Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
1 other identifier
interventional
611
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2004
Longer than P75 for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedMarch 28, 2012
March 1, 2012
4.9 years
September 12, 2005
March 27, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Immunogenicity
ELISA based asssay for serotype specific pneumococcal responses
Completed by dec 2008
Interventions
Pneumococcal conjugate vaccine
Eligibility Criteria
You may qualify if:
- Written informed consent for participation in the study; ages between 50 and 80 years at recruitment
You may not qualify if:
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Goldblatt D, Southern J, Andrews N, Ashton L, Burbidge P, Woodgate S, Pebody R, Miller E. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009 Nov 1;49(9):1318-25. doi: 10.1086/606046.
PMID: 19814624DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elizabeth Miller, MBBS FRCPath
Heath Protection Agency
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant epidemiologist
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
January 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
March 28, 2012
Record last verified: 2012-03