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

Study Overview
=================
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

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

Conditions
-----------------
Pneumococcal Infections

Intervention / Treatment
-----------------
* Biological: Tetanus-diphtheria toxoids (Td)
* Biological: 7-valent pneumococcal conjugate vaccine
* Biological: 23-valent polysaccharide vaccine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 64 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tetanus-diphtheria toxoids (Td)|nan|
|Biological: 7-valent pneumococcal conjugate vaccine|nan|
|Biological: 23-valent polysaccharide vaccine|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ELISA for S. pneumoniae antibody 2 months after receiving PPV23 |  |  | 
| Functional S. pneumoniae antibody 2 months after receiving PPV23 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events following vaccination from entry to 2 months after receiving last vaccination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diptheria-Tetanus vaccine, Pneumococcal vaccine, Adverse events following vaccination, Immunization, Immunogenicity