MeaslesPhase 2NCT00986232

ProQuad Dose Selection Study (V221-011)(COMPLETED)

A Phase 2 study testing Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: M-M-R II and Comparator: PUVV in people with Measles and Mumps, 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

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Trial summary

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines. 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, Comparator: M-M-R II and Comparator: PUVV
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,551 participants
Where: No sites listed yet
Study dates: Apr 1999to Sep 2000
Phase: Phase 2
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

In good health
Negative clinical history of measles, mumps, rubella, varicella, and zoster

Who cannot join

Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
Any immune impairment or deficiency
Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
Vaccination with an inactive vaccine with in the past 14 days
Vaccination with a live vaccine within the past 30 days
Immune globulin or any blood product administered in the past 3 months

About this study

Official title: A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: M-M-R II, Comparator: PUVV
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 LiveBiological
Also called ProQuad
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
Comparator: M-M-R IIBiological
A single 0.5 mL subcutaneous injection at Day 0
Comparator: PUVVBiological
A single 0.5 mL subcutaneous injection at Day 0

Study groups in NCT00986232
Study group	Role	What they receive
1	Experimental	ProQuad (low dose) Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
2	Experimental	ProQuad (middle dose) Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
3	Experimental	ProQuad (high dose) Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
4	Active comparator	M-M-R II + PUVV Receives: Biological: Comparator: M-M-R II; Biological: Comparator: PUVV

What is being measured

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

Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units
Measured: 6 weeks postvaccination

Secondary outcomes (8)

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline
Measured: 6 weeks postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline
Measured: 6 weeks Postvaccination
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Measured: 6 weeks Postvaccination Visit 1 or Visit 2
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
Measured: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
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.

Apr 1999Sep 2000

First posted29 Sep 2009 (estimated)
Study startApr 1999
Primary completionApr 2000
Study completionSep 2000

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 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,551 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986232
Sponsor's protocol ID: V221-011
Other IDs: 2009_667
Status last verified: Mar 2015
First submitted: 25 Sep 2009
Last updated: 10 Apr 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.
PubMed 16094218

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 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections
ClinicalTrials.gov ID: NCT00986232
Acronym / sponsor ID: V221-011
Conditions: Measles, Mumps, Rubella, Varicella
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,551 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Apr 1999
Primary completion: Apr 2000 (actual)
Study completion: Sep 2000 (actual)
First posted: 29 Sep 2009 (estimated)
Results: Posted 15 Feb 2010

Clinical summary

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

A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad (low dose)
2	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad (middle dose)
3	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad (high dose)
4	Active comparator	Biological: Comparator: M-M-R II, Biological: Comparator: PUVVM-M-R II + PUVV

Who may qualify

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

Key inclusion criteria (2 listed)

In good health
Negative clinical history of measles, mumps, rubella, varicella, and zoster

Key exclusion criteria (6 listed)

Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination
Any immune impairment or deficiency
Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination
Vaccination with an inactive vaccine with in the past 14 days
Vaccination with a live vaccine within the past 30 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 LiveAlso: ProQuada single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90	Biological	1, 2, 3
Comparator: M-M-R IIA single 0.5 mL subcutaneous injection at Day 0	Biological	4
Comparator: PUVVA single 0.5 mL subcutaneous injection at Day 0	Biological	4

Primary outcome

Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
Time frame: 6 weeks postvaccination
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units

8 secondary outcomes

Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
Time frame: 6 weeks postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Time frame: 6 weeks Postvaccination
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Time frame: 6 weeks Postvaccination
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Time frame: 6 weeks Postvaccination Visit 1 or Visit 2
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
Time frame: 6 weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Time frame: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
Time frame: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
Time frame: 6 weeks postvaccination

Results and safety

Results posted to the registry on 15 Feb 2010, 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™ (Low Dose)	387	336
ProQuad™ (Middle Dose)	393	343
ProQuad™ (High Dose)	381	346
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)	390	370

Primary outcome: Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units

Time frame: 6 weeks postvaccination. Number. Unit: Participants

Measure	ProQuad™ (Low Dose) After 1 Injection n = 310	ProQuad™ (Low Dose) After 2 Injections n = 300	ProQuad™ (Middle Dose) After 1 Injection n = 313	ProQuad™ (Middle Dose) After 2 Injections n = 303	ProQuad™ (High Dose) After 1 Injection n = 307	ProQuad™ (High Dose) After 2 Injections n = 309	M-M-R™ II + PUVV After 1 Injection n = 320
Value	198	299	253	303	272	306	298

Population analysed: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Participants were followed for safety for 42 days after each scheduled vaccination.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ProQuad (Low Dose) After Injection 1	2 of 378 (0.5%)	286 of 378 (75.7%)	Not reported
ProQuad (Middle Dose) After Injection 1	3 of 387 (0.8%)	286 of 387 (73.9%)	Not reported
ProQuad (High Dose) After Injection 1	1 of 377 (0.3%)	289 of 377 (76.7%)	Not reported
M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)	1 of 381 (0.3%)	297 of 381 (78%)	Not reported
ProQuad (Low Dose) After Injection 2	1 of 353 (0.3%)	253 of 353 (71.7%)	Not reported
ProQuad (Middle Dose) After Injection 2	0 of 361 (0%)	258 of 361 (71.5%)	Not reported
ProQuad (High Dose) After Injection 2	2 of 358 (0.6%)	254 of 358 (70.9%)	Not reported

Limitations and caveats (from the sponsor): Seven (7) participants received unknown clinical material and 1 participant received diluent only; they were considered to be protocol violators and weren't included in the efficacy/safety analyses.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16094218Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schodel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children. Pediatr Infect Dis J. 2005 Aug;24(8):670-5. doi: 10.1097/01.inf.0000172901.29621.e9.

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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 6 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 10 Apr 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 15 Feb 2010). 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 Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units (time frame: 6 weeks postvaccination). 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 NCT00986232, 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 10 Apr 2015.