VaricellaPhase 3NCT02062502
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
A Phase 3 study testing VARIVAX™ New Seed Process, VARIVAX™ 2007 process and M-M-R II™ in people with Varicella, run by Merck Sharp & Dohme LLC.
Trial summary
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. 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™ New Seed Process, VARIVAX™ 2007 process and M-M-R II™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 611 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2014to 13 Oct 2015
- 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 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella
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 receive them during the course of the study
- History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
- Received salicylates within 14 days prior to study vaccination
- Exposed to varicella, herpes zoster, measles, mumps, or rubella in the 4 weeks prior to study vaccination
Show all 12Show fewer
- Received immune globulin, a blood transfusion, or blood-derived products within 5 months prior to study vaccination
- History of seizure disorder, including febrile seizure
- Fever illness (>=102.2 °F [39.0 °C] within 72 hours prior to study vaccination
- History of thrombocytopenia
- 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™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II
This study will evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
- Conditions
- Varicella
- Being tested
- VARIVAX™ New Seed Process, 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™ New Seed ProcessBiological
Varicella virus vaccine live manufactured with a new seed process
VARIVAX™ 2007 processBiological
Varicella virus vaccine live manufactured with the 2007 process
M-M-R II™Biological
Measles, Mumps, and Rubella virus vaccine live
| Study group | Role | What they receive |
|---|---|---|
| VARIVAX™ NSP + M-M-R II™ | Experimental | VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 Receives: Biological: VARIVAX™ New Seed Process; Biological: M-M-R II™ |
| VARIVAX™ 2007 Process + M-M-R II™ | Active comparator | VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 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.
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Measured: 6 weeks (43 days) after vaccination 1
Geometric Mean Titer of VZV Antibodies
Antibody titers were measured with gpELISA.
Measured: 6 weeks (43 days) after vaccination 1
Secondary outcomes (5)
Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Measured: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Measured: Up to 42 days after Vaccination 1
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Measured: Up to 42 days after Vaccination 2
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Measured: Up to 5 days after Vaccination 1
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Measured: Up to 5 days after Vaccination 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2014 (estimated)
- Study start7 Mar 2014
- Primary completion24 Feb 2015
- Study completion13 Oct 2015
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 611 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02062502
- Sponsor's protocol ID
- V210-063
- Status last verified
- Oct 2018
- First submitted
- 12 Feb 2014
- Last updated
- 30 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
Publications
Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.
PubMed 29087781
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. 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™ New Seed Process (NSP) Administered Concomitantly With M-M-R™ II
- ClinicalTrials.gov ID
- NCT02062502
- Acronym / sponsor ID
- V210-063
- Conditions
- Varicella
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 611 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 7 Mar 2014 (actual)
- Primary completion
- 24 Feb 2015 (actual)
- Study completion
- 13 Oct 2015 (actual)
- First posted
- 13 Feb 2014 (estimated)
- Results
- Posted 1 Mar 2016
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 evaluate the immunogenicity, safety, and tolerability of VARIVAX™ (Varicella Virus Vaccine Live) manufactured with a New Seed Process (NSP) compared with the VARIVAX™ 2007 process. The primary hypotheses being tested are that antibody response rate and mean antibody titer induced at 6 weeks after a single vaccination by VARIVAX™ NSP are non-inferior to those induced by VARIVAX™ 2007 process, and that antibody response rate induced by VARIVAX™ NSP is acceptable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VARIVAX™ NSP + M-M-R II™ | Experimental | Biological: VARIVAX™ New Seed Process, Biological: M-M-R II™VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
| VARIVAX™ 2007 Process + M-M-R II™ | Active comparator | Biological: VARIVAX™ 2007 process, Biological: M-M-R II™VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91 |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Negative clinical history for varicella, herpes zoster, measles, mumps, and rubella
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 receive them during the course of the study
- History of allergy or anaphylactic reaction to neomycin, gelatin, sorbitol, egg proteins, chicken proteins, or any component of VARIVAX™ or M-M-R II™
- 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™ New Seed ProcessVaricella virus vaccine live manufactured with a new seed process | Biological | VARIVAX™ NSP + M-M-R II™ |
| VARIVAX™ 2007 processVaricella virus vaccine live manufactured with the 2007 process | Biological | VARIVAX™ 2007 Process + M-M-R II™ |
| M-M-R II™Measles, Mumps, and Rubella virus vaccine live | Biological | VARIVAX™ 2007 Process + M-M-R II™, VARIVAX™ NSP + M-M-R II™ |
Primary outcome
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Time frame: 6 weeks (43 days) after vaccination 1
Geometric Mean Titer of VZV Antibodies
Time frame: 6 weeks (43 days) after vaccination 1
Antibody titers were measured with gpELISA.
5 secondary outcomes
Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Time frame: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Time frame: Up to 42 days after Vaccination 1
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Time frame: Up to 42 days after Vaccination 2
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Time frame: Up to 5 days after Vaccination 1
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Time frame: Up to 5 days after Vaccination 2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29087781Senders SD, Bundick ND, Li J, Zecca C, Helmond FA. Evaluation of immunogenicity and safety of VARIVAX New Seed Process (NSP) in children. Hum Vaccin Immunother. 2018 Feb 1;14(2):442-449. doi: 10.1080/21645515.2017.1388479. Epub 2017 Dec 11.
- Individual participant dataSharing planned: Yes. https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf
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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?
A Phase 3 study testing VARIVAX™ New Seed Process, 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: finished, as of the sponsor's last update on 30 Oct 2018. 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 1 Mar 2016). 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?
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL (time frame: 6 weeks (43 days) after vaccination 1). 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 NCT02062502, 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 30 Oct 2018.