Contact information
Type
Scientific
Primary contact
Mrs Linda Diggle
ORCID ID
Contact details
Oxford Vaccine Group
Room 4250
Level 4
University Department of Paediatrics
John Radclifffe Hospital
Oxford
OX3 9DU
United Kingdom
+44 01865 221229
linda.diggle@paediatrics.ox.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SEO232
Study information
Scientific title
Acronym
Study hypothesis
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
This study was approved by the Mid and South Buckinghamshire and Oxfordshire local research ethics committees.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
20/01/2002
Overall trial end date
20/06/2003
Reason abandoned
Eligibility
Participant inclusion criteria
Healthy infants attending routine immunisation clinics at eight general practices.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
696
Participant 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
Recruitment start date
20/01/2002
Recruitment end date
20/06/2003
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Oxford Vaccine Group
Oxford
OX3 9DU
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/16891328
Publication citations
-
Results
Diggle L, Deeks JJ, Pollard AJ, Effect of needle size on immunogenicity and reactogenicity of vaccines in infants: randomised controlled trial., BMJ, 2006, 333, 7568, 571, doi: 10.1136/bmj.38906.704549.7C.