MeaslesPhase 3NCT00985153

Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)

A Phase 3 study testing Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Varivax and Comparator: M-M-R II 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

This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability. 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: Varivax and Comparator: 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: 3,927 participants
Where: No sites listed yet
Study dates: Mar 2000to May 2001
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

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

About this study

Official title: Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, Comparator: Varivax, Comparator: M-M-R II
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 at Day 0
Comparator: VarivaxBiological
A Single 0.5 mL subcutaneous injection at Day 0
Comparator: M-M-R IIBiological
A Single 0.5 mL subcutaneous injection at Day 0

Study groups in NCT00985153
Study group	Role	What they receive
1	Experimental	ProQuad Lot 1 Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
2	Experimental	ProQuad Lot 2 Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
3	Experimental	ProQuad Lot 3 Receives: Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live
4	Active comparator	M-M-R II + Varivax Receives: Biological: Comparator: Varivax; Biological: Comparator: M-M-R II

What is being measured

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

Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline
Measured: 6 weeks Postvaccination
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 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 for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline
Measured: 6 weeks Postvaccination
Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Measured: 6 weeks Postvaccination
Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Measles.
Measured: 6 weeks Postvaccination
Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Mumps.
Measured: 6 weeks Postvaccination
Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Measured: 6 weeks Postvaccination
Number of Participants With Serious Vaccine-related CAEs
Subjects 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

Timeline

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

Mar 2000May 2001

First posted28 Sep 2009 (estimated)
Study startMar 2000
Primary completionMay 2001
Study completionMay 2001

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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 3,927 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00985153
Sponsor's protocol ID: V221-012
Other IDs: 2009_669
Status last verified: Nov 2015
First submitted: 25 Sep 2009
Last updated: 23 Nov 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.
PubMed 16804432

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 23 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Safety, Tolerability, and Immunogenicity of 3 Consistency Lots of Frozen Measles, Mumps, Rubella, and Varicella Vaccine (ProQuad) in Healthy Children
ClinicalTrials.gov ID: NCT00985153
Acronym / sponsor ID: V221-012
Conditions: Measles, Mumps, Rubella, Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 3,927 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Mar 2000
Primary completion: May 2001 (actual)
Study completion: May 2001 (actual)
First posted: 28 Sep 2009 (estimated)
Results: Posted 9 Feb 2010

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: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad Lot 1
2	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad Lot 2
3	Experimental	Biological: Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine LiveProQuad Lot 3
4	Active comparator	Biological: Comparator: Varivax, Biological: Comparator: M-M-R IIM-M-R II + Varivax

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 (5 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 at Day 0	Biological	1, 2, 3
Comparator: VarivaxA Single 0.5 mL subcutaneous injection at Day 0	Biological	4
Comparator: M-M-R IIA Single 0.5 mL subcutaneous injection at Day 0	Biological	4

Primary outcome

Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA units/mL at Baseline
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 120 mIU/mL) to Measles at Baseline
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 Ab units/mL) to Mumps at Baseline
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Time frame: 6 weeks Postvaccination
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer < 10 IU/mL) to Rubella at Baseline
Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Measles.
Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Mumps.
Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer
Time frame: 6 weeks Postvaccination
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Number of Participants With Serious Vaccine-related CAEs
Time frame: 6 weeks Postvaccination
Subjects 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).

Results and safety

Results posted to the registry on 9 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™ Lot 1	985	950
ProQuad™ Lot 2	968	924
ProQuad™ Lot 3	962	918
M-M-R™ II + VARIVAX™	1,012	965

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

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

Measure	ProQuad™ Lot 1 n = 791	ProQuad™ Lot 2 n = 761	ProQuad™ Lot 3 n = 779	M-M-R™ II + VARIVAX™ n = 813
Value	726	718	736	772

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \<1.25 gpELISA units/mL at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL

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

Measure	ProQuad™ Lot 1 n = 802	ProQuad™ Lot 2 n = 771	ProQuad™ Lot 3 n = 779	M-M-R™ II + VARIVAX™ n = 811
Value	790	753	753	800

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL

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

Measure	ProQuad™ Lot 1 n = 856	ProQuad™ Lot 2 n = 823	ProQuad™ Lot 3 n = 830	M-M-R™ II + VARIVAX™ n = 872
Value	825	796	788	854

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.

Primary outcome: Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL

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

Measure	ProQuad™ Lot 1 n = 861	ProQuad™ Lot 2 n = 835	ProQuad™ Lot 3 n = 836	M-M-R™ II + VARIVAX™ n = 866
Value	852	821	828	859

Population analysed: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ProQuad™ Lot 1	6 of 969 (0.6%)	793 of 969 (81.8%)	Not reported
ProQuad™ Lot 2	8 of 950 (0.8%)	758 of 950 (79.8%)	Not reported
ProQuad™ Lot 3	11 of 941 (1.2%)	769 of 941 (81.7%)	Not reported
M-M-R™ II + VARIVAX™	11 of 993 (1.1%)	785 of 993 (79.1%)	Not reported

Limitations and caveats (from the sponsor): One additional subject received M-M-R™ II and ProQuad™ vaccines at the same visit in error; this child was excluded from all immunogenicity and safety summaries.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 16804432Lieberman JM, Williams WR, Miller JM, Black S, Shinefield H, Henderson F, Marchant CD, Werzberger A, Halperin S, Hartzel J, Klopfer S, Schodel F, Kuter BJ; Consistency Lot Study Group for ProQuad. The safety and immunogenicity of a quadrivalent measles, mumps, rubella and varicella vaccine in healthy children: a study of manufacturing consistency and persistence of antibody. Pediatr Infect Dis J. 2006 Jul;25(7):615-22. doi: 10.1097/01.inf.0000220209.35074.0b.

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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 5 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 23 Nov 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?

Yes. Results are posted in the registry (first posted 9 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 Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL (time frame: 6 weeks Postvaccination). The study lists 9 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 NCT00985153, 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 23 Nov 2015.