Measles-Mumps-RubellaPhase 3NCT01621802
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age
A Phase 3 study testing Priorix, M-M-R II and Kinrix in people with Measles-Mumps-Rubella, run by GlaxoSmithKline at 67 sites in 3 countries.
Trial summary
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles-Mumps-Rubella
- What is being tested?
- Priorix, M-M-R II and Kinrix
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,011 participants
- Where
- 67 sitesin 3 countries
- Study dates
- 21 Jun 2012to 9 Nov 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 4 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
- Male or female subjects 4 to 6 years of age at the time of vaccination.
- Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
- Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
- Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
- For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV:
- subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine.
- subjects received a first dose of VV in the second year of life.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
- Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter.
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- 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, and/or rubella disease.
- Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin.
- Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- 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°C (100.4°F) measured 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 according to the subject's medical history.
- Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study.
- In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV:
- Previous vaccination with a second dose of varicella-containing vaccine.
- Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination.
- History of varicella/zoster disease.
- Known exposure to varicella/zoster during the period starting 30 days prior to enrollment.
- History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease.
- Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life.
- Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids.
- Following a previous administration of DTP vaccine: temperature ≥40.6°C (>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine.
- Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
Trial locations and contacts
67 sites in 3 countries.
67 sites in 3 countries
United States50 sites
GSK Investigational Site
Altamonte Springs, Florida, 32701
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
Bardstown, Kentucky, 40004
GSK Investigational Site
Benton, Arkansas, 72019
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Burke, Virginia, 22015
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Cheraw, South Carolina, 29520
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Dayton, Ohio, 45414
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Fall River, Massachusetts, 02721
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Houston, Texas, 77055
GSK Investigational Site
Huntington, West Virginia, 25701
GSK Investigational Site
Indianapolis, Indiana, 46256
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Marietta, Georgia, 30062
GSK Investigational Site
Monroe, Wisconsin, 53566
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Newton, Kansas, 67114
GSK Investigational Site
Oakland, California, 94611
GSK Investigational Site
Pleasanton, California, 94588
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Raleigh, North Carolina, 27609
GSK Investigational Site
Rapid City, South Dakota, 57701
GSK Investigational Site
Sacramento, California, 95815
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Salt Lake City, Utah, 84109
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Tucson, Arizona, 85704
GSK Investigational Site
Tucson, Arizona, 85741
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
Woodstock, Georgia, 30189
South Korea12 sites
GSK Investigational Site
Ansan, 425-707
GSK Investigational Site
Daegu, 700-712
GSK Investigational Site
Daejeon, 301-723
GSK Investigational Site
Gyeonggi-do, 431-070
GSK Investigational Site
GyeongSangNam-do, 641-560
GSK Investigational Site
Iksan, 570-711
GSK Investigational Site
Jeollabukdo, 561712
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 130-702
GSK Investigational Site
Seoul, 139-706
GSK Investigational Site
Seoul, 158-710
GSK Investigational Site
Wonju-si Kangwon-do, 220-701
Taiwan5 sites
GSK Investigational Site
New Taipei City, 220
GSK Investigational Site
Taichung, 404
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 104
GSK Investigational Site
Taoyuan, 333
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
Read the detailed description
The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.
The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
- Conditions
- Measles-Mumps-Rubella
- Being tested
- Priorix, M-M-R II, Kinrix, ProQuad
- Keywords
- Safety, Measles, mumps and rubella diseases, Immunogenicity
- Medical subject headings
- Measles, Mumps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PriorixBiological
One dose administered subcutaneously in the triceps region of the right arm.
M-M-R IIBiological
One dose administered subcutaneously in the triceps region of the right arm.
KinrixBiological
One dose administered by deep intramuscular injection in the upper left deltoid.
ProQuadBiological
One dose administered subcutaneously in the triceps region of the left arm.
| Study group | Role | What they receive |
|---|---|---|
| Inv _MMR_CO Group | Experimental | Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Receives: Biological: Priorix; Biological: Kinrix; Biological: ProQuad |
| Com_MMR_CO Group | Active comparator | Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). Receives: Biological: M-M-R II; Biological: Kinrix; Biological: ProQuad |
| Inv_MMR_I Group | Experimental | Subjects received one dose of Priorix at Visit 1 (Day 0). Receives: Biological: Priorix |
| Com_MMR_I Group | Active comparator | Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Receives: Biological: M-M-R II |
| Inv _MMR_S Group | Experimental | Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). Receives: Biological: Priorix |
| Com_MMR_S Group | Active comparator | Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). Receives: Biological: M-M-R II |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number 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 equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days post vaccination (At Day 42)
Number 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 Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days post vaccination (At Day 42)
Number 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 Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days after vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Measured: 42 days post vaccination (At Day 42)
Secondary outcomes (20)
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Booster response was defined as:
For subjects with pre-vaccination antibody concentration less than (<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42.
For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Booster response was defined as:
For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42.
For initially seropositive subjects with pre-vaccination antibody concentration < 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration.
For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration.
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
Measured: 42 days post vaccination (At Day 42)
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . > 50mm.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination.
Analysis was done for sub-cohort 1 only.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Fever
Any fever = fever ≥ 38°C; Grade 3 fever = fever > 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting MMR Specific Solicited General Symptoms
Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. 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. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Rash
Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Measured: During the entire study period (from Day 0 up to Day 180)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
Measured: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Measured: During the entire study period (from Day 0 up to Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2012 (estimated)
- Study start21 Jun 2012
- Primary completion6 Jul 2015
- Study completion9 Nov 2015
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 Measles-Mumps-RubellaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01621802
- Sponsor's protocol ID
- 115158
- Other IDs
- 2011-004638-32
- Status last verified
- Nov 2019
- First submitted
- 14 Jun 2012
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20.
PubMed 30785357
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Subjects Four to Six Years of Age (209762)
- ClinicalTrials.gov ID
- NCT01621802
- Acronym / sponsor ID
- 115158
- Conditions
- Measles-Mumps-Rubella
- Keywords
- Safety, Measles, mumps and rubella diseases, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,011 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2012 (actual)
- Primary completion
- 6 Jul 2015 (actual)
- Study completion
- 9 Nov 2015 (actual)
- First posted
- 18 Jun 2012 (estimated)
- Results
- Posted 13 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
Detailed description
The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv_MMR vaccine and Com_MMR vaccine respectively. 2 lots of the comparator vaccine (Com_MMR_L1 and Com_MMR_L2) will be used, but the 2 lots will be analysed as a pool.
The Inv_MMR vaccine will be administered as a second dose to children who already received a first dose Com_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Inv _MMR_CO Group | Experimental | Biological: Priorix, Biological: Kinrix, Biological: ProQuadSubjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). |
| Com_MMR_CO Group | Active comparator | Biological: M-M-R II, Biological: Kinrix, Biological: ProQuadSubjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). |
| Inv_MMR_I Group | Experimental | Biological: PriorixSubjects received one dose of Priorix at Visit 1 (Day 0). |
| Com_MMR_I Group | Active comparator | Biological: M-M-R IISubjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). |
| Inv _MMR_S Group | Experimental | Biological: PriorixSubjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). |
| Com_MMR_S Group | Active comparator | Biological: M-M-R IISubjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol.
- Male or female subjects 4 to 6 years of age at the time of vaccination.
- Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations).
- Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history.
- Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life.
Key exclusion criteria (25 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period.
- Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s.
- Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2.
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 |
|---|---|---|
| PriorixOne dose administered subcutaneously in the triceps region of the right arm. | Biological | Inv _MMR_CO Group, Inv _MMR_S Group, Inv_MMR_I Group |
| M-M-R IIOne dose administered subcutaneously in the triceps region of the right arm. | Biological | Com_MMR_CO Group, Com_MMR_I Group, Com_MMR_S Group |
| KinrixOne dose administered by deep intramuscular injection in the upper left deltoid. | Biological | Com_MMR_CO Group, Inv _MMR_CO Group |
| ProQuadOne dose administered subcutaneously in the triceps region of the left arm. | Biological | Com_MMR_CO Group, Inv _MMR_CO Group |
Primary outcome
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: 42 days post vaccination (At Day 42)
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: 42 days post vaccination (At Day 42)
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: 42 days post vaccination (At Day 42)
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
Time frame: 42 days after vaccination (At Day 42)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
Time frame: 42 days post vaccination (At Day 42)
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
Time frame: 42 days post vaccination (At Day 42)
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
20 secondary outcomes
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Time frame: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Time frame: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Time frame: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Time frame: 42 days post vaccination (At Day 42)
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Time frame: 42 days post vaccination (At Day 42)
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Fever
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting MMR Specific Solicited General Symptoms
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Investigator-confirmed Rash
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With New Onset Chronic Diseases (NOCDs)
Time frame: During the entire study period (from Day 0 up to Day 180)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
Time frame: During the entire study period (from Day 0 up to Day 180)
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Day 180)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30785357MMR-158 Study Group. A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration. Hum Vaccin Immunother. 2019;15(4):786-799. doi: 10.1080/21645515.2018.1554971. Epub 2019 Feb 20.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
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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.
GSK Clinical Trials study director
GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
67 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Priorix, M-M-R II and Kinrix in people with Measles-Mumps-Rubella, run by GlaxoSmithKline at 67 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 8 inclusion and 25 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 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 67 sites in United States, South Korea, Taiwan. 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 13 Sep 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?
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (time frame: 42 days post vaccination (At Day 42)). The study lists 6 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 NCT01621802, 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 25 Nov 2019.