Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000387426
Ethics application status
Approved
Date submitted
16/07/2007
Date registered
24/07/2007
Date last updated
11/03/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
The immunogenicity of the new pneumococcal conjugate vaccine in the elderly
Scientific title
The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in vulnerable elderly populations at high risk for invasive Pneumococcal disease.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pneumococcal disease 1969 0
Condition category
Condition code
Infection 2067 2067 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are two groups in this study;
1. The control group which received the 23- pneumococcal polysaccharide vaccine (23PPV, a dose of 0.5ml- Intramuscular injection)
2. The other is the intervention group that received the 7-valent pneumococcal conjugate vaccine ( PCV7, a dose of 0.5ml - Intramuscular injection) followed by the 23PPV (0.5ml- Intramuscular injection) at six months after the first dose.
All subjects in the PCV7 arm (i.e. receiving the new vaccine), will also receive 23 PPV six months later as it is normally recommended for all adults aged >65 years and is proven to be effective in preventing the invasive pneumococcal disease (IPD). Therefore, no study subject will be denied the recommended vaccine, and all subjects stand to benefit, as they are unvaccinated at the time of enrolment, and would not have received vaccination otherwise
Intervention code [1] 1889 0
Prevention
Comparator / control treatment
The control group which received the 23- pneumococcal polysaccharide vaccine (23PPV, a dose of 0.5ml- Intramuscular injection).
Control group
Active

Outcomes
Primary outcome [1] 3152 0
Immunogenicity (Protein conjugate pneumococcal vaccines are likely to be more
immunogenic in adults)
Timepoint [1] 3152 0
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 [1] 4896 0
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
Timepoint [1] 4896 0
To be done at 12 months only

Eligibility
Key inclusion criteria
Hospitalized patients
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation, Factors for gender is used for the stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Subjects will be initially blinded for the 1st vaccine dose, but it will not be possible to blind patients in the long term, since one arm receives a single vaccine and the other arm receives two vaccinations, 6 months apart. Whereas people assessing the
Phase
Phase 3 / Phase 4
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
16/05/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
315
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2213 0
Government body
Name [1] 2213 0
National Health and Medical Research Council (NHMRC)
Country [1] 2213 0
Australia
Primary sponsor type
Individual
Name
Professor C Raina MacIntyre
Address
The National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
CSB Level 2
Children's Hospital at Westmead
Country
Australia
Secondary sponsor category [1] 1996 0
None
Name [1] 1996 0
Nil
Address [1] 1996 0
Country [1] 1996 0
Other collaborator category [1] 1 0
Hospital
Name [1] 1 0
Richard Lindley
Professor of Geriatric Medicine
Moran Foundation for Older Australians
Address [1] 1 0
Department of Geriatric Medicine
Westmead Hospital
Hawkesbury Road
Westmead NSW 2145
Country [1] 1 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4402 0
Sydney West Area Health Service at Westmead Hospital
Ethics committee address [1] 4402 0
Ethics committee country [1] 4402 0
Australia
Date submitted for ethics approval [1] 4402 0
Approval date [1] 4402 0
Ethics approval number [1] 4402 0
HS/TG HRE2005/2/3.4 (1985)

Summary
Brief summary
Null hypothesis: That PCV7, given alone or followed by a dose of PPV, does not confer any additional benefit to that offered by PPV alone for the same serotypes of S. pneumoniae in hospitalised elderly adults.

Study short description
The bacteria pneumococcus is the most common cause of pneumonia, and a major cause of illness in elderly Australians. It can be prevented by vaccination. The NHMRC of Australia recommends that all adults > 65 years be immunised with the pneumococcal vaccine, which has been available for a long time in Australia. It is least effective in those at greatest risk, the elderly.
A new vaccine was developed for children, but has not been extensively tested in adults. This vaccine is much more effective in children than the old vaccine, and is now routinely used in children. Our study aims to compare the old vaccine with this new vaccine in hospitalized, sick elderly patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27703 0
Address 27703 0
Country 27703 0
Phone 27703 0
Fax 27703 0
Email 27703 0
Contact person for public queries
Name 11078 0
Iman Ridda
Address 11078 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children Hospital at Westmead
Cnr Hawkesbury Rd & Hainsworth St
Westmead NSW 2145
Country 11078 0
Australia
Phone 11078 0
+61 2 98451432
Fax 11078 0
Email 11078 0
[email protected]
Contact person for scientific queries
Name 2006 0
Prof Raina MacIntyre
Address 2006 0
National Centre for Immunisation Research and Surveillance of Vaccine Preventable Diseases
The Children Hospital at Westmead.
Cnr Hawkesbury Rd & Hainsworth St
Westmead NSW 2145
Country 2006 0
Australia
Phone 2006 0
+61 2 98451414
Fax 2006 0
+61 2 98451418
Email 2006 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.