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

Phase 3

Completed

• Conditions: Herpes Zoster; Pneumococcal Infection
• Interventions: Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

• Registration Number: NCT00535730
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-26
• Primary Completion: 2008-02
• Study Completion: 2008-02
• Results First Submitted: 2009-01-21
• Results First Submitted QC: 2009-05-12
• Results First Posted: 2009-05-13
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-14
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 473

Inclusion Criteria

• 60 years of age or older
• Stable underlying conditions
• Postmenopausal if female
• Afebrile

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Exclusion Criteria

• Previously vaccinated with either vaccine
• Immune deficiency
• History of allergy to components in either vaccine
• Concomitant antiviral therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™	Placebo Comparator
2	Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™	vaccine
2	Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23	vaccine

Primary Outcome Measures

Name	Time	Method
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination	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
Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.	Four 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.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.	Four 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.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.	Four 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.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.	Four 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.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.	Four 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.

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability of Both Vaccines When Administered Concomitantly.	Eight weeks postvaccination	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.