AzTrials
AzTrials

Measles; Mumps; RubellaPhase 3NCT02184572

Safety and Immunogenicity Study of GlaxoSmithKline (GSK) Biologicals' Measles, Mumps and Rubella (MMR) Vaccine (209762) Compared to Merck & Co., Inc.'s MMR Vaccine in Healthy Children 12 to 15 Months of Age

A Phase 3 study testing Priorix, M-M-R II and Varivax in people with Measles; Mumps; Rubella and Measles-Mumps-Rubella Vaccine, run by GlaxoSmithKline at 95 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age. Read more about this study

Who is it for?
Ages 12 to 15 monthsHealthy volunteers can take part
What is being tested?
Priorix, M-M-R II and Varivax
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,742 participants
Where
95 sitesin 5 countries
Study dates
25 Aug 2014to 22 Dec 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 12 to 15 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Male or female child between 12 and 15 months of age (e.g., from the 1 year birthday until the day before age 16 months) at the time of vaccination.
  • Subjects' parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol.
  • Written informed consent obtained from the parent(s)/LAR(s) of the child.
  • Child is in stable health as determined by investigator's clinical examination and assessment of child's medical history.
  • For US children only: a child who received all routine vaccinations as per ACIP recommendations prior to study entry: completion of hepatitis B and rotavirus series and completion of the primary series of diphtheria, tetanus, pertussis, poliovirus, Haemophilus influenzae type b (Hib) and pneumococcal vaccines. The 3-dose infant series of Prevnar 13 should be completed at least 60 days prior to study vaccination.

Who cannot join

  • Child in care.
  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Day 0) or planned use during the entire study period.
  • Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the study vaccination at Visit 1 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
  • For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
  • Inhaled and topical steroids are allowed.
Show all 21Show fewer
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the day of study vaccination at Visit 1 and ending at Visit 2. Please Note:
  • Inactivated influenza (Flu) vaccine and monovalent Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
  • Any other age appropriate vaccine may be given starting at Visit 2 and anytime thereafter.
  • Administration of immunoglobulins and/or any blood products during the period starting 180 days before the study vaccination at Visit 1 or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
  • History of measles, mumps, rubella, varicella/zoster and/or hepatitis A disease.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting within 30 days prior to first study vaccination.
  • Previous vaccination against measles, mumps, rubella, hepatitis A and/or varicella virus.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin, latex or gelatin.
  • Acute disease at the time of enrollment. (Acute disease is defined as the presence of a moderate or severe illness with or without fever). Fever is defined as temperature ≥38.0°C/100.4°F by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever.
  • Active untreated tuberculosis based on medical history.
  • Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.
  • For US children only: a child that previously received a fourth dose of PCV-13 vaccine.

Trial locations and contacts

95 sites in 5 countries.

95 sites in 5 countries

United States80 sites

  • GSK Investigational Site

    Anaheim, California, 92804

  • GSK Investigational Site

    Asheboro, North Carolina, 27203

  • GSK Investigational Site

    Augusta, Kansas, 67010

  • GSK Investigational Site

    Baldwin Park, California, 91706

  • GSK Investigational Site

    Baltimore, Maryland, 21021

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Binghamton, New York, 13901

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Boone, North Carolina, 28607

  • GSK Investigational Site

    Bossier City, Louisiana, 71111

  • GSK Investigational Site

    Boston, Massachusetts, 02118

  • GSK Investigational Site

    Boston, Massachusetts, 02130

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Cheraw, South Carolina, 29520

  • GSK Investigational Site

    Cleveland, Ohio, 44106

  • GSK Investigational Site

    Cleveland, Ohio, 44121

  • GSK Investigational Site

    Clyde, North Carolina, 28721

  • GSK Investigational Site

    Colorado Springs, Colorado, 80922

  • GSK Investigational Site

    Columbia, Maryland, 21045

  • GSK Investigational Site

    Columbus, Ohio, 43213

  • GSK Investigational Site

    Daly City, California, 94015

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    Dayton, Ohio, 45414

  • GSK Investigational Site

    Ellensburg, Washington, 98926

  • GSK Investigational Site

    Erie, Pennsylvania, 16505

  • GSK Investigational Site

    Fayetteville, Arkansas, 72703

  • GSK Investigational Site

    Frederick, Maryland, 21702

  • GSK Investigational Site

    Fresno, California, 93726

  • GSK Investigational Site

    Hayward, California, 94545

  • GSK Investigational Site

    Huntington, West Virginia, 25701

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kansas City, Missouri, 64114

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    League City, Texas, 77573

  • GSK Investigational Site

    Lincoln, Nebraska, 68504

  • GSK Investigational Site

    Lincoln, Nebraska, 68505

  • GSK Investigational Site

    Lincoln, Nebraska, 68516

  • GSK Investigational Site

    Mandan, North Dakota, 58501

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Miami Lakes, Florida, 33014

  • GSK Investigational Site

    Monroe, Wisconsin, 53566

  • GSK Investigational Site

    Murray, Utah, 84124

  • GSK Investigational Site

    Nampa, Idaho, 83686

  • GSK Investigational Site

    Newton, Kansas, 67114

  • GSK Investigational Site

    Niles, Michigan, 49120

  • GSK Investigational Site

    Norwich, Connecticut, 06360

  • GSK Investigational Site

    Oakland, California, 94611

  • GSK Investigational Site

    Omaha, Nebraska, 68114

  • GSK Investigational Site

    Orem, Utah, 84057

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Payson, Utah, 84651

  • GSK Investigational Site

    Pleasanton, California, 94588

  • GSK Investigational Site

    Provo, Utah, 84604

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Roseville, California, 95661

  • GSK Investigational Site

    Roy, Utah, 84067

  • GSK Investigational Site

    Sacramento, California, 95815

  • GSK Investigational Site

    Sacramento, California, 95823

  • GSK Investigational Site

    Salt Lake City, Utah, 84109

  • GSK Investigational Site

    San Jose, California, 95119

  • GSK Investigational Site

    Santa Clara, California, 95051

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57105

  • GSK Investigational Site

    Sioux Falls, South Dakota, 57108

  • GSK Investigational Site

    South Jordan, Utah, 84095

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

  • GSK Investigational Site

    St. George, Utah, 84790

  • GSK Investigational Site

    Stevensville, Michigan, 49127

  • GSK Investigational Site

    Syracuse, New York, 13202

  • GSK Investigational Site

    Syracuse, New York, 13210

  • GSK Investigational Site

    Syracuse, Utah, 84075

  • GSK Investigational Site

    Tomball, Texas, 77375

  • GSK Investigational Site

    Topeka, Kansas, 66604

  • GSK Investigational Site

    Tucson, Arizona, 85741

  • GSK Investigational Site

    Walnut Creek, California, 94596

  • GSK Investigational Site

    Watertown, South Dakota, 57201

  • GSK Investigational Site

    West Jordan, Utah, 84088

Other trials in United States

Finland6 sites

  • GSK Investigational Site

    Espoo, 02230

  • GSK Investigational Site

    Helsinki, 00100

  • GSK Investigational Site

    Helsinki, 00930

  • GSK Investigational Site

    Jarvenpaa, 04400

  • GSK Investigational Site

    Tampere, 33100

  • GSK Investigational Site

    Turku, 20520

Other trials in Finland

Taiwan5 sites

  • GSK Investigational Site

    Taichung, 404

  • GSK Investigational Site

    Taichung, 407

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Taipei, 104

  • GSK Investigational Site

    Taoyuan, 333

Other trials in Taiwan

Puerto Rico3 sites

  • GSK Investigational Site

    Guayama, 00784

  • GSK Investigational Site

    Ponce, 00716

  • GSK Investigational Site

    San Juan, 00936-5067

Other trials in Puerto Rico

Estonia1 site

  • GSK Investigational Site

    Tartu, 50106

Other trials in Estonia

About this study

Official title: Safety and Immunogenicity Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine, in Healthy Children 12 to 15 Months of Age

The purpose of this study is to evaluate the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.

Read the detailed description

This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US.

All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.

Being tested
Priorix, M-M-R II, Varivax, Havrix, Prevnar 13
Keywords
Rubella, Healthy children, Measles, Safety, Mumps, 12 to 15 months, Immunogenicity
Medical subject headings
Measles, Mumps, Rubella

What participants receive

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

  • PriorixBiological

    Also called GSK Biologicals' live attenuated measles, mumps and rubella (MMR) vaccine

    1 dose administered subcutaneously in the triceps region of left arm at Day 0

  • M-M-R IIBiological

    Also called MMR vaccine live (M-M R II, Merck & Co., Inc., or M-M-R VaxPro

    1 dose administered subcutaneously in the triceps region of left arm at Day 0

  • VarivaxBiological

    Also called Merck & Co. Inc.'s Varicella virus vaccine, live

    1 dose administered subcutaneously in the triceps region of right arm at Day 0

  • HavrixBiological

    Also called GSK Biologicals' Hepatitis A vaccine, inactivated

    1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0

  • Prevnar 13Biological

    Also called Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)

    1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US

Study groups in NCT02184572
Study groupRoleWhat they receive
INV_MMRExperimentalSubjects receive 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
Receives: Biological: Priorix; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13
COM_MMRActive comparatorSubjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
Receives: Biological: M-M-R II; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13

What is being measured

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

  1. Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination

    Fever was assessed for temperature equal to/above (≥) 38.0°C and above (>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.

    Measured: During Day 5 to Day 12 post-vaccination period

Secondary outcomes (15)

  1. Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to [≥] 200 milli International Units per milliliter [mIU/mL] (Enzyme-Linked Immunosorbent Assay [ELISA], Enzygnost) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before vaccination.

    Measured: At Day 42 post vaccination

  2. Anti-measles Virus Antibody Concentrations

    Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.

    Measured: At Day 42 post vaccination

  3. Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter [EU/mL] (ELISA, Pharmaceutical Product Development, Inc.[PPD]) among subjects who were seronegative (antibody concentration < 5 EU/mL) before vaccination.

    Measured: At Day 42 post vaccination

  4. Anti-mumps Virus Antibody Concentrations

    Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.

    Measured: At Day 42 post vaccination

  5. Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value

    Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter [IU/mL] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration < 4 IU/mL) before vaccination.

    Measured: At Day 42 post vaccination

  6. Anti-rubella Virus Antibody Concentrations

    Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.

    Measured: At Day 42 post vaccination

  7. Number of Subjects With Any Solicited Local Adverse Events (AEs)

    Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.

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

  8. Number of Subjects With Any Solicited General AEs

    Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.

    Measured: During the 15-day (Days 0-14) post-vaccination period

  9. Number of Subjects Reporting Any Fever

    Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.

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

  10. Number of Subjects Reporting Any Rash

    Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.

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

  11. Number of Subjects Reporting MMR Specific Solicited General AEs

    Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.

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

  12. Number of Subjects Reporting Any Unsolicited AEs

    Unsolicited AE included any AE reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited AEs. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.

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

  13. Number of Subjects Reporting AEs of Specific Interest

    AEs of specific interest included new onset chronic disease (NOCD) (e.g., autoimmune disorders, asthma, type I diabetes, vasculitis, celiac disease, conditions associated with sub-acute or chronic thrombocytopenia and allergies) and AEs prompting emergency room (ER) visits.

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

  14. Number of Subjects Reporting Any Serious Adverse Events (SAEs)

    SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.

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

  15. Number of Subjects Reporting Measles-like Illness

    Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis:

    maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.

    Measured: During Day 5 to Day 12 post-vaccination period

Timeline

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

  1. First posted9 Jul 2014 (estimated)
  2. Study start25 Aug 2014
  3. Primary completion14 Aug 2015
  4. Study completion22 Dec 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
1,742 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02184572
Sponsor's protocol ID
115650
Other IDs
2011-006161-18
Status last verified
Dec 2020
First submitted
3 Jul 2014
Last updated
7 Jan 2021

Publications

  • MMR-162 Study Group. Safety and immunogenicity of an upper-range release titer measles-mumps-rubella vaccine in children vaccinated at 12 to 15 months of age: a phase III, randomized study. Hum Vaccin Immunother. 2018;14(12):2921-2931. doi: 10.1080/21645515.2018.1502527. Epub 2018 Aug 29.

    PubMed 30118386

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Priorix, M-M-R II and Varivax in people with Measles; Mumps; Rubella and Measles-Mumps-Rubella Vaccine, run by GlaxoSmithKline at 95 sites in 5 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 5 inclusion and 21 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 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Finland, Taiwan, Puerto Rico, 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 3 Jul 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?

Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination (time frame: During Day 5 to Day 12 post-vaccination period). 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 NCT02184572, 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 7 Jan 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in