Trial record 3 of 8 for:    merck v212

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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT02180295
First received: July 1, 2014
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Herpes Zoster
Biological: V212 Lot 1
Biological: V212 Lot 2
Biological: V212 Lot 3
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers [ Time Frame: 28 days postdose 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Participants with a Serious Adverse Experience [ Time Frame: Up to 28 days postdose 4 ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: V212 Lot 1
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 1
Inactivated Varicella Zoster Virus vaccine
Experimental: V212 Lot 2
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 2
Inactivated Varicella Zoster Virus vaccine
Experimental: V212 Lot 3
Approximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Biological: V212 Lot 3
Inactivated Varicella Zoster Virus vaccine

  Eligibility

Ages Eligible for Study:   50 Years to 59 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02180295

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Director Merck Sharp & Dohme Corp.
  More Information

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT02180295     History of Changes
Other Study ID Numbers: V212-014, 2014-001030-29
Study First Received: July 1, 2014
Last Updated: August 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Herpes Zoster
DNA Virus Infections
Herpesviridae Infections
Virus Diseases

ClinicalTrials.gov processed this record on July 27, 2015