Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164411
Status:
COMPLETED
Last Update Posted:
2012-03-14
First Post:
2005-09-09
Brief Title:
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and TetanusDiphtheria Vaccine
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Pneumococcal Conjugate Vaccine Prevnar Wyeth With Pneumococcal Polysaccharide Vaccine 23-valent and TetanusDiphtheria Vaccine
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to learn whether or not giving a tetanusdiphtheria 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None