MeaslesPhase 3NCT00402831

ProQuad® Intramuscular vs Subcutaneous

A Phase 3 study testing ProQuad® 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.

Trial summary

Primary objective: To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of… Read more about this study

Who is it for?: Ages 12 to 18 monthsHealthy volunteers can take part
Conditions the study is for: Measles, Mumps, Rubella
What is being tested?: ProQuad®
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 405 participants
Where: No sites listed yet
Study dates: 6 Oct 2006to 11 May 2007
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 18 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy participant of either gender,
Age 12 to 18 months,
Negative clinical history of measles, mumps, rubella, varicella and zoster,
Consent form signed by both holders of the parental authority or by the legal representative
Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Who cannot join

Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
Any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster
Any recent (≤3 days) history of febrile illness
Any severe chronic disease,
Active untreated tuberculosis,
Known personal history of seizure disorder,

Show all 12Show fewer

Any known blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems,
Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection,
Any immune impairment or humoral/cellular deficiency, neoplastic disease or depressed immunity including those resulting from corticosteroid [any long-term (≥14 days) administration of systemic corticosteroid therapy given daily or on alternate days at high doses (≥2 mg/kg/day prednisone equivalent or ≥20 mg/day if weight more than 10 kg) within the previous 30 days] or other immunosuppressive therapy,
Any previous (≤ 150 days) receipt of immune globulin or any blood-derived product or scheduled to be administered through Visit 3,
Any recent (≤7 days) tuberculin test or scheduled tuberculin test through Visit 3,
Any recent (≤30 days) receipt of an inactivated or a live vaccine or scheduled vaccination through Visit 3,

About this study

Official title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months

Primary objective:

To demonstrate that two doses of ProQuad® administered by IM route are as immunogenic as two doses of ProQuad® administered by SC route to healthy children 12 to 18 months of age in terms of antibody response rates to measles, mumps, rubella and to varicella at 42 days following the second dose of ProQuad®

Secondary objectives:

To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.

Conditions: Measles, Mumps, Rubella, Varicella
Being tested: ProQuad®
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.

ProQuad®Biological
Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.

Study groups in NCT00402831
Study group	Role	What they receive
Intramuscular ProQuad®	Experimental	Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm. Receives: Biological: ProQuad®
Subcutaneous ProQuad®	Active comparator	Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm. Receives: Biological: ProQuad®

What is being measured

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

Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Measured: Week 10 (6 weeks after Dose 2 on Week 4)

Secondary outcomes (12)

Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Antibody response rates were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using ELISA and varicella antibody levels were determined with gpELISA. Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.
Measured: Week 4
Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose
Antibody titre levels to measles were determined 4 weeks after the first dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.
Measured: Week 4
Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose
Antibody titre levels to mumps were determined 4 weeks after the first dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titres <10 ELISA Ab units mL.
Measured: Week 4
Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose
Antibody titre levels to rubella were determined 4 weeks after the first dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.
Measured: Week 4
Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose
Antibody titre levels to varicella were determined 4 weeks after the first dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.
Measured: Week 4
Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to measles were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles antibody levels were determined using ELISA. Titre levels were determined in participants with baseline measles titre <255 mIU/mL.
Measured: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to mumps were determined 6 weeks after the second dose of IM or SC ProQuad®. Mumps antibody levels were determined using ELISA. Titre levels were determined in participants with baseline mumps titre <10 ELISA Ab units mL.
Measured: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to rubella were determined 6 weeks after the second dose of IM or SC ProQuad®. Rubella antibody levels were determined using ELISA. Titre levels were determined in participants with baseline rubella titre <10 IU/mL.
Measured: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment
Antibody titre levels to varicella were determined 6 weeks after the second dose of IM or SC ProQuad®. Varicella antibody levels were determined with gpELISA. Titre levels were determined in participants with baseline varicella antibody titre <1.25 gpELISA units/mL.
Measured: Week 10 (6 weeks after Dose 2 on Week 4)
Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an investigational medicinal product (IMP) and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Measured: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP. Injection-site AEs (e.g., erythema, swelling, pain) and systemic vaccine-related AEs (e.g., pyrexia) were AEs of interest.
Measured: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose
An AE is any untoward medical occurrence in a participant administered an IMP and which does not necessarily have a causal relationship with the IMP.
Measured: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)

Timeline

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

6 Oct 200611 May 2007

First posted22 Nov 2006 (estimated)
Study start6 Oct 2006
Primary completion11 May 2007
Study completion11 May 2007

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: None (open label)
Enrolment: 405 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00402831
Sponsor's protocol ID: V221-036
Other IDs: F05-MMRV-304, 2006-001986-40
Status last verified: Aug 2018
First submitted: 21 Nov 2006
Last updated: 13 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

Publications

Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8.
PubMed 30481110

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 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Randomised, Comparative, Multicentre Study of the Immunogenicity and Safety of ProQuad® When Administered by Intramuscular (IM) Route or Subcutaneous (SC) Route to Healthy Children Aged 12 to 18 Months
ClinicalTrials.gov ID: NCT00402831
Acronym / sponsor ID: V221-036
Conditions: Measles, Mumps, Rubella, Varicella
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 405 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: 6 Oct 2006 (actual)
Primary completion: 11 May 2007 (actual)
Study completion: 11 May 2007 (actual)
First posted: 22 Nov 2006 (estimated)
Results: Posted 13 Aug 2018

Clinical summary

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

Primary objective:

Secondary objectives:

To describe the antibody response rates to measles, mumps, rubella and varicella measured 30 days following the first dose of ProQuad® administered by IM or SC route,
To describe the antibody titres to measles, mumps, rubella and varicella at 30 days following the first dose and at 42 days following the second dose of ProQuad® both administered by IM or SC route,
To describe the safety profile of two doses of ProQuad® both administered by IM or SC route.

Study design

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

Arm	Type	Receives
Intramuscular ProQuad®	Experimental	Biological: ProQuad®Participants will receive doses of ProQuad® by IM injection on Day 1 and Day 30 into the deltoid muscle perpendicular to the skin, with the first dose in the right arm and the second dose in the left arm.
Subcutaneous ProQuad®	Active comparator	Biological: ProQuad®Participants will receive doses of ProQuad® by SC injection on Day 1 and Day 30 in the deltoid area at a 45° angle to the skin, with the first dose in the right arm and second dose in the left arm.

Who may qualify

Ages: 12 to 18 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy participant of either gender,
Age 12 to 18 months,
Negative clinical history of measles, mumps, rubella, varicella and zoster,
Consent form signed by both holders of the parental authority or by the legal representative
Holder(s) of the the parental authority / legal representative able to understand the protocol requirements and to fill in the Diary Card.

Key exclusion criteria (12 listed)

Prior receipt of measles, mumps, rubella and/or varicella vaccine either alone or in any combination,
Any recent (≤30 days) exposure to measles, mumps, rubella, varicella and/or zoster
Any recent (≤3 days) history of febrile illness
Any severe chronic disease,
Active untreated tuberculosis,

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
ProQuad®Each dose (0.5 mL) contains live attenuated versions of measles virus Enders' Edmonston strain, mumps virus Jeryl Lynn™ (Level B) strain, rubella virus Wistar RA 27/3 strain, and varicella virus Oka/Merck strain.	Biological	Intramuscular ProQuad®, Subcutaneous ProQuad®

Primary outcome

Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody response rates were determined 6 weeks after the second dose of IM or SC ProQuad®. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA). Response rates were determined as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre <255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre <10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre <10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre <1.25 gpELISA units/mL.

12 secondary outcomes

Percentage of Participants Meeting Antibody Response Rate Criteria Four Weeks After the First ProQuad® Dose
Time frame: Week 4
Antibody Geometric Mean Titres (GMT) to Measles Four Weeks After the First ProQuad® Dose
Time frame: Week 4
Antibody GMT to Mumps Four Weeks After the First ProQuad® Dose
Time frame: Week 4
Antibody GMT to Rubella Four Weeks After the First ProQuad® Dose
Time frame: Week 4
Antibody GMT to Varicella Four Weeks After the First ProQuad® Dose
Time frame: Week 4
Antibody GMT to Measles Six Weeks After Completing ProQuad® Treatment
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Mumps Six Weeks After Completing ProQuad® Treatment
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Rubella Six Weeks After Completing ProQuad® Treatment
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Antibody GMT to Varicella Six Weeks After Completing ProQuad® Treatment
Time frame: Week 10 (6 weeks after Dose 2 on Week 4)
Percentage of Participants Experiencing an Injection-site Adverse Event (AE) or Vaccine-related Systemic AE After the First ProQuad® Dose
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)
Percentage of Participants Experiencing an Injection-site AE or Vaccine-related Systemic AE After the Second ProQuad® Dose
Time frame: From Day 30 up to Day 58 (up to 28 days after the second ProQuad® dose)
Percentage of Participants Discontinuing From Study Therapy Due to an AE After the First ProQuad® Dose
Time frame: From Day 0 up to Day 28 (up to 28 days after the first ProQuad® dose)

Results and safety

Results posted to the registry on 13 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intramuscular ProQuad®	202	201
Subcutaneous ProQuad®	203	200

Primary outcome: Percentage of Participants Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment

Time frame: Week 10 (6 weeks after Dose 2 on Week 4). Number (95% Confidence Interval). Unit: Percentage of participants

Measure	Intramuscular ProQuad® n = 153	Subcutaneous ProQuad® n = 148
Measles	100 (97.6 to 100)	100 (97.5 to 100)
Mumps	99.3 (96.4 to 100)	99.3 (96.3 to 100)
Rubella	100 (97.2 to 100)	99.2 (95.9 to 100)
Varicella	100 (97.4 to 100)	99.3 (95.9 to 100)

Intramuscular ProQuad® vs Subcutaneous ProQuad®: Mean Difference (Final Values): 0.0 (95% CI -2.5 to 2.6)
Intramuscular ProQuad® vs Subcutaneous ProQuad®: Mean Difference (Final Values): 0.1 (95% CI -3.0 to 3.3)
Intramuscular ProQuad® vs Subcutaneous ProQuad®: Mean Difference (Final Values): 0.7 (95% CI -2.3 to 4.1)

Population analysed: Participants who were initially seronegative to measles, mumps, rubella or varicella and who had post-vaccination serology results were included.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Day 72 (AEs were monitored for 28 days after each dose, and Dose 2 could have been given up to 44 days after Dose 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IM ProQuad® Arm: Dose 1	2 of 202 (1%)	153 of 202 (75.7%)	Not reported
SC ProQuad® Arm: Dose 1	2 of 203 (1%)	166 of 203 (81.8%)	Not reported
IM ProQuad® Arm: Dose 2	1 of 201 (0.5%)	141 of 201 (70.1%)	Not reported
SC ProQuad® Arm: Dose 2	1 of 200 (0.5%)	137 of 200 (68.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30481110Haas H, Richard P, Eymin C, Fiquet A, Kuter B, Soubeyrand B. Immunogenicity and safety of intramuscular versus subcutaneous administration of a combined measles, mumps, rubella, and varicella vaccine to children 12 to 18 months of age. Hum Vaccin Immunother. 2019;15(4):778-785. doi: 10.1080/21645515.2018.1549452. Epub 2019 Jan 8.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinicaltrials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.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.

Anne FIQUET, MD study director

SPMSD

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ProQuad® in people with Measles and Mumps, 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 5 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 13 Aug 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 13 Aug 2018). 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 Meeting Antibody Response Rate Criteria Six Weeks After Completing ProQuad® Treatment (time frame: Week 10 (6 weeks after Dose 2 on Week 4)). 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 NCT00402831, 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 13 Aug 2018.