Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
Phase 2
Completed
- Conditions
- Streptococcus Pneumoniae
- Registration Number
- NCT00197821
- Lead Sponsor
- Public Health England
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 611
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Immunogenicity Completed by dec 2008 ELISA based asssay for serotype specific pneumococcal responses
- Secondary Outcome Measures
Name Time Method