Condition category
Infections and Infestations
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

  1. 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.

Additional files

Editorial Notes