months 4. Thrombocytopenia 5. Coumarin therapy 6. Thin skin with steroids 7. Known allergies 8. Influenza vaccination within last 9 months |
| Date of first enrolment | 04/10/2005 |
| Date of final enrolment | 01/04/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
