VaricellaNCT01077804
A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
An observational study of Varicella and Herpes Zoster, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Varicella, Herpes Zoster
- Type of treatment
- Vaccines
- How many people
- 7,585 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 1995to 1 Nov 2010
- Phase
- Observational
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: 15 years prospective follow-up of the original study cohort
Who may be able to join
- Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up
Who cannot join
- Subjects diagnosed with varicella before study enrollment
- Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
About this study
Official title: Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents
The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.
Read the detailed description
Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.
- Conditions
- Varicella, Herpes Zoster
- Medical subject headings
- Chickenpox, Herpes Zoster
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Varivax vaccinated children | Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Occurrence of Breakthrough Varicella
Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.
Measured: From 6 weeks to 168 months (14 years) post vaccination
Incidence Rate of Breakthrough Varicella
Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.
Measured: From 6 weeks to 168 months (14 years) post vaccination
Secondary outcomes (2)
Number of Participants With an Occurrence of Herpes Zoster Infection
Herpes zoster cases were physician-diagnosed cases.
Measured: From 6 weeks to 168 months (14 years) post vaccination
Incidence Rate of Herpes Zoster Infection
Herpes zoster cases were physician-diagnosed.
Measured: From 6 weeks to 168 months (14 years) post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study start1 Jun 1995
- Primary completion1 Sep 2010
- Study completion1 Nov 2010
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 VaricellaStudies 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
- 7,585 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Responsible party
- Sponsor
- Investigators
- Roger Baxter, Principal investigator, Kaiser Permanente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077804
- Sponsor's protocol ID
- V210-036
- Other IDs
- 2010_014, EP08005.002
- Status last verified
- Aug 2017
- First submitted
- 26 Feb 2010
- Last updated
- 15 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013 May;131(5):e1389-96. doi: 10.1542/peds.2012-3303. Epub 2013 Apr 1.
PubMed 23545380
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents
- ClinicalTrials.gov ID
- NCT01077804
- Acronym / sponsor ID
- V210-036
- Conditions
- Varicella, Herpes Zoster
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,585 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Collaborators
- Kaiser Permanente
- Study start
- 1 Jun 1995 (actual)
- Primary completion
- 1 Sep 2010 (actual)
- Study completion
- 1 Nov 2010 (actual)
- First posted
- 1 Mar 2010 (estimated)
- Results
- Posted 3 Nov 2011
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 these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.
Detailed description
Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Varivax vaccinated children | – | –Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months. |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 15 years prospective follow-up of the original study cohort
Key inclusion criteria (1 listed)
- Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up
Key exclusion criteria (2 listed)
- Subjects diagnosed with varicella before study enrollment
- Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants With an Occurrence of Breakthrough Varicella
Time frame: From 6 weeks to 168 months (14 years) post vaccination
Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.
Incidence Rate of Breakthrough Varicella
Time frame: From 6 weeks to 168 months (14 years) post vaccination
Parents/guardians of Varivax vaccinated children were interviewed every 6 months after vaccination. The number of participants with varicella (referred to as varicella with "any symptoms") were reported by parents during the interview. No medical confirmation of the diagnosis was required.
2 secondary outcomes
Number of Participants With an Occurrence of Herpes Zoster Infection
Time frame: From 6 weeks to 168 months (14 years) post vaccination
Incidence Rate of Herpes Zoster Infection
Time frame: From 6 weeks to 168 months (14 years) post vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23545380Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013 May;131(5):e1389-96. doi: 10.1542/peds.2012-3303. Epub 2013 Apr 1.
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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.
Roger Baxter principal investigator
Kaiser Permanente
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella and 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 2 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 15 Sep 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Nov 2011). 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?
Number of Participants With an Occurrence of Breakthrough Varicella (time frame: From 6 weeks to 168 months (14 years) post vaccination). 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 NCT01077804, 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 15 Sep 2017.