Revaccination With PNEUMOVAX(TM) 23 in Older Adults (V110-007)

Study Overview
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Brief Summary
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The purpose of this study is to determine that revaccination of Pneumococcal Vaccine is well tolerated and produces an immune response in older adults.

Detailed Description
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This study is an extension study (V110-007-10) which met requirements for posting on clinicaltrials.gov. The original study (V110-007-00) was completed in 2004 and did not meet the criteria for registration.

Official Title
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A Multicenter, Open-Label Study of the Safety, Tolerability, and Immunogenicity of Revaccination With PNEUMOVAX(TM) 23 Vaccine (Pneumococcal Vaccine Polyvalent, Merck & Co., Inc.) in Older Adults

Conditions
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Pneumococcal Infection

Intervention / Treatment
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* Biological: pneumococcal 23v polysaccharide vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal or negative urine pregnancy test if female No fever on the day of vaccination Exclusion Criteria: History of allergy to vaccine components History of pneumococcal disease Received any live virus vaccination within 4 weeks prior to study start Received any inactivated vaccination within 7 days prior to study start Received any blood products within 5 months prior to study start Participated in an investigational drug or vaccine study in the past 30 days Received immunosuppressive therapy Patient has an immune deficiency

Ages Eligible for Study
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Minimum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1st Revaccination Group<br> | Biological: pneumococcal 23v polysaccharide vaccine<br>* Duration of Treatment: Single vaccination on Day 1<br>* Other names: PNEUMOVAX;|
| Experimental: 2nd Revaccination Group<br> | Biological: pneumococcal 23v polysaccharide vaccine<br>* Duration of Treatment: Single vaccination on Day 1<br>* Other names: PNEUMOVAX;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 3 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B,8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 4 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 6B | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 8 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 9V | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 12F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 14 | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 | 
| Geometric Mean Concentration for Prevaccination (Day 1) to Postvaccination (Day 30) During the Extension Phase Subjects Completing the Extension for Serotype 23F | Blood drawn at Day 1 and Day 30 of the extension study were used to measure IgG antibody levels to 8 pneumococcal polysaccharide serotypes (3, 4, 6B, 8, 9V, 12F, 14, 23F) by ELISA. | Day 1 & Day 30 |