A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)

Herpes Zoster Clinical Trial

Official title:

A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02180295
• Other study ID #: V212-014
• Secondary ID: 2014-001030-29
• Status: Withdrawn
• Phase: Phase 3
• First received: July 1, 2014
• Last updated: August 11, 2015
• Start date: July 2014
• Est. completion date: March 2015

Study information

• Verified date: August 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 study will evaluate the consistency of 3 lots of inactivated VZV vaccine for safety, tolerability, and immunogenicity in healthy adults. The primary hypothesis of the study is that the 3 lots of inactivated vaccine will demonstrate similar immunogenicity at 28 days after the fourth dose.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 59 Years

Eligibility

Inclusion Criteria:

• Afebrile (<=100.4 °F [<=38.0 °C]) oral or equivalent on Day 1 before the first vaccination

• Any underlying chronic illness that is not in stable condition

• History of varicella, antibodies to VZV, or residence (for >=30 years) in a country with endemic VZV infection

• Female participants of childbearing potential must have a negative pregnancy test. A female not of reproductive potential has reached natural menopause, or is 6-weeks postsurgical bilateral oophorectomy and/or hysterectomy or bilateral tubal ligation

• Male, or female of childbearing potential who agrees to remain abstinent or use 2 acceptable methods of birth control from 2 weeks before enrollment to 6 months after the last study vaccination

Exclusion Criteria:

• History of allergic reaction to any vaccine component, or an anaphylactic/anaphylactoid reaction to neomycin (not including contact dermatitis to neomycin)

• Prior history of herpes zoster

• History of receipt or expects to receive any varicella or zoster vaccine during the study period

• Is pregnant or breastfeeding, or expects to conceive from 2 weeks before enrollment to 6 months after the last study vaccination

• Has received a live virus vaccine or is scheduled to receive any live virus vaccine from 4 weeks before the first dose of study vaccination and throughout the study

• Has received any inactivated vaccine or is scheduled to receive any inactivated vaccine from 7 days before to 7 days after any study vaccination

• Received immunoglobulin or any blood products or is scheduled to receive them from 5 months before the first dose of study vaccination and throughout the study

• Has participated in an investigational drug or vaccine study within 30 days before enrollment

• Has any acute illness or significant underlying illness that may interfere with interpretation of the study

• Receiving immunosuppressive therapy (including systemic corticosteroid doses exceeding physiological replacement doses within 14 days prior to the first vaccination), except topical, ophthalmic, or inhaled corticosteroids or intra-articular or soft-tissue injections of steroids

• Has known or suspected immune dysfunction

Study Design

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

Related Conditions & MeSH terms

• Herpes Zoster

Intervention

Biological:
• V212 Lot 1
Inactivated Varicella Zoster Virus vaccine
• V212 Lot 2
Inactivated Varicella Zoster Virus vaccine
• V212 Lot 3
Inactivated Varicella Zoster Virus vaccine

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers		28 days postdose 4	No
Secondary	Percentage of Participants with a Serious Adverse Experience		Up to 28 days postdose 4	Yes