Varicella Virus InfectionPhase 3NCT00444860
ZOSTAVAX(R) Local Registration Trial (V211-019)
A Phase 3 study testing Zoster Vaccine, Live, (Oka-Merck) in people with Varicella Virus Infection, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Varicella Virus Infection
- What is being tested?
- Zoster Vaccine, Live, (Oka-Merck)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to May 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
- All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
- Postmenopausal Is Defined As 6 Months Of Spontaneous Amenorrhea With Serum Follicle Stimulating Hormone (Fsh) Levels In The Postmenopausal Range As Determined By The Laboratory, Or 12 Months Of Spontaneous Amenorrhea
- A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
- Acceptable Methods Of Birth Control Are: Intrauterine Device, Diaphragm With Spermicide, Contraceptive Sponge, Oral Contraceptive Pills, Condom, Tubal Ligation, And Vasectomy
- Subject Must Sign Informed Consent Prior To Any Study Procedure
- Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
- Any Underlying Chronic Illness Must Be In Stable Condition
Who cannot join
None listed.
About this study
Official title: A Phase III Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of ZOSTAVAX(R) in Healthy Adults in Taiwan
The purpose of this study is to obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
- Conditions
- Varicella Virus Infection
- Being tested
- Zoster Vaccine, Live, (Oka-Merck)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zoster Vaccine, Live, (Oka-Merck)Biological
Also called Zostavax
A single dose of 0.65 ml of Zostavax injection was given to each study subject
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Zostavax Receives: Biological: Zoster Vaccine, Live, (Oka-Merck) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
Measured: prevaccination and 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 posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionMay 2007
- Study completionMay 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Varicella Virus InfectionStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 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
- NCT00444860
- Sponsor's protocol ID
- V211-019
- Other IDs
- MKV211-019, 2007_008
- Status last verified
- Jun 2015
- First submitted
- 7 Mar 2007
- Last updated
- 4 Jun 2015
- Results posted
- No
Publications
Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.
PubMed 25681662
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 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 ZOSTAVAX(R) in Healthy Adults in Taiwan
- ClinicalTrials.gov ID
- NCT00444860
- Acronym / sponsor ID
- V211-019
- Conditions
- Varicella Virus Infection
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- May 2007 (actual)
- Study completion
- May 2007 (actual)
- First posted
- 8 Mar 2007 (estimated)
- Results
- Not posted in the source record
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 obtain safety and immunogenicity data for the refrigerator-stable formulation of ZOSTAVAX(R) in taiwanese adults.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Zoster Vaccine, Live, (Oka-Merck)Zostavax |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject Is Older Than 50 Years Of Age On Day Of Signing Informed Consent
- All Females Must Be Postmenopausal Or Have A Negative Serum Or Urine Pregnancy Test
- A Subject Who Is Of Reproductive Potential Must Agree To Remain Abstinent Or Use (Or Have Her Partner Use) 2 Acceptable Methods Of Birth Control For Three Months After Vaccination
- Subject Must Sign Informed Consent Prior To Any Study Procedure
- Subject Must Be afebrile (<38.3 °C Oral) On Day Of Vaccination
Key exclusion criteria (0 listed)
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, (Oka-Merck)Also: ZostavaxA single dose of 0.65 ml of Zostavax injection was given to each study subject | Biological | 1 |
Primary outcome
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed.
Time frame: prevaccination and 4 weeks postvaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2015.
- Results publication: PubMed 25681662Yao CA, Chen LK, Huang KC. The immunogenicity and safety of zoster vaccine in Taiwanese adults. Vaccine. 2015 Mar 24;33(13):1515-7. doi: 10.1016/j.vaccine.2015.01.085. Epub 2015 Feb 11.
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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, (Oka-Merck) in people with Varicella Virus Infection, 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 8 inclusion and 0 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 4 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The geometric mean fold rise (GMFR) of subjects VZV antibody titers from prevaccination to 4 weeks postvaccination, and the geometric mean titers (GMTs) at prevaccination and 4 weeks postvaccination, as measured by gpELISA, will be assessed. (time frame: prevaccination and 4 weeks 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 NCT00444860, 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 4 Jun 2015.