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AzTrials

MeaslesPhase 3NCT01536405

Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)

A Phase 3 study testing MMRV (AMP) and MMRV (2006 process) 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 the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process 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?
MMRV (AMP) and MMRV (2006 process)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,412 participants
Where
No sites listed yet
Study dates
5 Jun 2012to 27 Jan 2014
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

  • Negative clinical history for measles, mumps, rubella, varicella, and zoster

Who cannot join

  • Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
  • Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
  • Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
  • Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
  • Received 1) systemic immunomodulatory steroids [greater than the
  • equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to
Show all 16Show fewer
  • entering the study, or 2) any dose of systemic immunomodulatory steroids within
  • 7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
  • History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
  • Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
  • Diagnosis of an active neurological disorder. Enrollment may be considered
  • when the disease process has been stabilized
  • History of seizure disorder, including single febrile seizure
  • Diagnosis of active untreated tuberculosis
  • History of thrombocytopenia
  • Born to a human immunodeficiency virus (HIV) infected mother

About this study

Official title: A Phase III Double-Blind, Randomized, Multicenter, Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)

This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process

Being tested
MMRV (AMP), MMRV (2006 process)
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.

  • MMRV (AMP)Biological

    Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

  • MMRV (2006 process)Biological

    Also called ProQuad™

    Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.

Study groups in NCT01536405
Study groupRoleWhat they receive
MMRV (AMP)ExperimentalParticipants received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
Receives: Biological: MMRV (AMP)
MMRV (2006 process)Active comparatorParticipants received two 0.5 mL subcutaneous injections of MMRV vaccine made with the 2006 manufacturing process
Receives: Biological: MMRV (2006 process)

What is being measured

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

  1. Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL

    Sera were tested for VZV Immunoglobulin (IgG) antibody levels by a glycoprotein enzyme-linked immunosorbent assay (gpELISA)

    Measured: Six weeks after vaccination 1

  2. Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL

    Sera were tested for measles virus IgG antibody levels by an ELISA

    Measured: Six weeks after vaccination 1

  3. Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL

    Sera were tested for mumps virus IgG antibody levels by an enzyme-linked immunosorbent assay (ELISA)

    Measured: Six weeks after vaccination 1

  4. Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL)

    Sera were tested for rubella virus IgG antibody levels by an ELISA

    Measured: Six weeks after vaccination 1

  5. Geometric Mean Titer (GMT) of VZV Antibodies

    Sera were tested for VZV IgG antibody levels by gpELISA

    Measured: Six weeks after vaccination 1

  6. Geometric Mean Titer (GMT) of Measles Virus Antibodies

    Sera were tested for measles virus IgG antibody levels by ELISA

    Measured: Six weeks after vaccination 1

  7. Geometric Mean Titer (GMT) of Mumps Virus Antibodies

    Sera were tested for mumps virus IgG antibody levels by ELISA

    Measured: Six weeks after vaccination 1

  8. Geometric Mean Titer (GMT) of Rubella Virus Antibodies

    Sera were tested for rubella virus IgG antibody levels by ELISA

    Measured: Six weeks after vaccination 1

  9. Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

    Measured: Up to 5 days after vaccination 1

Secondary outcomes (7)

  1. Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent)

    Measured: Up to 42 days after each vaccination

  2. Percentage of Participants With Zoster-like Rash

    Measured: Up to 42 days after each vaccination

  3. Percentage of Participants With Mumps-like Symptoms

    Measured: Up to 42 days after each vaccination

  4. Percentage of Participants With Measles-like Rash

    Measured: Up to 42 days after each vaccination

  5. Percentage of Participants With Rubella-like Rash

    Measured: Up to 42 days after each vaccination

  6. Percentage of Participants With Varicella-like Rash

    Measured: Up to 42 days after each vaccination

  7. Percentage of Participants With an Injection-site Adverse Event

    An adverse event (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study vaccine, whether or not considered related to the use of the product. Any worsening of a preexisting condition which is temporally associated with the use of the study vaccine is also an AE. Injection-site AEs reported were solicited with a Vaccine Report Card.

    Measured: Up to 5 days after each vaccination

Timeline

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

  1. First posted22 Feb 2012 (estimated)
  2. Study start5 Jun 2012
  3. Primary completion2 Jul 2013
  4. Study completion27 Jan 2014

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,412 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01536405
Sponsor's protocol ID
V221-027
Other IDs
P20930
Status last verified
Oct 2018
First submitted
16 Feb 2012
Last updated
31 Oct 2018
Data monitoring committee
No
Individual data sharing
Yes: https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Marshall GS, Senders SD, Shepard J, Twiggs JD, Gardner J, Hille D, Hartzel J, Valenzuela R, Stek JE, Helmond FA. A double blind, randomized, active controlled study to assess the safety, tolerability and immunogenicity of measles, mumps rubella, and varicella vaccine (MMRV) manufactured using an alternative process. Hum Vaccin Immunother. 2016 Aug 2;12(8):2188-2196. doi: 10.1080/21645515.2016.1165374. Epub 2016 May 5.

    PubMed 27149048

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MMRV (AMP) and MMRV (2006 process) 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 1 inclusion and 16 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 31 Oct 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 2 Jul 2014). 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 Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL (time frame: Six weeks after vaccination 1). 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 NCT01536405, 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 31 Oct 2018.

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