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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00535730
First received: September 21, 2007
Last updated: March 1, 2013
Last verified: March 2013
History of Changes
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination [ Time Frame: 4 weeks postvaccination ] [ Designated as safety issue: No ]

    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. [ Time Frame: Four weeks postvaccination ] [ Designated as safety issue: No ]

    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. [ Time Frame: Four weeks postvaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Four weeks postvaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Four weeks postvaccination ] [ Designated as safety issue: No ]
    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. [ Time Frame: Four weeks postvaccination ] [ Designated as safety issue: No ]
    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:
  • Safety and Tolerability of Both Vaccines When Administered Concomitantly. [ Time Frame: Eight weeks postvaccination ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 473
Study Start Date: June 2007
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535730

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00535730     History of Changes
Other Study ID Numbers: 2007_592, V211-012
Study First Received: September 21, 2007
Results First Received: January 21, 2009
Last Updated: March 1, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Herpes Zoster
Pneumococcal Infections
Herpesviridae Infections
DNA Virus Infections
 Virus Diseases
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 23, 2013