Streptococcus Pneumoniae
Conditions
Brief summary
To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.
Interventions
BIOLOGICALpneumococcal conjugate vaccine
Pneumococcal conjugate vaccine
Sponsors
Public Health England
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 79 Years
Healthy volunteers
Yes
Inclusion criteria
* Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
Exclusion criteria
* Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent. * Current participation in any other clinical trial * Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study) * Prior pneumococcal conjugate vaccine (PNC) * 23 valent pneumococcal vaccine(PPV) in last 5 years * Severe general or local reaction to a previous dose of PNC or PPV * Patients currently immunocompromised as listed in UK Handbook Immunisation Against Infectious Disease ed 1996 * Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study * Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook Immunisation Against Infectious Disease * Deferral of vaccination if acute systemic illness or temperature \>38C on day of vaccination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Completed by dec 2008 | ELISA based asssay for serotype specific pneumococcal responses |
Outcome results
None listed