Zostavax® at Minimum Release Specification Approaching Expiry (V211-044)

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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 glycoprotein Enzyme Linked ImmunoSorbent Assay [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 or disease	Intervention/treatment	Phase
Herpes Zoster	Biological: ZOSTAVAX®	Phase 4

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	96 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	An Open-label, Single-arm, Phase IV Study Assessing the Immunogenicity and Safety of ZOSTAVAX® at Minimum Release Specification Approaching Expiry Potency in Subjects ≥50 Years Old.
Actual Study Start Date :	May 31, 2008
Actual Primary Completion Date :	June 30, 2008
Actual Study Completion Date :	October 31, 2008

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: All Enrolled; Participants received a single dose (0.65 mL) of shingles (herpes zoster) vaccine (live) ZOSTAVAX® by subcutaneous injection at Visit 1 (Day 0)	Biological: ZOSTAVAX®; One dose (0.65 mL) contains: Varicella-zoster virus, Oka/Merck strain, (live attenuated) not less than 19400 PFU

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Geometric Mean Titre (GMT) of Varicella Antibodies [ Time Frame: Predose (Day 0) and Day 28-35 Post Dose ]
   Blood samples to determine the GMT of varicella antibodies taken pre-vaccination and again 28 to 35 days post vaccination. Titres determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA).

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	50 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Participant 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
• Participant having signed the informed consent form prior to any study procedure

Exclusion Criteria:

• Febrile within 72 hours prior to vaccination
• Prior history of Herpes Zoster clinically diagnosed by a physician
• Previously received a varicella or zoster vaccine
• Exposure to varicella or herpes-zoster within 4 weeks prior to vaccination
• 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
• Received any inactivated vaccine within 2 weeks prior to vaccination, or is expected to receive any inactivated vaccine during the study
• Was 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
• Taking any non topical antiviral therapy with activity against herpesviruses.
• On immunosuppressive therapy
• Known or suspected immune dysfunction caused by a medical condition, or any other cause
• History of hypersensitivity reaction or anaphylactoid reaction to any vaccine component, including gelatin or neomycin
• Known active tuberculosis
• Significant underlying illness preventing completion of the study

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators

Study Director:	Medical Director	Merck Sharp & Dohme Corp.

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arnou R, Fiquet A, Thomas S, Sadorge C. Immunogenicity and safety of ZOSTAVAX(®) approaching expiry potency in individuals aged ≥50 years. Hum Vaccin. 2011 Oct;7(10):1060-5. doi: 10.4161/hv.7.10.16480. Epub 2011 Oct 1.

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 ); 2007-006532-66 ( EudraCT Number )
First Posted:	May 20, 2008
Results First Posted:	September 26, 2017
Last Update Posted:	September 26, 2017
Last Verified:	August 2017

Studies a U.S. FDA-regulated Drug Product:		Yes
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

Herpes Zoster; Herpesviridae Infections; DNA Virus Infections; Virus Diseases