ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older.

Official Title
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A Phase III Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With PNEUMOVAX™ 23 in Subjects 60 Years of Age and Older

Conditions
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Herpes Zoster, Pneumococcal Infection

Intervention / Treatment
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* Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™
* Biological: Comparator: placebo (concomitant-vaccine matched)
* Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years of age or older Stable underlying conditions Postmenopausal if female Afebrile Exclusion Criteria: Previously vaccinated with either vaccine Immune deficiency History of allergy to components in either vaccine Concomitant antiviral therapy

Ages Eligible for Study
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Minimum Age: 60 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo Comparator | Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™<br>* 0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period<br>* Other names: ZOSTAVAX™;Biological: Comparator: placebo (concomitant-vaccine matched)<br>* Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.<br>|
| Experimental: 2<br>vaccine | Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™<br>* 0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period<br>* Other names: ZOSTAVAX™;Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23<br>* Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.<br>* Other names: PNEUMOVAX™ 23;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination | GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. *gpELISA = glycoprotein enzyme-linked immunosorbent assay | 4 weeks postvaccination | 
| Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. | GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay. | Four weeks postvaccination | 
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination | 
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination | 
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination | 
| Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. | GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. | Four weeks postvaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Both Vaccines When Administered Concomitantly. | All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events. | Eight weeks postvaccination |