The immunogenicity of the new pneumococcal conjugate vaccine in the elderly
Phase 3
Completed
- Conditions
- Pneumococcal diseaseInfection - 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
Name Time Method 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
Name Time Method 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]