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Zostavax® at Minimum Release Specification Approaching Expiry
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00681031
First received: May 16, 2008
Last updated: March 14, 2017
Last verified: March 2017
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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: None (Open Label) Primary Purpose: Prevention |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- geometric mean fold rise (GMFR) of VZV antibody titres from pre- to post-vaccination [ Time Frame: day 28 to day 35 ]
| 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) |
| Sexes Eligible for Study: | All |
| 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
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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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00681031
Locations
| France | |
| Angers, France | |
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Anne FIQUET, MD | SPMSD |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00681031 History of Changes |
| Other Study ID Numbers: |
V211-044 ZTV02C ( Other Identifier: MCMVaccBV (SPMSD) Protocol Number ) |
| Study First Received: | May 16, 2008 |
| Last Updated: | March 14, 2017 |
Additional relevant MeSH terms:
|
Herpes Zoster Herpesviridae Infections DNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on September 21, 2017