Effect of needle size on serum antibody responses and incidence of general reactions following routine immunisations in infants

ISRCTN	ISRCTN62032215
DOI	https://doi.org/10.1186/ISRCTN62032215
Protocol serial number	SEO232
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mrs Linda Diggle
Scientific

Oxford Vaccine Group
Room 4250, Level 4
University Department of Paediatrics
John Radclifffe Hospital
Oxford
OX3 9DU
United Kingdom

Phone	+44 01865 221229
Email	linda.diggle@paediatrics.ox.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	When giving routine immunisations to infants, does the needle size used to administer the vaccines affect the serum antibody responses and/or the incidence of local and general reactions.
Ethics approval(s)	This study was approved by the Mid and South Buckinghamshire and Oxfordshire local research ethics committees.
Health condition(s) or problem(s) studied	Vaccination
Intervention	1. 23 gauge 25 mm - wider gauge long needle 2. 25 gauge 16 mm - narrower gauge short needle 3. 25 gauge 25 mm - narrower gauge long needle
Intervention type	Other
Primary outcome measure(s)	1. Comparison of geometric mean titres of Diphtheria/Tetanus and Hib antibodies between needle size groups 2. Comparison of incidence of general and local reactions between needle size groups at three time points - following vaccination at two, three and four months
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	20/06/2003

Participant type(s)	Patient
Age group	Child
Sex	All
Target sample size at registration	696
Key inclusion criteria	Healthy infants attending routine immunisation clinics at eight general practices.
Key exclusion criteria	1. Infants with severe chronic disease 2. Infants who may receive treatment likely to alter the immune response or infants with any conditions which could preclude evaluation of the response, e.g. congenital or acquired immunodeficiency 3. Infants who have already received Diphtheria-Tetanus-Pertussis (DPT)/Hib vaccines
Date of first enrolment	20/01/2002
Date of final enrolment	20/06/2003

Oxford Vaccine Group

Oxford
OX3 9DU
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	16/09/2006		Yes	No