Safety, Tolerability, and Immunogenicity of Zoster Vaccine Live (ZOSTAVAX™) in Healthy Adults in India (V211-025)

Herpes Zoster Clinical Trial

Official title:

A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in India

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01527370
• Other study ID #: V211-025
• Secondary ID: CTRI/2012/08/002
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2012
• Est. completion date: April 9, 2013

Study information

• Verified date: August 2018
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will determine if ZOSTAVAX™ is safe, tolerable, and immunogenic in healthy adults in India.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 9, 2013
• Est. primary completion date: April 9, 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• No fever on day of vaccination

• Females have a negative pregnancy test and use an acceptable method of birth control, or are postmenopausal

• Underlying chronic illnesses must be stable

Exclusion Criteria:

• History of hypersensitivity reaction to any vaccine component

• Prior receipt of a varicella or zoster vaccine

• Prior history of herpes zoster

• Have recently had another vaccination

• Have recently received blood products other than autologous blood transfusion

• Pregnant or breast feeding

• Use of immunosuppressive therapy

• Known or suspected immune dysfunction

• Use of nontopical antiviral therapy with activity against herpesvirus

Related Conditions & MeSH terms

• Herpes Zoster
• Shingles

Intervention

Biological:
• Zoster Vaccine Live
One approximately 0.65 mL injection subcutaneously on Day 1

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated Varicella-Zoster Virus Vaccine (ZOSTAVAX™) in Healthy Adults in India. J Assoc Physicians India. 2018;66:50

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody at 6 Weeks Postvaccination	Antibody titers were measured by VZV-specific glycoprotein enzyme-linked immunosorbent assay (gpELISA).	Prevaccination up to 6 weeks postvaccination
Primary	Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers at 6 Weeks Postvaccination	GMFR was analyzed as the geometric mean of the ratio of VZV antibody titer (gpELISA units/mL) at postvaccination week 6 over VZV antibody titer (gpELISA units/mL) at prevaccination day 1.	Prevaccination up to 6 weeks postvaccination
Primary	Number of Participants With Serious Adverse Events	A serious adverse event is one that results in death, is life-threatening, results in a persistent or significant disability, results in or prolongs hospitalization, results in a congenital anomaly/birth defect, is a cancer, is an overdose, or is considered an "other important medical event" based on medical judgment.	Up to 42 days postvaccination