Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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 September 27, 2016