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
Secondary identifying numbers SEO232
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
22/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWhen 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) studiedVaccination
Intervention1. 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 typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date20/01/2002
Completion date20/06/2003

Eligibility

Participant type(s)Patient
Age groupChild
SexBoth
Target number of participants696
Key inclusion criteriaHealthy infants attending routine immunisation clinics at eight general practices.
Key exclusion criteria1. 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 enrolment20/01/2002
Date of final enrolment20/06/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Oxford Vaccine Group
Oxford
OX3 9DU
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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