A Study of an Investigational Zoster Vaccine in Subjects With a History of Varicella (Chickenpox) Given Concomitantly With Another Vaccine (V211-011)

Herpes Zoster Clinical Trial

Official title:

A Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of V211 Administered Concomitantly Versus Nonconcomitantly With Influenza Virus Vaccine (Inactivated)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231816
• Other study ID #: V211-011
• Secondary ID: 2005_036
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: September 2, 2015
• Start date: September 2005
• Est. completion date: March 2006

Study information

• Verified date: September 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the investigational zoster vaccine has a comparable immune response (the body's ability to protect against disease) and safety profile when given concomitantly with another vaccine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 763
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• Adults 50 years of age or older

Exclusion Criteria:

• Prior history of Herpes Zoster (shingles)

• Prior receipt of varicella or zoster vaccine

• Immunosuppressed

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• ZOSTAVAX™ (concomitant)
a single administration of 0.65 mL subcutaneous injection of zoster vaccine live on Day 1 and placebo at Week 4
• Comparator: Influenza Vaccine
a single administration of 0.5 mL intramuscular injection of influenza vaccine (inactivated) at Day 1
• ZOSTAVAX™ (Nonconcomitant)
Placebo injection on Day 1 and a single administration of 0.65 mL subcutaneous injection of zoster vaccine live at Week 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (2)

Kerzner B, Murray AV, Cheng E, Ifle R, Harvey PR, Tomlinson M, Barben JL, Rarrick K, Stek JE, Chung MO, Schödel FP, Wang WW, Xu J, Chan IS, Silber JL, Schlienger K. Safety and immunogenicity profile of the concomitant administration of ZOSTAVAX and inactivated influenza vaccine in adults aged 50 and older. J Am Geriatr Soc. 2007 Oct;55(10):1499-507. — View Citation

Sutradhar SC, Wang WW, Schlienger K, Stek JE, Xu J, Chan IS, Silber JL. Comparison of the levels of immunogenicity and safety of Zostavax in adults 50 to 59 years old and in adults 60 years old or older. Clin Vaccine Immunol. 2009 May;16(5):646-52. doi: 10.1128/CVI.00407-08. Epub 2009 Mar 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Geometric Mean Fold Rise (GMFR) in VZV gpELISA Antibody Titers From Prevaccination to 4 Weeks Postvaccination	GMFR of the VZV gpELISA antibody titers from prevaccination; to 4 weeks postvaccination when ZOSTAVAX™ is administered concomitantly with influenza vaccine	prevaccination to 4 weeks postvaccination	No
Other	Geometric Mean Titers (GMTs) of H1N1 Strain Antibody Responses at 4 Weeks Postvaccination	GMT of the H1N1 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly	4 weeks postvaccination	No
Other	GMTs of H3N2 Strain Antibody Responses at 4 Weeks Postvaccination	GMT of the H3N2 strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly	4 weeks postvaccination	No
Other	GMTs of B Strain Antibody Responses at 4 Weeks Postvaccination	GMT of the B strain antibody responses at 4 weeks postvaccination in participants who receive ZOSTAVAX™ concomitantly with influenza vaccine and those who receive ZOSTAVAX™ and influenza vaccine nonconcomitantly	4 weeks postvaccination	No
Primary	Varicella-zoster Virus (VZV) Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Antibody Responses	The Geometric mean titer (GMT) of the VZV glycoprotein enzyme-linked immunosorbent assay (gpELISA) antibody responses at Week 4 postvaccination in participants who received ZOSTAVAX™ concomitantly with influenza vaccine was compared to that in subjects who received influenza vaccine and ZOSTAVAX™ nonconcomitantly.	4 weeks	No