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RubellaPhase 3NCT02058563

Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

A Phase 3 study testing Priorix® and Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine in people with Rubella and Mumps, run by GlaxoSmithKline at 17 sites in 3 countries.

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

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US. Read more about this study

Who is it for?
Ages 7 years and olderHealthy volunteers can take part
Conditions the study is for
Rubella, Mumps, Measles
What is being tested?
Priorix® and Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
996 participants
Where
17 sitesin 3 countries
Study dates
1 Jul 2014to 17 Sep 2015
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 7 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Subjects who the investigator believes that they and/or their parent(s) or Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol.
  • Male or female subjects 7 years of age or older and born after December 31, 1956*. *The only exception to this is health care workers born before 1957 without other evidence of immunity to mumps for which one dose of a live mumps virus vaccine is recommended; therefore this population is eligible for enrollment in this study.
  • For all children 7-17 years of age:
  • Written documentation of prior receipt of 1 dose of MMR vaccine administered on or after the first birthday.
  • For all adults 18 years of age and older:
  • Prior receipt (written or verbal history) of at least one dose of MMR vaccine.
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  • Birth in the US.
  • Written informed consent obtained from the subject or from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects who are still legally minors in line with local rules and regulations).
  • Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
  • Female subjects of non-childbearing potential may be enrolled in the study.
  • Non-childbearing potential is defined as pre-menarche, current tubal ligation, hysterectomy, or ovariectomy or post-menopause.
  • Female subjects of childbearing potential may be enrolled in the study, if the subject
  • Has agreed to be abstinent or practiced adequate contraception during the entire period starting 30 days prior to vaccination(s) until 3 months after receipt of the study vaccination and
  • has a negative pregnancy test on the day of vaccination.

Who cannot join

  • Child in care.
  • For all children 7-17 years of age:
  • Previous receipt of more than 1 dose of a measles-containing vaccine.
  • Use of any investigational or non-registered product other than the study vaccine(s), during the period starting 30 days preceding the day of study vaccination, (i.e. 30 days prior to Day 0) or planned use during the entire study period.
  • Receipt of any measles, mumps or rubella-containing vaccine during the period starting 42 days before the day of study vaccination (i.e. 42 days prior to Day 0).
  • Chronic administration (defined as 14 or more consecutive days) of immunosuppressants or other immune-modifying drugs during the period starting 180 days before study vaccination or any planned administration of immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
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  • Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to study vaccination through the immunogenicity evaluation at Visit 2 or Visit 3 (for one-dose or two-dose cohort, respectively).
  • Planned administration/ administration of any live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination and ending at Visit 2. Live intranasal influenza vaccine or any inactivated vaccine required in the age group may be given at any time, including the day of study vaccination.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • History of measles, mumps, or rubella disease.
  • Known exposure to measles, mumps, or rubella, during the period starting 30 days before study start (i.e. 30 days prior to Day 0).
  • %

Trial locations and contacts

17 sites in 3 countries.

17 sites in 3 countries

United States10 sites

  • GSK Investigational Site

    Birmingham, Alabama, 35211

  • GSK Investigational Site

    Chandler, Arizona, 85224

  • GSK Investigational Site

    Chicago, Illinois, 60654

  • GSK Investigational Site

    Cincinnati, Ohio, 45249

  • GSK Investigational Site

    Edina, Minnesota, 55435

  • GSK Investigational Site

    Mesa, Arizona

  • GSK Investigational Site

    Miami, Florida, 33144

  • GSK Investigational Site

    Miami, Florida, 33176

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    St Louis, Missouri, 63141

Other trials in United States

Slovakia6 sites

  • GSK Investigational Site

    Bratislava, 851 01

  • GSK Investigational Site

    Dolný Kubín, 026 01

  • GSK Investigational Site

    Dunajská Streda, 929 01

  • GSK Investigational Site

    Martin, 036 01

  • GSK Investigational Site

    Ružomberok, 034 01

  • GSK Investigational Site

    Zlaté Moravce, 953 01

Other trials in Slovakia

Estonia1 site

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

About this study

Official title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Seven Years and Older (209762)

The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.

Read the detailed description

This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.

Conditions
Rubella, Mumps, Measles
Being tested
Priorix®, Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
Keywords
Measles, mumps and rubella diseases, Safety, Immunogenicity
Medical subject headings
Rubella, Mumps, Measles

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Priorix®Biological

    1 dose administered as a subcutaneous (SC) injection.

  • Merck's M-M-R®II, Measles, Mumps, and Rubella Virus VaccineBiological

    1 dose administered subcutaneously.

Study groups in NCT02058563
Study groupRoleWhat they receive
INV_MMR GroupExperimentalSubjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®).
Receives: Biological: Priorix®
COM_MMR GroupActive comparatorSubjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.
Receives: Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine

What is being measured

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

  1. Anti-measles Virus Antibody Concentrations.

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.

    Measured: At Day 42

  2. Anti-mumps Virus Antibody Concentrations

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL

    Measured: At Day 42

  3. Anti-rubella Virus Antibody Concentrations.

    Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL

    Measured: At Day 42

Secondary outcomes (13)

  1. Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)

    Seroresponse was defined as:

    Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

    Measured: At Day 42

  2. Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).

    Seroresponse was defined as:

    Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

    Measured: At Day 42

  3. Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).

    Seroresponse was defined as:

    Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.

    Measured: At Day 42

  4. Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.

    For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.

    Measured: At Day 42

  5. Number of Subjects With Solicited Local Symptoms

    Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter >50mm. Grade 3 swelling = swelling with surface diameter >50mm.

    Measured: During the 4-day (Days 0-3) post-vaccination period

  6. Number of Subjects Reporting Fever

    Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever >39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.

    Measured: During the 43 days (Days 0-42) post-vaccination period.

  7. Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.

    Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.

    Measured: During the 43 days (Days 0-42) post-vaccination period.

  8. Number of Subjects Reporting Unsolicited AEs

    Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product

    Measured: During the 43 days (Days 0-42) post-vaccination period.

  9. Number of Subjects Reporting Solicited Rash Symptom

    Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.

    Measured: During the 43 days (Days 0-42) post-vaccination period.

  10. Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)

    Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.

    Measured: During the 43 days (Days 0-42) post-vaccination period.

  11. Number of Subjects Reporting NOCDs

    Occurrence of new onset chronic diseases (NOCDs)

    Measured: Day 0 through the end of the study (Day 180)

  12. Number of Subjects Reporting Adverse Events Prompting ER Visits

    Occurrence of AEs prompting emergency room (ER) visits.

    Measured: Day 0 through the end of the study (Day 180)

  13. Number of Subjects Reporting Serious Adverse Events (SAEs)

    A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

    Measured: Day 0 through the end of the study (Day 180)

Timeline

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

  1. First posted10 Feb 2014 (estimated)
  2. Study start1 Jul 2014
  3. Primary completion24 May 2015
  4. Study completion17 Sep 2015

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
996 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02058563
Sponsor's protocol ID
115231
Other IDs
2011-003672-36
Status last verified
May 2018
First submitted
6 Feb 2014
Last updated
6 Jun 2018

Publications

  • Abu-Elyazeed R, Jennings W, Severance R, Noss M, Caplanusi A, Povey M, Henry O. Immunogenicity and safety of a second dose of a measles-mumps-rubella vaccine administered to healthy participants 7 years of age or older: A phase III, randomized study. Hum Vaccin Immunother. 2018;14(11):2624-2631. doi: 10.1080/21645515.2018.1489186. Epub 2018 Jul 12.

    PubMed 29902133

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Priorix® and Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine in people with Rubella and Mumps, run by GlaxoSmithKline at 17 sites in 3 countries.

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 14 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States, Slovakia, Estonia. Whether a site is taking part right now should be confirmed with that site. See every site.

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 10 Apr 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?

Anti-measles Virus Antibody Concentrations. (time frame: At Day 42). The study lists 3 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 NCT02058563, 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 6 Jun 2018.

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