MeaslesPhase 3NCT00839917

A Study of ProQuad™ in Healthy Children in Korea (V221-023)

A Phase 3 study testing Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™) and M-M-R™ II and Varivax™ in people with Measles and Mumps, run by Merck Sharp & Dohme LLC.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will compare ProQuad™ and concomitant administration of M-M-R™ II and Varivax™ with respect to immunogenicity, safety and tolerability. The primary hypothesis to be tested is that the antibody response rates to measles, mumps, rubella, and varicella 6 weeks after vaccination with ProQuad™ will be… Read more about this study

Who is it for?: Ages 12 to 23 monthsHealthy volunteers can take part
Conditions the study is for: Measles, Mumps, Rubella
What is being tested?: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™) and M-M-R™ II and Varivax™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: Feb 2008to May 2008
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
Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Who cannot join

Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
Subject has a history of seizure disorder
Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
Subject has received an inactivated vaccine within the past 14 days
Subject has received a live vaccine within the past 30 days
Subject has received immune globulin within the past 5 months
Subject has a recent history of fever (within the last 72 hours)

About this study

Official title: A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™), M-M-R™ II and Varivax™
Keywords: Measles, Mumps, Rubella, Varicella
Medical subject headings: Measles, Mumps, Rubella, Chickenpox

What participants receive

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

Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)Biological
Also called V221
Single administration of 0.5 mL subcutaneous injection
M-M-R™ II and Varivax™Biological
Single administration of 0.5 mL subcutaneous injection

Study groups in NCT00839917
Study group	Role	What they receive
ProQuad™	Experimental	Not described Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
M-M-R™ II and Varivax™	Active comparator	Not described Receives: Biological: M-M-R™ II and Varivax™

What is being measured

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

Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Measured: 6 weeks postvaccination
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
Measured: 6 weeks postvaccination
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Measured: 6 weeks postvaccination
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline
Measured: 6 weeks postvaccination

Secondary outcomes (4)

Geometric Mean Titer of Measles Antibodies
Mean measles antibody response at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Measured: 6 weeks postvaccination
Geometric Mean Titer of Mumps Antibodies
Mean mumps antibody response at 6 weeks after vaccination for participants initially seronegative (<10 Units/mL) to mumps at baseline
Measured: 6 weeks postvaccination
Geometric Mean Titer of Rubella Antibodies
Mean rubella antibody response at 6 weeks postvaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Measured: 6 weeks postvaccination
Geometric Mean Titer of VZV (gpELISA) Antibodies
Mean VZV antibody response at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA Units/mL) to VZV at baseline
Measured: 6 weeks postvaccination

Timeline

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

Feb 2008May 2008

First posted10 Feb 2009 (estimated)
Study startFeb 2008
Primary completionMay 2008
Study completionMay 2008

Why it stopped: Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot

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 MeaslesStudies 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: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00839917
Sponsor's protocol ID: V221-023
Other IDs: 2009_538
Status last verified: Mar 2017
First submitted: 6 Feb 2009
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
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

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All Measles 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: A Multicenter, Randomized, Open-Label Study to Compare the Immunogenicity, Safety, and Tolerability of Measles, Mumps, Rubella, and Varicella of Combination Vaccine ProQuad With Concomitant Administration of M-M-R II and VARIVAX in Healthy Korean Children
ClinicalTrials.gov ID: NCT00839917
Acronym / sponsor ID: V221-023
Conditions: Measles, Mumps, Rubella, Varicella
Keywords: Measles, Mumps, Rubella, Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated early because of insufficient enrollment before expiration date of the investigational vaccine lot
Enrolment: 30 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: May 2008 (actual)
Study completion: May 2008 (actual)
First posted: 10 Feb 2009 (estimated)
Results: Posted 10 Oct 2012

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ProQuad™	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)
M-M-R™ II and Varivax™	Active comparator	Biological: M-M-R™ II and Varivax™

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
Subject has a negative clinical history for measles, mumps, rubella, varicella and zoster

Key exclusion criteria (8 listed)

Subject has previously received measles, mumps, rubella and/or varicella vaccine, either alone or in any combination
Subject has any congenital or acquired immune deficiency, neoplastic disease or depressed immunity
Subject has a history of seizure disorder
Subject had exposure to measles, mumps, rubella, varicella and/or zoster in the last 4 weeks
Subject has received an inactivated vaccine within the past 14 days

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
Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (ProQuad™)Also: V221Single administration of 0.5 mL subcutaneous injection	Biological	ProQuad™
M-M-R™ II and Varivax™Single administration of 0.5 mL subcutaneous injection	Biological	M-M-R™ II and Varivax™

Primary outcome

Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL
Time frame: 6 weeks postvaccination
Antibody response to measles at 6 weeks after vaccination for participants initially seronegative (<255 mIU/mL) to measles at baseline
Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL
Time frame: 6 weeks postvaccination
Antibody response to mumps at 6 weeks after vaccination for participants initially seronegative (<10 units/mL) to mumps at baseline
Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL
Time frame: 6 weeks postvaccination
Antibody response to rubella at 6 weeks after vaccination for participants initially seronegative (<10 IU/mL) to rubella at baseline
Percentage of Participants With Varicella-zoster Virus (VZV) Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
Time frame: 6 weeks postvaccination
Antibody response to VZV at 6 weeks after vaccination for participants initially seronegative (<5 gpELISA units/mL) to VZV at baseline

4 secondary outcomes

Geometric Mean Titer of Measles Antibodies
Time frame: 6 weeks postvaccination
Geometric Mean Titer of Mumps Antibodies
Time frame: 6 weeks postvaccination
Geometric Mean Titer of Rubella Antibodies
Time frame: 6 weeks postvaccination
Geometric Mean Titer of VZV (gpELISA) Antibodies
Time frame: 6 weeks postvaccination

Results and safety

Results posted to the registry on 10 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ProQuad™	13	12
M-M-R™ II and Varivax™	17	16

Primary outcome: Percentage of Participants With Measles Antibody Levels ≥255 mIU/mL

Time frame: 6 weeks postvaccination. Number (90% Confidence Interval). Unit: percentage of participants

Measure	ProQuad™ n = 10	M-M-R™ II and Varivax™ n = 8
Value	100.0 (74.1 to 100.0)	87.5 (52.9 to 99.4)

Population analysed: Analysis was performed on the per-protocol population, defined as all participants who had both pre- and post-vaccination blood samples, were seronegative at baseline, and followed all protocol procedures. Too few participants were enrolled in the study to perform non-inferiority analysis for this outcome measure.

Primary outcome: Percentage of Participants With Mumps Antibody Levels ≥10 Mumps Antibody Units/mL

Time frame: 6 weeks postvaccination. Number (90% Confidence Interval). Unit: percentage of participants

Measure	ProQuad™ n = 10	M-M-R™ II and Varivax™ n = 8
Value	100.0 (74.1 to 100.0)	100.0 (68.8 to 100.0)

Primary outcome: Percentage of Participants With Rubella Antibody Levels ≥10 IU/mL

Time frame: 6 weeks postvaccination. Number (90% Confidence Interval). Unit: percentage of participants

Measure	ProQuad™ n = 10	M-M-R™ II and Varivax™ n = 8
Value	100.0 (74.1 to 100.0)	100.0 (68.8 to 100.0)

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 postvaccination. Number (90% Confidence Interval). Unit: percentage of participants

Measure	ProQuad™ n = 10	M-M-R™ II and Varivax™ n = 8
Value	90.0 (60.6 to 99.5)	100.0 (68.8 to 100.0)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Through 28 days postvaccination. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ProQuad™	0 of 13 (0%)	8 of 13 (61.5%)	Not reported
M-M-R™ II and Varivax™	1 of 16 (6.3%)	9 of 16 (56.3%)	Not reported

Limitations and caveats (from the sponsor): Formal testing of the study hypotheses was not possible because of low enrollment

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

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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 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 8 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: stopped early, 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 10 Oct 2012). 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 Measles Antibody Levels ≥255 mIU/mL (time frame: 6 weeks postvaccination). The study lists 4 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 NCT00839917.

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.