A Randomised Comparative Study of Two Different Schedules for the Administration of anti-Pneumococcal Vaccine in Children receiving Haemopoietic Progenitor Transplants
| ISRCTN | ISRCTN21659163 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN21659163 |
| Protocol serial number | N0258123552 |
| Sponsor | Department of Health |
| Funder | The Royal Marsden NHS Trust (UK) |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 03/09/2012
- 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 Miguel Ortin
Scientific
Scientific
Paediatric Department
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8642 6011 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To determine the influence of different forms of transplant on the immunity against pneumococcus in children who had already acquired this immunity before transplant. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Infections and Infestations: Pneumococcal infections |
| Intervention | Randomised test intervention versus standardised intervention, non-blinded (Phase 3) |
| Intervention type | Drug |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Pneumococcal vaccine |
| Primary outcome measure(s) |
This study will determine the most efficacious way of administration of pneumococcal vaccine between the two given schedules. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Key inclusion criteria | Children receiving Haemopoietic Progenitor Transplants |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 12/02/2003 |
| Date of final enrolment | 31/03/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Paediatric Department
Sutton
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
