A Lot-to-Lot Consistency Study to Evaluate Safety, Tolerability, and Immunogenicity of Inactivated Varicella Zoster Virus (VZV) Vaccine in Healthy Adults (V212-014)
A Phase III, Double-Blind, Lot-To-Lot Consistency Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of V212 in Healthy Adults
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jul 2014
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 1, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedFirst Posted
Study publicly available on registry
July 2, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedAugust 13, 2015
August 1, 2015
8 months
July 1, 2014
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Geometric Mean Titer of VZV Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titers
28 days postdose 4
Secondary Outcomes (1)
Percentage of Participants with a Serious Adverse Experience
Up to 28 days postdose 4
Study Arms (3)
V212 Lot 1
EXPERIMENTALApproximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
V212 Lot 2
EXPERIMENTALApproximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
V212 Lot 3
EXPERIMENTALApproximately 7.5 Units/0.5 mL subcutaneous injection administered in a 4-dose regimen given approximately 30 days apart
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.
PMID: 37781954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 1, 2014
First Posted
July 2, 2014
Study Start
July 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
August 13, 2015
Record last verified: 2015-08