Herpes ZosterNCT01600079
ZOSTAVAX™ (Zoster Vaccine Live) Long-term Effectiveness Study (V211-024)
An observational study of Herpes Zoster and Shingles, run by Merck Sharp & Dohme LLC.
Trial summary
This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants. 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?
- ZOSTAVAX™
- Type of treatment
- Vaccines
- How many people
- 1,505,647 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2012to 16 Oct 2020
- Phase
- Observational
- 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
Study population: Members of Kaiser Permanente Northern California (KPNC)
Who may be able to join
- Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date
Who cannot join
None listed.
About this study
Official title: Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.
- Conditions
- Herpes Zoster, Shingles
- Being tested
- ZOSTAVAX™
- Keywords
- Varicella-zoster vaccine, herpes zoster, shingles, Varicella-zoster virus, postherpetic neuralgia, Herpesviridae Infections, DNA Virus Infections, Virus Diseases
- Medical subject headings
- Herpes Zoster, Chickenpox, Neuralgia, Postherpetic, Herpesviridae Infections, DNA Virus Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZOSTAVAX™Biological
Also called Zoster Vaccine Live
ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
| Study group | Role | What they receive |
|---|---|---|
| Vaccinated Cohort | Participants vaccinated with at least one dose of ZOSTAVAX™ Receives: Biological: ZOSTAVAX™ | |
| Unvaccinated Comparison Cohort | Participants who are not yet vaccinated with any zoster vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination
Measured: 10 years
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Measured: 10 years
Secondary outcomes (2)
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination
Measured: 10 years
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2012 (estimated)
- Study start15 May 2012
- Primary completion16 Oct 2020
- Study completion16 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,505,647 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600079
- Sponsor's protocol ID
- V211-024
- Other IDs
- 8003.016
- Status last verified
- Jul 2022
- First submitted
- 14 May 2012
- Last updated
- 14 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records. BMJ. 2023 Nov 8;383:e076321. doi: 10.1136/bmj-2023-076321.
PubMed 37940142Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention. Vaccine. 2019 Aug 23;37(36):5422-5427. doi: 10.1016/j.vaccine.2019.07.004. Epub 2019 Jul 10.
PubMed 31301920Baxter R, Bartlett J, Fireman B, Marks M, Hansen J, Lewis E, Aukes L, Chen Y, Klein NP, Saddier P. Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study. Am J Epidemiol. 2018 Jan 1;187(1):161-169. doi: 10.1093/aje/kwx245.
PubMed 29309521
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Licensure Observational Study of the Long-term Effectiveness of ZOSTAVAX™
- ClinicalTrials.gov ID
- NCT01600079
- Acronym / sponsor ID
- V211-024
- Conditions
- Herpes Zoster, Shingles
- Keywords
- Varicella-zoster vaccine, herpes zoster, shingles, Varicella-zoster virus, postherpetic neuralgia, Herpesviridae Infections, DNA Virus Infections, Virus Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,505,647 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 15 May 2012 (actual)
- Primary completion
- 16 Oct 2020 (actual)
- Study completion
- 16 Oct 2020 (actual)
- First posted
- 16 May 2012 (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.
This study will describe the impact of vaccination with ZOSTAVAX™ on the epidemiology of herpes zoster (HZ) in a cohort of vaccinated participants 50 years or age or older, compared to a cohort of unvaccinated participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccinated Cohort | – | Biological: ZOSTAVAX™Participants vaccinated with at least one dose of ZOSTAVAX™ |
| Unvaccinated Comparison Cohort | – | –Participants who are not yet vaccinated with any zoster vaccine |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Members of Kaiser Permanente Northern California (KPNC)
Key inclusion criteria (1 listed)
- Participants with continuous Kaiser Permanente Northern California (KPNC) membership since becoming age-eligible for ZOSTAVAX™ and with 12 months of continuous enrollment in KPNC before their study start date
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 |
|---|---|---|
| ZOSTAVAX™Also: Zoster Vaccine LiveZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use | Biological | Vaccinated Cohort |
Primary outcome
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination
Time frame: 10 years
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Time frame: 10 years
2 secondary outcomes
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79, ≥80) at Vaccination
Time frame: 10 years
Incidence of Postherpetic Neuralgia in Vaccinated and Unvaccinated Cohorts by Time since Vaccination
Time frame: 10 years
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 14 Jul 2022.
- Derived from this study: PubMed 37940142Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Effectiveness of the live zoster vaccine during the 10 years following vaccination: real world cohort study using electronic health records. BMJ. 2023 Nov 8;383:e076321. doi: 10.1136/bmj-2023-076321.
- Derived from this study: PubMed 31301920Klein NP, Bartlett J, Fireman B, Marks MA, Hansen J, Lewis E, Aukes L, Saddier P. Long-term effectiveness of zoster vaccine live for postherpetic neuralgia prevention. Vaccine. 2019 Aug 23;37(36):5422-5427. doi: 10.1016/j.vaccine.2019.07.004. Epub 2019 Jul 10.
- Derived from this study: PubMed 29309521Baxter R, Bartlett J, Fireman B, Marks M, Hansen J, Lewis E, Aukes L, Chen Y, Klein NP, Saddier P. Long-Term Effectiveness of the Live Zoster Vaccine in Preventing Shingles: A Cohort Study. Am J Epidemiol. 2018 Jan 1;187(1):161-169. doi: 10.1093/aje/kwx245.
- Individual participant dataSharing planned: No
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 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 14 Jul 2022. 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.
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?
Incidence of Herpes Zoster in Vaccinated and Unvaccinated Cohorts, Overall, and by Age (50-59, 60-69, 70-79 ≥80) at Vaccination (time frame: 10 years). The study lists 2 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 NCT01600079, which also lists 3 linked publications.
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 14 Jul 2022.