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The immunogenicity of the new pneumococcal conjugate vaccine in the elderly

Phase 3
Completed
Conditions
Pneumococcal disease
Infection - Studies of infection and infectious agents
Registration Number
ACTRN12607000387426
Lead Sponsor
Professor C Raina MacIntyre
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
315
Inclusion Criteria

Hospitalized patients

Exclusion Criteria

Younger than 60Previously vaccinated with pneumococcal vaccineAllergic reaction to one of the vaccine componentLife expectancy lees than 12 monthsSeen as unwell to be vaccinated

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Immunogenicity (Protein conjugate pneumococcal vaccines are likely to be more <br>immunogenic in adults)[For the PCV7 arm, immunogenicity to PCV7 alone will be measured at 6 months, after which a dose of PPV will be given. At 12 months, the immunogenicity of this PCV7-PPV schedule will be measured. For the PPV arm, immuogenicity to a single dose of PPV will be measured at 6 and 12 months.]
Secondary Outcome Measures
NameTimeMethod
Secondary outcome measures : using a subset of 30% of study participants: pneumococcal serotype specific IgG avidity after each dose to assess immunological memory, functional antibody assays using opsonophagocytosis[To be done at 12 months only]
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