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

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ClinicalTrials.gov Identifier: NCT00535730
Recruitment Status : Completed
First Posted : September 26, 2007
Results First Posted : May 13, 2009
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Herpes Zoster Pneumococcal Infection Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ Biological: Comparator: placebo (concomitant-vaccine matched) Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 473 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : June 2007
Primary Completion Date : February 2008
Study Completion Date : February 2008


Arms and Interventions

Arm Intervention/treatment
Placebo Comparator: 1
Placebo Comparator
Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Other Name: ZOSTAVAX™
Biological: Comparator: placebo (concomitant-vaccine matched)
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
Experimental: 2
vaccine
Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Other Name: ZOSTAVAX™
Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.
Other Name: PNEUMOVAX™ 23


Outcome Measures

Primary Outcome Measures :
  1. Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 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


  2. Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination. [ Time Frame: 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.


  3. Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination. [ Time Frame: 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.

  4. Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination. [ Time Frame: 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.

  5. Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination. [ Time Frame: 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.

  6. Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination. [ Time Frame: 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 :
  1. Safety and Tolerability of Both Vaccines When Administered Concomitantly. [ Time Frame: 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00535730


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00535730     History of Changes
Other Study ID Numbers: V211-012
2007_592
First Posted: September 26, 2007    Key Record Dates
Results First Posted: May 13, 2009
Last Update Posted: April 12, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php


Additional relevant MeSH terms:
Herpes Zoster
Pneumococcal Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs