VaricellaPhase 3NCT01626794
A Study to Evaluate the Immunogenicity, Safety, and Tolerability of VARIVAX™ Manufactured With a New Process (V210-062)
A Phase 3 study testing VARIVAX™ VEP, VARIVAX™ 2007 Process and M-M-R™ II in people with Varicella, run by Merck Sharp & Dohme LLC.
Trial summary
This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those… Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Varicella
- What is being tested?
- VARIVAX™ VEP, VARIVAX™ 2007 Process and M-M-R™ II
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Oct 2015
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- negative clinical history of measles, mumps, rubella, varicella, and zoster
Who cannot join
- received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study
- history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
- received salicylates within 14 days prior to study vaccination
- exposed to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to study vaccination
Show all 12Show fewer
- received any non-live vaccine within 14 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
- received any live vaccine within 30 days prior to any study vaccination or is expected to received such vaccine during the 42-day period after each study vaccination
- received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to any study vaccination
- fever illness (≥102.2°F [39.0°C]) within 72 hours prior to study vaccination
- born to a human immunodeficiency virus (HIV)-infected mother
- participated in any other clinical trial (other than a surveillance study) within 30 days prior to study enrollment
About this study
Official title: A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)
This study will test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.
- Conditions
- Varicella
- Being tested
- VARIVAX™ VEP, VARIVAX™ 2007 Process, M-M-R™ II
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VARIVAX™ VEPBiological
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
VARIVAX™ 2007 ProcessBiological
Two 0.5 mL subcutaneous doses administered on Days 1 and 91
M-M-R™ IIBiological
Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
| Study group | Role | What they receive |
|---|---|---|
| VARIVAX™ VEP | Experimental | Not described Receives: Biological: VARIVAX™ VEP; Biological: M-M-R™ II |
| VARIVAX™ 2007 Process | Active comparator | Not described Receives: Biological: VARIVAX™ 2007 Process; Biological: M-M-R™ II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
Measured: Six weeks (43 days) after vaccination 1
Secondary outcomes (3)
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
Measured: Days 1 to 42 after each vaccination
Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms
Measured: Days 1 to 42 after each vaccination
Percent of participants with injection-site reactions
Measured: Days 1 to 5 after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startJul 2014
- Primary completionOct 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 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
- NCT01626794
- Sponsor's protocol ID
- V210-062
- Status last verified
- Jan 2015
- First submitted
- 8 Jun 2012
- Last updated
- 27 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Double Blind, Randomized, Multicenter, Controlled Study to Evaluate the Immunogenicity, Safety and Tolerability of VARIVAX Made With the Varicella Enhanced Process (VEP)
- ClinicalTrials.gov ID
- NCT01626794
- Acronym / sponsor ID
- V210-062
- Conditions
- Varicella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 25 Jun 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 test the immunogenicity, safety, and tolerability of VARIVAX™ manufactured with the Varicella Enhanced Process (VEP) compared with the VARIVAX™ 2007 Process. The primary hypotheses being tested are 1)VARIVAX™ VEP will induce varicella-zoster virus (VZV) antibody responses that are non-inferior to those induced by VARIVAX™ 2007 process at 6 weeks after vaccination 1, and 2) VARIVAX™ VEP will induce an acceptable anti-VZV antibody response rate at 6 weeks after vaccination 1.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VARIVAX™ VEP | Experimental | Biological: VARIVAX™ VEP, Biological: M-M-R™ II |
| VARIVAX™ 2007 Process | Active comparator | Biological: VARIVAX™ 2007 Process, Biological: M-M-R™ II |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- negative clinical history of measles, mumps, rubella, varicella, and zoster
Key exclusion criteria (12 listed)
- received any measles, mumps, rubella, or varicella vaccine at any time prior to the study, or is anticipated to receive any of these vaccines outside the study
- any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity
- received systemic immunomodulatory steroids within 3 months prior to entering the study or is expected to require them throughout the study
- history of allergy or anaphylactoid reaction to neomycin, gelatin, sorbital, egg proteins, chicken proteins, or any components of M-M-R™ II or VARIVAX™
- received salicylates within 14 days prior to study vaccination
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 |
|---|---|---|
| VARIVAX™ VEPTwo 0.5 mL subcutaneous doses administered on Days 1 and 91 | Biological | VARIVAX™ VEP |
| VARIVAX™ 2007 ProcessTwo 0.5 mL subcutaneous doses administered on Days 1 and 91 | Biological | VARIVAX™ 2007 Process |
| M-M-R™ IITwo doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process | Biological | VARIVAX™ 2007 Process, VARIVAX™ VEP |
Primary outcome
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL
Time frame: Six weeks (43 days) after vaccination 1
3 secondary outcomes
Percent of participants with fever (≥102.2°F [39.0°C] oral equivalent)
Time frame: Days 1 to 42 after each vaccination
Percent of participants with measles-like, rubella-like, varicella-like, or zoster-like rash and mumps-like symptoms
Time frame: Days 1 to 42 after each vaccination
Percent of participants with injection-site reactions
Time frame: Days 1 to 5 after each vaccination
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2015.
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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 3 study testing VARIVAX™ VEP, VARIVAX™ 2007 Process and M-M-R™ II in people with Varicella, 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 12 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: withdrawn, as of the sponsor's last update on 27 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Percent of Participants with VZV antibody levels ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL (time frame: Six weeks (43 days) after vaccination 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Jan 2015.