Safety and Immunogenicity of Zoster Vaccine (ZOSTAVAX™) Made With an Alternative Manufacturing Process (AMP) (V211-042 AM1)
A Phase III Double-Blinded, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Made With an Alternative Manufacturing Process (AMP)
1 other identifier
interventional
498
0 countries
N/A
Brief Summary
This study will determine whether ZOSTAVAX™ made with an alternative manufacturing process \[ZOSTAVAX™ (AMP)\] is well tolerated and immunogenic, and has a comparable immune response to ZOSTAVAX™.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2012
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedResults Posted
Study results publicly available
July 3, 2013
CompletedApril 12, 2017
March 1, 2017
3 months
January 4, 2012
April 10, 2013
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Geometric Mean Titer (GMT) of Varicella-Zoster Virus (VZV) Antibody
VZV antibody titers were determined by glycoprotein enzyme-linked immunosorbent assay (gpELISA)
Day 1 and Week 6 postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers
VZV antibody titers were determined by gpELISA. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 6 / Day 1 (Baseline).
Day 1 (Baseline) to Week 6 postvaccination
Secondary Outcomes (3)
Number of Participants With One or More Adverse Experiences (AEs)
Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience (SAE) Day 1 to 42 Postvaccination
Day 1 to Day 42 postvaccination
Number of Participants With One or More Serious Adverse Experience Day 1 to 182 Postvaccination
Day 1 to Day 182 postvaccination
Study Arms (2)
ZOSTAVAX™ (AMP)
EXPERIMENTALZOSTAVAX™ manufactured with an alternative process
ZOSTAVAX™
ACTIVE COMPARATORZOSTAVAX™ manufactured with the current process
Interventions
One approximately 0.65-mL injection subcutaneously on Day 1
One approximately 0.65-mL injection subcutaneously on Day 1
Eligibility Criteria
You may qualify if:
- No fever on day of vaccination
- History of varicella or residence in a VZV-endemic area for ≥30 years
- Females of reproductive potential must have a negative pregnancy test and must agree to use acceptable methods of birth control
You may not qualify if:
- History of hypersensitivity reaction to any vaccine component
- Prior receipt of any varicella or zoster vaccine
- Prior history of herpes zoster
- Have recently had another vaccination
- Pregnant or breastfeeding
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Concomitant antiviral therapy
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2012
First Posted
January 6, 2012
Study Start
April 1, 2012
Primary Completion
July 1, 2012
Study Completion
November 1, 2012
Last Updated
April 12, 2017
Results First Posted
July 3, 2013
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php