Herpes ZosterPhase 4NCT01556451
ZOSTAVAX™ Safety and Immunogenicity in Korean Adults (V211-034)
A Phase 4 study testing Zoster Vaccine Live in people with Herpes Zoster and Shingles, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Herpes Zoster, Shingles
- What is being tested?
- Zoster Vaccine Live
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 illness must be stable
Who cannot join
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster
- Prior receipt of varicella or zoster vaccine
- Pregnant or breastfeeding
- Have recently received immunoglobulins or blood products other than autologous blood transfusion
- Received any inactivated other live virus vaccine within 4 weeks prior to vaccination, or is expected to received any other live virus vaccine during the duration of the study
Show all 11Show fewer
- Received any inactivated vaccine within 7 days prior to vaccination, or is expected to receive any inactivated vaccine during the duration of the study
- Use of immunosuppressive therapy
- Known or suspected immune dysfunction
- Use of nontopical antiviral therapy with activity against herpes virus
- Known or suspected active untreated tuberculosis
About this study
Official title: An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.
- Conditions
- Herpes Zoster, Shingles
- Being tested
- Zoster Vaccine Live
- Medical subject headings
- Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoster Vaccine LiveBiological
Also called ZOSTAVAX™, V211
Zoster vaccine live
| Study group | Role | What they receive |
|---|---|---|
| Zoster Vaccine Live | Experimental | Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 Receives: Biological: Zoster Vaccine Live |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).
Measured: Day 1 (Baseline) and Week 4 postvaccination
Geometric Mean Titer (GMT) of VZV Antibody
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Measured: Day 1 (Baseline) and 4 weeks postvaccination
Percentage of Participants With Clinical Adverse Experiences
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Measured: Up to 42 days postvaccination
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
Measured: Up to 42 days postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2012
- Study completionOct 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Herpes ZosterStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01556451
- Sponsor's protocol ID
- V211-034
- Status last verified
- Mar 2017
- First submitted
- 17 Feb 2012
- Last updated
- 12 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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
Publications
Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.
PubMed 26770032
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multi-center, Phase IV Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ in Healthy Adults in Korea
- ClinicalTrials.gov ID
- NCT01556451
- Acronym / sponsor ID
- V211-034
- Conditions
- Herpes Zoster, Shingles
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Mar 2012 (estimated)
- Results
- Posted 23 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and immunogenicity of ZOSTAVAX™ in Korean adults. Approximately 180 herpes zoster history negative subjects ≥ 50 years of age will be enrolled in the study. Each subject will receive a single dose of ZOSTAVAX™. No statistical hypothesis testing will be conducted in the study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zoster Vaccine Live | Experimental | Biological: Zoster Vaccine LiveSingle subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 illness must be stable
Key exclusion criteria (11 listed)
- History of hypersensitivity reaction to any vaccine component
- Prior history of herpes zoster
- Prior receipt of varicella or zoster vaccine
- Pregnant or breastfeeding
- Have recently received immunoglobulins or blood products other than autologous blood transfusion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zoster Vaccine LiveAlso: ZOSTAVAX™, V211Zoster vaccine live | Biological | Zoster Vaccine Live |
Primary outcome
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody
Time frame: Day 1 (Baseline) and Week 4 postvaccination
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a glycoprotein enzyme-linked immunosorbent assay (gpELISA) to detect Immunoglobulin G antibody to VZV. The GMFR reports the geometric mean of the ratio of individual participant VZV antibody titers at Week 4 postvaccination / Day 1 (Baseline).
Geometric Mean Titer (GMT) of VZV Antibody
Time frame: Day 1 (Baseline) and 4 weeks postvaccination
Blood samples collected prevaccination on Day 1 and Week 4 postvaccination were analyzed using a gpELISA to detect Immunoglobulin G antibody to VZV
Percentage of Participants With Clinical Adverse Experiences
Time frame: Up to 42 days postvaccination
An adverse experience was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an adverse experience.
Percentage of Participants Discontinued Due to Clinical Adverse Experiences
Time frame: Up to 42 days postvaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26770032Choi WS, Choi JH, Choi JY, Eom JS, Kim SI, Pai H, Peck KR, Sohn JW, Cheong HJ. Immunogenicity and Safety of a Live Attenuated Zoster Vaccine (ZOSTAVAX) in Korean Adults. J Korean Med Sci. 2016 Jan;31(1):13-7. doi: 10.3346/jkms.2016.31.1.13. Epub 2015 Dec 24.
- Individual participant dataSharing planned: Yes. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Zoster Vaccine Live in people with Herpes Zoster and Shingles, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Fold Rise (GMFR) From Day 1 in Varicella Zoster Virus (VZV) Antibody (time frame: Day 1 (Baseline) and Week 4 postvaccination). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01556451, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017; AzTrials last refreshed its copy on 8 Nov 2026.