Status:
COMPLETED
Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
Lead Sponsor:
Public Health England
Conditions:
Streptococcus Pneumoniae
Eligibility:
All Genders
50-79 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT00197821
Start Date
January 1 2004
End Date
December 1 2008
Last Update
March 28 2012
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