Herpes ZosterPhase 3NCT00322231
A Study of an Investigational Zoster Vaccine, in Subjects With a History of Herpes Zoster (V211-014)
A Phase 3 study testing zoster vaccine live (ZOSTAVAX™) in people with Herpes Zoster, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster. 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
- What is being tested?
- zoster vaccine live (ZOSTAVAX™)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 2007
- Phase
- Phase 3
- 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
- Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
Who cannot join
- History of allergy to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Ability to defend against infection is suppressed by a medical condition or medication
About this study
Official title: A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
- Conditions
- Herpes Zoster
- Being tested
- zoster vaccine live (ZOSTAVAX™), Comparator: Placebo
- 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 live (ZOSTAVAX™)Biological
Also called Zostavax
1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live
Comparator: PlaceboBiological
1 dose 0.65 mL/dose subcutaneous injection of placebo.
| Study group | Role | What they receive |
|---|---|---|
| ZOSTAVAX™ / Placebo | Experimental | Zoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2) Receives: Biological: zoster vaccine live (ZOSTAVAX™); Biological: Comparator: Placebo |
| Placebo / ZOSTAVAX™ | Experimental | Placebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2) Receives: Biological: zoster vaccine live (ZOSTAVAX™); Biological: Comparator: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
Measured: To Day 28 postvaccination
Secondary outcomes (2)
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
The GMT of the VZV-specific antibody responses as measured by gpELISA (glycoprotein enzyme-linked immunosorbent assay) at the prespecified day ranges at prevaccination and 4 weeks postvaccination
Measured: 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
GMFR of the VZV antibody response at the prespecified day ranges prevaccination and 4 weeks postvaccination
Measured: From prevaccination (baseline) to 4 weeks postvaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionJul 2007
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322231
- Sponsor's protocol ID
- V211-014
- Other IDs
- 2006_010
- Status last verified
- Jan 2015
- First submitted
- 2 May 2006
- Last updated
- 26 Jan 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
PubMed 20416263
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live in Subjects With a History of Herpes Zoster
- ClinicalTrials.gov ID
- NCT00322231
- Acronym / sponsor ID
- V211-014
- Conditions
- Herpes Zoster
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 May 2006 (estimated)
- Results
- Posted 15 Dec 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the investigational zoster vaccine, is generally well tolerated when administered to participants with a history of herpes zoster.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ZOSTAVAX™ / Placebo | Experimental | Biological: zoster vaccine live (ZOSTAVAX™), Biological: Comparator: PlaceboZoster vaccine live on Day 1 (Period 1), placebo on Week 4 (Period 2) |
| Placebo / ZOSTAVAX™ | Experimental | Biological: zoster vaccine live (ZOSTAVAX™), Biological: Comparator: PlaceboPlacebo on Day 1 (Period 1), zoster vaccine live on Week 4 (Period 2) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults ≥ 50 years of age with a history of herpes zoster ≥ 5 years prior to enrollment
Key exclusion criteria (3 listed)
- History of allergy to any vaccine component
- Prior receipt of a varicella or zoster vaccine
- Ability to defend against infection is suppressed by a medical condition or medication
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 live (ZOSTAVAX™)Also: Zostavax1 dose 0.65 mL/dose subcutaneous injection of zoster vaccine live | Biological | Placebo / ZOSTAVAX™, ZOSTAVAX™ / Placebo |
| Comparator: Placebo1 dose 0.65 mL/dose subcutaneous injection of placebo. | Biological | Placebo / ZOSTAVAX™, ZOSTAVAX™ / Placebo |
Primary outcome
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination
Time frame: To Day 28 postvaccination
SAEs are AEs at any dose that: Results in death or persistent/significant disability/incapacity; or prolongs an existing inpatient hospitalization or Is life threatening; or Is a congenital anomaly/birth defect; or Is a cancer; or Is an overdose or Is an other important medical event
2 secondary outcomes
Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Time frame: 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Prevaccination to 4 Weeks Postvaccination
Time frame: From prevaccination (baseline) to 4 weeks postvaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20416263Mills R, Tyring SK, Levin MJ, Parrino J, Li X, Coll KE, Stek JE, Schlienger K, Chan IS, Silber JL. Safety, tolerability, and immunogenicity of zoster vaccine in subjects with a history of herpes zoster. Vaccine. 2010 Jun 7;28(25):4204-9. doi: 10.1016/j.vaccine.2010.04.003. Epub 2010 Apr 21.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing zoster vaccine live (ZOSTAVAX™) in people with Herpes Zoster, 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 1 inclusion and 3 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 26 Jan 2015. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 15 Dec 2010). 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?
Vaccine-related Serious Adverse Experiences (SAEs) for 28 Days Postvaccination (time frame: To Day 28 postvaccination). 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 NCT00322231, 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 26 Jan 2015; AzTrials last refreshed its copy on 8 Nov 2026.