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

NCT01527370 | Completed Phase 3 Results

• 2 other identifiers: V211-025CTRI/2012/08/002922
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Herpes Zoster; Shingles

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (1)

Zoster Vaccine Live

EXPERIMENTAL

Biological: Zoster Vaccine Live

Interventions

Zoster Vaccine Live BIOLOGICAL

One approximately 0.65 mL injection subcutaneously on Day 1

Also known as: ZOSTAVAX™, V211

Zoster Vaccine Live

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related Publications (1)

• Sreenivasamurthy L, Pandey S, Chandra BS, Sharma M, Ranganathaiah SR, Vaidya P, Naik R. Immunogenicity, Safety, and Tolerability of Live Attenuated VaricellaZoster Virus Vaccine (ZOSTAVAX) in Healthy Adults in India. J Assoc Physicians India. 2018 Jul;66(7):50-54.

  PMID: 31325263 RESULT

MeSH Terms

Conditions

Herpes Zoster

Interventions

Herpes Zoster Vaccine

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Chickenpox Vaccine; Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2012
• First Posted: February 7, 2012
• Study Start: October 31, 2012
• Primary Completion: April 9, 2013
• Study Completion: April 9, 2013
• Last Updated: September 18, 2018
• Results First Posted: December 30, 2013

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share