NCT00164411

Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine

Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (planned)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: All
• Age: 50 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Pneumococcal Infections

Interventions

Type	Name	Description
BIOLOGICAL	Tetanus-diphtheria toxoids (Td)
BIOLOGICAL	7-valent pneumococcal conjugate vaccine
BIOLOGICAL	23-valent polysaccharide vaccine

Timeline

• Start date: 2004-01-01
• Completion: 2005-03-01
• First posted: 2005-09-14
• Last updated: 2012-03-14

Locations

1 site across 1 country: United States