Effect of needle size on serum antibody responses and incidence of general reactions following routine immunisations in infants
ISRCTN | ISRCTN62032215 |
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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
Scientific
Oxford Vaccine Group
Room 4250, Level 4
University Department of Paediatrics
John Radclifffe Hospital
Oxford
OX3 9DU
United Kingdom
Phone | +44 01865 221229 |
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linda.diggle@paediatrics.ox.ac.uk |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
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 | 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 study start date | 20/01/2002 |
Completion date | 20/06/2003 |
Eligibility
Participant type(s) | Patient |
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Age group | Child |
Sex | Both |
Target number of participants | 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Oxford Vaccine Group
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Phone | +44 (0)20 7307 2622 |
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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 | |
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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 |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 16/09/2006 | Yes | No |