The immunogenicity of the new pneumococcal conjugate vaccine in the elderly

The immunogenicity of 7-valent pneumococcal conjugate vaccine (PCV-7) in vulnerable elderly populations at high risk for invasive Pneumococcal disease.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000387426

Enrollment

315

Registered

2007-07-24

Start date

2005-05-16

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Healthy volunteers

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

Outcome results