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Clinical Trial Summary

The purpose of this study is to learn whether or not giving a tetanus/diphtheria vaccination ("tetanus shot") before giving pneumococcal vaccine makes the pneumococcal vaccine more effective without causing too many side effects.


Clinical Trial Description

The only vaccine licensed in the United States for protecting adults against pneumococcal disease (PPV23) protects against invasive disease in observational studies but has generally been poorly effective against pneumonia or all-cause mortality in randomized clinical trials. Another vaccine containing seven polysaccharide antigens conjugated to diphtheria toxoid (PCV7) is licensed for children and under investigation in adults.

In this pilot study, we are comparing the safety and immunogenicity of three immunization schedules in adults:

- Td vaccine, 2-week interval, PCV7, 4-month interval, PPV23

- PCV7, 4-month interval, PPV23

- PPV23

We aim to:

- compare the safety profiles of pneumococcal vaccines given on each of the three schedules

- compare serotype-specific ELISA antibody response to pneumococcal antigens given on each of the three schedules

- compare functional serotype-specific antibody responses to pneumococcal antigens given on each of the three schedules

- study the influence of diphtheria antibody levels at the time of pneumococcal conjugate vaccine administration on the magnitude of the immune response to pneumococcal antigens ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


NCT number NCT00164411
Study type Interventional
Source Centers for Disease Control and Prevention
Contact
Status Completed
Phase Phase 1
Start date January 2004
Completion date March 2005

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