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MeaslesPhase 3NCT00560755

Safety Study of ProQuad® rHA in Infants (V221-037)

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.

Official record
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Trial summary

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life. Read more about this study

Who is it for?
Ages 12 to 22 monthsHealthy volunteers can take part
Conditions the study is for
Measles, Mumps, Rubella
What is being tested?
ProQuad®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,388 participants
Where
No sites listed yet
Study dates
24 Oct 2007to 24 Nov 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 22 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Healthy subject of either gender,
  • Age from 12 to 22 months,
  • Negative clinical history of infection with measles, mumps, rubella, varicella or zoster,
  • Informed consent form signed by the parent(s) or by legal representative
  • Parent(s) or legal representative able to attend all schedule visits with the subject and to understand and comply with the study procedures

Who cannot join

  • Recent (≤ 3 days) history of febrile illness
  • Prior receipt of measles, mumps, rubella and/or varicella vaccination, either alone or in any combination
  • Recent (≤ 30 days) exposure to measles, mumps, rubella, varicella or zoster
  • Prior known sensitivity/allergy to any component of the vaccine
  • Severe chronic disease,
  • Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic system
Show all 19Show fewer
  • Any severe thrombocytopenia or any other coagulation disorder that would contraindicate intramuscular injection
  • Humoral or cellular immunodeficiency,
  • Current immunosuppressive therapy
  • Family history of congenital or hereditary immunodeficiency
  • Hereditary problems of fructose intolerance
  • Known personal history of encephalopathy, seizure disorder or progressive, evolving or unstable neurological condition,
  • Known active tuberculosis
  • Recent (≤ 2 days) tuberculin test or scheduled tuberculin test through Visit 3
  • Receipt of immunoglobulins or blood-derived products in the past 150 days
  • Receipt of an inactivated vaccine in the past 14 days
  • Receipt of a live vaccine in the past 28 days
  • Any medical condition which, in the opinion of the investigator, might interfere with the evaluation of study objectives
  • Participation in another clinical study in the past 30 days

About this study

Official title: An Open-label, Multi-centre Study of the Safety of a 2-dose Regimen of a Combined Measles, Mumps, Rubella and Varicella Live Vaccine (ProQuad®) Manufactured With Recombinant Human Albumin (rHA) When Administered to Children in Their Second Year of Life

Primary objective: To describe the safety profile of a second dose of ProQuad® manufactured with recombinant human albumin (rHA) when administered to children in their second year of life.

Secondary objectives: To describe the safety profile of a first dose of ProQuad® manufactured with rHA when administered to children in their second year of life.

Being tested
ProQuad®
Keywords
Prevention of: measles, mumps, rubella and 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.

  • ProQuad®Biological

    ProQuad® manufactured with recombinant human albumin (rHA) is an investigational combined attenuated live virus vaccine for vaccination against measles, mumps, rubella and varicella viruses.

Study groups in NCT00560755
Study groupRoleWhat they receive
ProQuad®ExperimentalHealthy infants (12 to 22 months of age) received 2 doses of ProQuad® (Dose 1 on Day 1 and Dose 2 on Day 28 to 42) via subcutaneous injection into the deltoid muscle.
Receives: Biological: ProQuad®

What is being measured

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

  1. Percentage of Participants Experiencing an Adverse Event (AE) After ProQuad® Dose 2

    The percentage of participants experiencing an AE(s) for up to 28 days after the second ProQuad® injection was determined.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  2. Percentage of Participants Experiencing a Vaccine-related AE After ProQuad® Dose 2

    The percentage of participants experiencing a vaccine-related AEs for up to 28 days after the second ProQuad® injection was determined.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  3. Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 2

    The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 2.

    Measured: Up to Day 46 (for 4 days following ProQuad® Dose 2)

  4. Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 2

    The percentage of participants experiencing a unsolicited injection-site AE(s) were monitored for up to 28 days after the second ProQuad® injection.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  5. Percentage of Participants Experiencing a Injection-site Rash of Interest AE After ProQuad® Dose 2

    Injection-site rashes of interest, including measles-like, rubella-like, and vesicular, were monitored for up to 28 days after the second ProQuad® injection.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  6. Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 2

    Systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  7. Percentage of Participants Experiencing a Vaccine-related Systemic AE After ProQuad® Dose 2

    Vaccine-related systemic AEs were monitored for up to 28 days after the second ProQuad® injection.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  8. Percentage of Participants Experiencing a Non-injection-site Rash of Interest AE After ProQuad® Dose 2

    Non-injection-site rashes of interest, including measles-like, rubella-like, varicella-like, and zoster-like rashes, were monitored for up to 28 days after the second ProQuad® injection.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  9. Percentage of Participants Experiencing a Mumps-like Illness After ProQuad® Dose 2

    The percentage of participants experiencing a mumps-like illness for up to 28 days after the second ProQuad® injection was determined.

    Measured: Up to Day 70 (up to 28 days after ProQuad® Dose 2)

  10. Percentage of Participants Experiencing a Serious AE (SAE) After ProQuad® Dose 2

    Serious AEs ere defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.

    Measured: Up to Day 84 (up to 42 days after ProQuad® Dose 2)

  11. Percentage of Participants Experiencing a Vaccine-related SAE After ProQuad® Dose 2

    Vaccine-related SAEs were defined as any untoward consequence that results in death, is life-threatening, requires hospitalization or prolongs existing hospitalization, is a congenital anomaly/birth defect, or is any other medically important event.

    Measured: Up to Day 84 (up to 42 days after ProQuad® Dose 2)

Secondary outcomes (4)

  1. Percentage of Participants Experiencing a Solicited Injection-site AE After ProQuad® Dose 1

    The solicited injection-site AEs erythema, swelling, and pain were monitored for 4 days after administration of ProQuad® Dose 1.

    Measured: From Day 1 to Day 4 (for 4 days following ProQuad® Dose 1)

  2. Percentage of Participants Experiencing a Unsolicited Injection-site AE After ProQuad® Dose 1

    Unsolicited injection-site AEs were monitored for up to 28 days after the first ProQuad® injection.

    Measured: Up to Day 28 (28 days after ProQuad® Dose 1)

  3. Percentage of Participants With ≥ 1 Rectal Temperature Reading ≥ 38.0° C After ProQuad® Dose 1

    The percentage of participants with at least 1 rectal temperature reading ≥ 38.0° C was determined.

    Measured: Up to Day 28 (28 days after ProQuad® Dose 1)

  4. Percentage of Participants Experiencing a Systemic AE After ProQuad® Dose 1

    Systemic AEs were monitored for up to 28 days after the first ProQuad® injection.

    Measured: Up to Day 28 (28 days after ProQuad® Dose 1)

Timeline

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

  1. First posted20 Nov 2007 (estimated)
  2. Study start24 Oct 2007
  3. Primary completion24 Nov 2008
  4. Study completion24 Nov 2008

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,388 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00560755
Sponsor's protocol ID
V221-037
Other IDs
MRV01C, 2007-002438-12
Status last verified
Sep 2017
First submitted
19 Nov 2007
Last updated
17 Oct 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Ruger G, Gabutti G, Rumke H, Rombo L, Bernaola E, Diez-Domingo J, Martinon-Torres F, Hogh B, Konstantopoulos A, Fiquet A, Thomas S, Eymin C, Baudin M. Safety of a 2-dose regimen of a combined measles, mumps, rubella and varicella live vaccine manufactured with recombinant human albumin. Pediatr Infect Dis J. 2012 Nov;31(11):1166-72. doi: 10.1097/INF.0b013e318267fd8b.

    PubMed 22772170

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 19 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 17 Oct 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 17 Oct 2017). 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 Experiencing an Adverse Event (AE) After ProQuad® Dose 2 (time frame: Up to Day 70 (up to 28 days after ProQuad® Dose 2)). The study lists 11 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 NCT00560755, 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 17 Oct 2017.

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