CompletedPhase 3Phase 4ACTRN12607000387426

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.

Sponsor

Professor C Raina MacIntyre

Enrollment

315 participants

Start Date

May 16, 2005

Study Type

Interventional

Conditions

Pneumococcal disease

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.

Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This study investigates the immunogenicity of the new pneumococcal conjugate vaccine in the elderly. It is looking for both men and women, aged 60 and older who have hospitalized patients. If you are interested, you may need to attend study visits and follow the research team's instructions.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 intervent

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