|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN62032215 |
|
Date of registration:
|
23/01/2004 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Effect of needle size on serum antibody responses and incidence of general reactions following routine immunisations in infants
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
20/01/2002 |
|
Target sample size:
|
696 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN62032215 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Linda
Diggle |
|
Address:
|
Oxford Vaccine Group
Room 4250, Level 4
University Department of Paediatrics
John Radclifffe Hospital
OX3 9DU
Oxford
United Kingdom |
|
Telephone:
|
+44 01865 221229 |
|
Email:
|
linda.diggle@paediatrics.ox.ac.uk |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: Healthy infants attending routine immunisation clinics at eight general practices.
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
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Vaccination
Infections and Infestations
Vaccination
|
|
Intervention(s)
|
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
|
|
Primary Outcome(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
|
|
Secondary Outcome(s)
|
|
Not provided at time of registration
|
|
Source(s) of Monetary Support
|
|
NHS Executive South East (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|