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Zostavax® at Minimum Release Specification Approaching Expiry

This study has been completed.
Sponsor:
Information provided by:
Sanofi Pasteur MSD
ClinicalTrials.gov Identifier:
NCT00681031
First received: May 16, 2008
Last updated: April 3, 2009
Last verified: April 2009
History of Changes
  Purpose

Primary objective:

To demonstrate whether or not ZOSTAVAX® at minimum release specification approaching expiry potency elicits an acceptable Varicella-Zoster Virus (VZV) antibody fold rise (measured by gpELISA) from pre-vaccination to 4 weeks post-vaccination

Secondary objectives:

To describe the safety profile of ZOSTAVAX® at minimum release specification approaching expiry potency


Condition Intervention Phase
Herpes Zoster
 Biological: ZOSTAVAX®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:

MedlinePlus related topics: Shingles
U.S. FDA Resources

Further study details as provided by Sanofi Pasteur MSD:

Primary Outcome Measures:
  • geometric mean fold rise (GMFR) of VZV antibody titres from pre- to post-vaccination [ Time Frame: day 28 to day 35 ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: May 2008
Study Completion Date: October 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Biological: ZOSTAVAX®
    One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain,(live attenuated) not less than 19400 PFU
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject of either gender aged ≥50 years
  • Positive history of varicella or residence for >30 years in a country with endemic VZV infection
  • All females must be postmenopausal or have a negative serum or urine pregnancy test or acceptable method of birth control for three months after vaccination
  • Subject having signed the informed consent form prior to any study procedure

Exclusion Criteria:

  • Subject febrile within 72 hours prior to vaccination
  • Subject with a prior history of Herpes Zoster clinically diagnosed by a physician
  • Subject has previously received a varicella or zoster vaccine
  • Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
  • Subject received any other live virus vaccine within 4 weeks prior to vaccination, or is expected to receive any other live virus vaccine during the study
  • Subject received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
  • Subject is treated with immunoglobulins or any blood products, other than autologous blood transfusion, given during the 5 months prior to vaccination or is expected to be treated during the study
  • Subject is taking any non topical antiviral therapy with activity against herpesviruses.
  • Subject is on immunosuppressive therapy
  • Subject has known or suspected immune dysfunction caused by a medical condition, or any other cause
  • Subject has a history of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
  • Subject with known active tuberculosis
  • Subject with significant underlying illness preventing completion of the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681031

Locations
France
Angers, France
Sponsors and Collaborators
Sanofi Pasteur MSD
Investigators
Study Director: Anne FIQUET, MD SPMSD
  More Information

No publications provided by Sanofi Pasteur MSD

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Anne FIQUET MD, Sanofi Pasteur MSD
ClinicalTrials.gov Identifier: NCT00681031     History of Changes
Other Study ID Numbers: ZTV02C
Study First Received: May 16, 2008
Last Updated: April 3, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Herpes Zoster
Herpesviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 23, 2013