VaricellaPhase 3NCT00822237

Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)

A Phase 3 study testing Varicella Virus Vaccine Live (2007 Process) (Oka/Merck), Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck) and Measles, Mumps, and Rubella Virus Vaccine Live (MMR) in people with Varicella, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children. 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?: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck), Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck) and Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 598 participants
Where: No sites listed yet
Study dates: Jan 2009to Dec 2009
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

Subject is in good health based on medical history
Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Who cannot join

Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
Subject has history of immune disorders
Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
Subject has received a live vaccine within 30 days of first dose of study vaccine
Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine
Subject has had a fever within 72 hours of study start

About this study

Official title: Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age

Read the detailed description

This treatment has been approved for sale to the public.

Conditions: Varicella
Being tested: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck), Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck), Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
Medical subject headings: Chickenpox

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)Biological
VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart
Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)Biological
VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart
Measles, Mumps, and Rubella Virus Vaccine Live (MMR)Biological
M-M-R II in two 0.5 mL doses by injection ~6 weeks apart

Study groups in NCT00822237
Study group	Role	What they receive
VARIVAX 2007 process + M-M-R II	Experimental	Not described Receives: Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck); Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
VARIVAX 1999 process + M-M-R II	Active comparator	Not described Receives: Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck); Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL.
Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
Measured: 6 weeks following first vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2009Dec 2009

First posted14 Jan 2009 (estimated)
Study startJan 2009
Primary completionOct 2009
Study completionDec 2009

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.
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, Investigator, Outcomes assessor
Enrolment: 598 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00822237
Sponsor's protocol ID: V210-057
Other IDs: 2009_510
Status last verified: Mar 2017
First submitted: 9 Jan 2009
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

All Varicella trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety, Tolerability, and Immunogenicity of VARIVAX (2007 Commercial VZV Bulk Process) Administered Concomitantly With M-M-R II in Healthy Children 12-to-23 Months of Age
ClinicalTrials.gov ID: NCT00822237
Acronym / sponsor ID: V210-057
Conditions: Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 598 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jan 2009
Primary completion: Oct 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 14 Jan 2009 (estimated)
Results: Posted 21 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This treatment has been approved for sale to the public.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
VARIVAX 2007 process + M-M-R II	Experimental	Biological: Varicella Virus Vaccine Live (2007 Process) (Oka/Merck), Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)
VARIVAX 1999 process + M-M-R II	Active comparator	Biological: Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck), Biological: Measles, Mumps, and Rubella Virus Vaccine Live (MMR)

Who may qualify

Ages: 12 to 23 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (2 listed)

Subject is in good health based on medical history
Subject has no history of measles, mumps, rubella, chickenpox, or shingles

Key exclusion criteria (7 listed)

Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination
Subject has history of immune disorders
Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start
Subject has received an inactivated vaccine within 14 days of first dose of study vaccine
Subject has received a live vaccine within 30 days of first dose of study vaccine

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
Varicella Virus Vaccine Live (2007 Process) (Oka/Merck)VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart	Biological	VARIVAX 2007 process + M-M-R II
Comparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart	Biological	VARIVAX 1999 process + M-M-R II
Measles, Mumps, and Rubella Virus Vaccine Live (MMR)M-M-R II in two 0.5 mL doses by injection ~6 weeks apart	Biological	VARIVAX 1999 process + M-M-R II, VARIVAX 2007 process + M-M-R II

Primary outcome

Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
Time frame: 6 weeks following first vaccination
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer < 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.

Results and safety

Results posted to the registry on 21 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
VARIVAX 2007 Process + M-M-R II	299	274
VARIVAX 1999 Process + M-M-R II	299	273

Primary outcome: Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).

Time frame: 6 weeks following first vaccination. Number. Unit: Percent of participants

Measure	VARIVAX 2007 Process + M-M-R II n = 246
Value	96.3

Population analysed: Per protocol population

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
VARIVAX 2007 Process + M-M-R II	1 of 296 (0.3%)	189 of 296 (63.9%)	Not reported
VARIVAX 1999 Process + M-M-R II	1 of 299 (0.3%)	156 of 299 (52.2%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Varicella

RecruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (ZFA01 Adjuvant, CHO Cells)
Herpes Zoster
Active, not recruitingPhase 2
A Phase 2 Study to Evaluate JCXH-105, an srRNA-based Herpes Zoster Vaccine
Herpes Zoster (HZ), Infectious Diseases
RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine

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?

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 2 inclusion and 7 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 12 Apr 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.

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 21 Apr 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?

Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). (time frame: 6 weeks following first vaccination). 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 NCT00822237.

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 12 Apr 2017.