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
Secondary identifying numbers	N0258123552

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

Dr Miguel Ortin
Scientific

Paediatric Department
Royal Marsden NHS Trust
Downs Road
Sutton
SM2 5PT
United Kingdom

Phone	+44 (0)20 8642 6011

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Not Specified
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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	Pneumococcal vaccine
Primary outcome measure	This study will determine the most efficacious way of administration of pneumococcal vaccine between the two given schedules.
Secondary outcome measures	Not provided at time of registration
Overall study start date	12/02/2003
Completion date	31/03/2006

Participant type(s)	Patient
Age group	Child
Sex	Not Specified
Target number of participants	Not provided at time of registration
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

Paediatric Department

Sutton
SM2 5PT
United Kingdom

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Government

The Royal Marsden NHS Trust (UK)

No information available

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