Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
Primary Purpose
Pneumococcal Infections
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tetanus-diphtheria toxoids (Td)
7-valent pneumococcal conjugate vaccine
23-valent polysaccharide vaccine
Sponsored by
About this trial
This is an interventional prevention trial for Pneumococcal Infections focused on measuring Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity
Eligibility Criteria
Exclusion Criteria: Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start Any vaccination within 2 weeks prior to first study vaccine Evidence of systemic or local infection within one week prior to first study vaccine HIV infection Renal failure Receipt of a pneumococcal or Td vaccine within 5 years Current receipt of therapy for neoplastic disease Current receipt of immunosuppressive therapy Terminal illness withlife expectancy less than 3 months
Sites / Locations
- Emory University School of Medicine
Outcomes
Primary Outcome Measures
ELISA for S. pneumoniae antibody 2 months after receiving PPV23
Functional S. pneumoniae antibody 2 months after receiving PPV23
Secondary Outcome Measures
Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination
Full Information
NCT ID
NCT00164411
First Posted
September 9, 2005
Last Updated
March 13, 2012
Sponsor
Centers for Disease Control and Prevention
Collaborators
Emory University
1. Study Identification
Unique Protocol Identification Number
NCT00164411
Brief Title
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
Official Title
Pneumococcal Conjugate Vaccine (Prevnar; Wyeth) With Pneumococcal Polysaccharide Vaccine (23-valent) and Tetanus/Diphtheria Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
Emory University
4. Oversight
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Infections
Keywords
Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Tetanus-diphtheria toxoids (Td)
Intervention Type
Biological
Intervention Name(s)
7-valent pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
23-valent polysaccharide vaccine
Primary Outcome Measure Information:
Title
ELISA for S. pneumoniae antibody 2 months after receiving PPV23
Title
Functional S. pneumoniae antibody 2 months after receiving PPV23
Secondary Outcome Measure Information:
Title
Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Exclusion Criteria:
Participation in any other investigational clinical trials except purely observational studies within 4 weeks prior to study start
Any vaccination within 2 weeks prior to first study vaccine
Evidence of systemic or local infection within one week prior to first study vaccine
HIV infection
Renal failure
Receipt of a pneumococcal or Td vaccine within 5 years
Current receipt of therapy for neoplastic disease
Current receipt of immunosuppressive therapy
Terminal illness withlife expectancy less than 3 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harry L Keyserling, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pneumococcal Conjugate Vaccine With Pneumococcal Polysaccharide Vaccine and Tetanus/Diphtheria Vaccine
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