RubellaPhase 3NCT01702428
Consistency Study of GlaxoSmithKline (GSK) Biologicals' MMR Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Children 12 to 15 Months of Age
A Phase 3 study testing Priorix, M-M-R II and Varivax in people with Rubella and Measles, run by GlaxoSmithKline at 90 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US). 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
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,016 participants
- Where
- 90 sitesin 6 countries
- Study dates
- 9 Nov 2012to 16 Apr 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 at the time of vaccination.
- The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, 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:
- Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product 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.
- Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose 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.
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- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note:
- Inactivated influenza (Flu) vaccine and 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 prior to 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.
- 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.
- 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. 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:
- Child that previously received a vaccination with heptavalent Prevnar/Prevenar (prior vaccination should be with 3 doses of Prevnar 13 only).
- Child that previously received a fourth dose of any pneumococcal conjugate vaccine.
Trial locations and contacts
90 sites in 6 countries.
90 sites in 6 countries
United States62 sites
GSK Investigational Site
Ames, Iowa, 50010
GSK Investigational Site
Anaheim, California, 92804
GSK Investigational Site
Augusta, Kansas, 67010
GSK Investigational Site
Barnwell, South Carolina, 29812
GSK Investigational Site
Bossier City, Louisiana, 71111
GSK Investigational Site
Boston, Massachusetts, 02130
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Cleveland, Ohio, 44106
GSK Investigational Site
Colorado Springs, Colorado, 80920
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Columbia, Maryland, 21045
GSK Investigational Site
Daly City, California, 94015
GSK Investigational Site
Dothan, Alabama, 36305
GSK Investigational Site
Erie, Pennsylvania, 16505
GSK Investigational Site
Evergreen Park, Illinois, 60805
GSK Investigational Site
Fall River, Massachusetts, 02721
GSK Investigational Site
Falls Church, Virginia, 22042
GSK Investigational Site
Fayetteville, Arkansas, 72703
GSK Investigational Site
Fort Worth, Texas, 76107
GSK Investigational Site
Fresno, California, 93726
GSK Investigational Site
Hayward, California, 94545
GSK Investigational Site
Hermitage, Pennsylvania, 16148
GSK Investigational Site
Houston, Texas, 77070
GSK Investigational Site
Ithaca, New York, 14850
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
Los Gatos, California, 95032
GSK Investigational Site
Louisville, Kentucky, 40202
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Marshfield, Wisconsin, 54449
GSK Investigational Site
Mission Hills, California, 91345
GSK Investigational Site
Nampa, Idaho, 83686
GSK Investigational Site
Niles, Michigan, 49120
GSK Investigational Site
Overland Park, Kansas, 66213
GSK Investigational Site
Paramount, California, 90723
GSK Investigational Site
Payson, Utah, 84651
GSK Investigational Site
Phoenix, Arizona, 85048
GSK Investigational Site
Pleasanton, California, 94588
GSK Investigational Site
Provo, Utah, 84604
GSK Investigational Site
Richmond, Virginia, 23298
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
Salt Lake City, Utah, 84121
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
Santa Clara, California, 95051
GSK Investigational Site
Seattle, Washington, 98104
GSK Investigational Site
Sellersville, Pennsylvania, 18960
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Stevensville, Michigan, 49127
GSK Investigational Site
Syracuse, New York, 13210
GSK Investigational Site
Syracuse, Utah, 84075
GSK Investigational Site
The Bronx, New York, 10467
GSK Investigational Site
Tomball, Texas, 77375
GSK Investigational Site
Topeka, Kansas, 66604
GSK Investigational Site
Walnut Creek, California, 94596
GSK Investigational Site
Warwick, Rhode Island, 02886
GSK Investigational Site
West Jordan, Utah, 84088
Finland10 sites
GSK Investigational Site
Espoo, 02230
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
Spain10 sites
GSK Investigational Site
Castellon, 12004
GSK Investigational Site
Castellon, 12530
GSK Investigational Site
L'Eliana, Valencia, 46183
GSK Investigational Site
Quart de Poblet, Valencia, 46930
GSK Investigational Site
Valencia, 46011
GSK Investigational Site
Valencia, 46017
GSK Investigational Site
Valencia, 46020
GSK Investigational Site
Valencia, 46022
GSK Investigational Site
Valencia, 46023
GSK Investigational Site
Valencia, 46200
Estonia5 sites
GSK Investigational Site
Tallinn, 10117
GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tallinn, 13419
GSK Investigational Site
Tallinn, 13619
GSK Investigational Site
Tartu, 50106
Mexico2 sites
GSK Investigational Site
Durango, 34000
GSK Investigational Site
México, 04530
About this study
Official title: Consistency Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Healthy Children 12 to 15 Months of Age
The purpose of this study is to evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Read the detailed description
This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this document) in children during their second year of life. The INV_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.
- Being tested
- Priorix, M-M-R II, Varivax, Havrix, Prevnar 13
- Keywords
- Safety, Consistency study, Measles, mumps and rubella diseases, Healthy children, Immunogenicity
- Medical subject headings
- Rubella, Measles, Mumps
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 vaccine (GSK209762)
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
M-M-R IIBiological
Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
VarivaxBiological
Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
HavrixBiological
Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
Prevnar 13Biological
US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
| Study group | Role | What they receive |
|---|---|---|
| INV_MMR_L1 Group | Experimental | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Receives: Biological: Priorix; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13 |
| INV_MMR_L2 Group | Experimental | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Receives: Biological: Priorix; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13 |
| INV_MMR_L3 Group | Experimental | Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Receives: Biological: Priorix; Biological: Varivax; Biological: Havrix; Biological: Prevnar 13 |
| COM_MMR Group | Active comparator | Subjects receive 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group. 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.
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 ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
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/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
Anti-mumps Virus Antibody Concentration
Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
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/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
Anti-rubella Virus Antibody Concentration
Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Measured: At Day 42
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.
Measured: At Day 42
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in mIU/mL.
Measured: At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.
Measured: At Day 42
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in EU/mL.
Measured: At Day 42
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.
Measured: At Day 42
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
Antibody concentrations were expressed as GMCs in IU/mL.
Measured: At Day 42
Secondary outcomes (13)
Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥75 mIU/mL among subjects who were seronegative (antibody concentration <25 mIU/mL) before vaccination.
Measured: At Day 42
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Antibody concentrations were expressed as GMCs in mIU/mL.
Measured: At Day 42
Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Percentage of subjects with an Anti-HAV antibody concentration equal to or above 15 mIU/mL were reported.
Measured: At Day 42
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
Antibody concentrations were expressed as GMCs in mIU/mL.
Measured: At Day 42
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Antibody concentrations were expressed as GMCs in microgram/Milliliter (µg/mL).
Measured: At Day 42
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 4-days (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General AEs
Assessed solicited general AEs were drowsiness, irritability and loss of appetite. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 15-days (Days 0-14) post-vaccination period
Number of Subjects Reporting Any Fever
Any fever = Fever ≥ 38°C.
Measured: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash
Assessed were any localized or generalized rash, rash with fever, varicella-like rash, measles/rubella-like rash. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited AEs
Assessed MMR specific solicited AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AEs
Unsolicited adverse event (AE) was defined as any adverse event reported in addition to those solicited during the clinical study and also any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of the symptom regardless of intensity grade or relation to vaccination.
Measured: During the 43-days (Days 0-42) post-vaccination period
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: From Day 0 through the end of study (Day 180)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity. Any SAE = Occurrence of SAE regardless of intensity grade or relation to vaccination.
Measured: From Day 0 through the end of study (Day 180)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2012 (estimated)
- Study start9 Nov 2012
- Primary completion25 Nov 2014
- Study completion16 Apr 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 5,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01702428
- Sponsor's protocol ID
- 115648
- Other IDs
- 2011-004891-12
- Status last verified
- Nov 2019
- First submitted
- 4 Oct 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
Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.
PubMed 30849175
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
- Consistency Study of GSK Biologicals' Measles-mumps-rubella (MMR) Vaccine (209762) (Priorix) Comparing Immunogenicity and Safety to Merck & Co., Inc.'s MMR Vaccine (M-M-R II), in Healthy Children 12 to 15 Months of Age
- ClinicalTrials.gov ID
- NCT01702428
- Acronym / sponsor ID
- 115648
- Keywords
- Safety, Consistency study, Measles, mumps and rubella diseases, Healthy children, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,016 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2012 (actual)
- Primary completion
- 25 Nov 2014 (actual)
- Study completion
- 16 Apr 2015 (actual)
- First posted
- 8 Oct 2012 (estimated)
- Results
- Posted 28 Jun 2018
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 evaluate consistency in terms of the immune response to three different lots of GSK Biologicals' trivalent MMR vaccine manufactured to target potencies, and compare its immunogenicity to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Detailed description
This study will evaluate the consistency of the immune response to three different lots of GSK Biologicals' trivalent investigational MMR vaccine (referred to as INV_MMR vaccine, throughout this document) and compare its immunogenicity to the US standard of care comparator vaccine (M-M-R II, Merck and Co., Inc., referred to as COM_MMR throughout this document) in children during their second year of life. The INV_MMR vaccine will be given as one of three consistency lots manufactured to target potencies designated as INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3. The COM_MMR vaccine will be given as one of two lots designated COM_MMR_L1 and COM_MMR_L2 and will be analysed as pooled lots within the study. The MMR vaccine will be co-administered with Varivax (VV), Havrix (HAV) and (in the US sub-cohort only) Prevnar 13 (PCV-13) which are routinely administered to children of this age in the US.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| INV_MMR_L1 Group | Experimental | Biological: Priorix, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 1 (L1) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| INV_MMR_L2 Group | Experimental | Biological: Priorix, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 2 (L2) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| INV_MMR_L3 Group | Experimental | Biological: Priorix, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive 1 dose of GSK's candidate combined measles, mumps and rubella (MMR) investigational vaccine (INV_MMR) Lot 3 (L3) co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| COM_MMR Group | Active comparator | Biological: M-M-R II, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive 1 dose of COM_MMR Lot 1 and Lot 2 co-administered with VV and HAV vaccines at Visit 1 (Day 0). All US subjects are also given PCV-13 vaccine. The MMR vaccine is administered subcutaneously in the triceps region of the left arm while the VV vaccine is administered subcutaneously in the triceps region of the right arm. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. Pooled analysis is conducted for this group. |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female child between 12 and 15 months of age at the time of vaccination.
- The investigator believes that the parent(s) or Legally Acceptable Representative(s) (LAR(s)) of the child, 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.
- Child that previously received a 3-dose series of Prevnar 13 only (i.e., no doses given as Prevnar/Prevenar), with the last dose at least 60 days prior to study entry.
Key exclusion criteria (23 listed)
- Child in care.
- Use of any investigational or non-registered product 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.
- Chronic administration of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1 and ending at Visit 2. Please Note:
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 |
|---|---|---|
| PriorixAlso: GSK Biologicals' live attenuated measles, mumps and rubella vaccine (GSK209762)Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm. | Biological | INV_MMR_L1 Group, INV_MMR_L2 Group, INV_MMR_L3 Group |
| M-M-R IISubjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm. | Biological | COM_MMR Group |
| VarivaxSubjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm. | Biological | COM_MMR Group, INV_MMR_L1 Group, INV_MMR_L2 Group, INV_MMR_L3 Group |
| HavrixSubjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh. | Biological | COM_MMR Group, INV_MMR_L1 Group, INV_MMR_L2 Group, INV_MMR_L3 Group |
| Prevnar 13US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh. | Biological | COM_MMR Group, INV_MMR_L1 Group, INV_MMR_L2 Group, INV_MMR_L3 Group |
Primary outcome
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 milli International Unit/Milliliter (mIU/mL) among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Anti-measles Virus Antibody Concentrations
Time frame: At Day 42
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 ELISA Unit/Milliliter (EU/mL) among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Anti-mumps Virus Antibody Concentration
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in EU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 International Unit/Milliliter (IU/mL) among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Anti-rubella Virus Antibody Concentration
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in IU/mL. This outcome measure is applicable to reporting groups INV_MMR_L1, INV_MMR_L2 and INV_MMR_L3 as analysis was performed on subjects who received one of the lots of INV_MMR vaccine.
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥200 mIU/mL among subjects who were seronegative (antibody concentration <150 mIU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to measles virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to measles virus.
Anti-measles Virus Antibody Concentrations in Pooled MMR Groups
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in mIU/mL.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥10 EU/mL among subjects who were seronegative (antibody concentrations <5 EU/mL) before vaccination.
Anti-mumps Virus Antibody Concentration in Pooled MMR Groups
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in EU/mL.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value in Pooled MMR Groups
Time frame: At Day 42
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥10 IU/mL among subjects who were seronegative (antibody concentrations <4 IU/mL) before vaccination. Criteria to demonstrate an acceptable immune response for INV_MMR in terms of seroresponse rates to rubella virus at Day 42: The LL of 2-sided 95% CI for the seroresponse rate for the pooled INV_MMR lots is ≥90% for antibodies to rubella virus.
Anti-rubella Virus Antibody Concentration in Pooled MMR Groups
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in IU/mL.
13 secondary outcomes
Percentage of Subjects With an Anti-Varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Time frame: At Day 42
Anti-VZV Virus Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Time frame: At Day 42
Percentage of Subjects With an Anti-HAV Antibody Concentration Equal to or Above the Cut-off Value in US Sub-cohort of Pooled MMR Groups
Time frame: At Day 42
Anti-HAV Antibody Concentrations in US Sub-cohort of Pooled MMR Groups
Time frame: At Day 42
Anti-S.Pneumoniae Antibody Concentration in US Sub-cohort of Pooled MMR Groups
Time frame: At Day 42
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Time frame: During the 4-days (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General AEs
Time frame: During the 15-days (Days 0-14) post-vaccination period
Number of Subjects Reporting Any Fever
Time frame: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash
Time frame: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited AEs
Time frame: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AEs
Time frame: During the 43-days (Days 0-42) post-vaccination period
Number of Subjects Reporting AEs of Specific Interest
Time frame: From Day 0 through the end of study (Day 180)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: From Day 0 through the end of study (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 30849175Klein NP, Abu-Elyazeed R, Povey M, Macias Parra M, Diez-Domingo J, Ahonen A, Korhonen T, Tinoco JC, Weiner L, Marshall GS, Silas PE, Sarpong KO, Ramsey KP, Fling JA, Speicher D, Campos M, Munjal I, Peltier C, Vesikari T, Baccarini C, Caplanusi A, Gillard P, Carryn S, Henry O. Immunogenicity and Safety of a Measles-Mumps-Rubella Vaccine Administered as a First Dose to Children Aged 12 to 15 Months: A Phase III, Randomized, Noninferiority, Lot-to-Lot Consistency Study. J Pediatric Infect Dis Soc. 2020 Apr 30;9(2):194-201. doi: 10.1093/jpids/piz010.
- 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
90 sites in 6 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 Varivax in people with Rubella and Measles, run by GlaxoSmithKline at 90 sites in 6 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 6 inclusion and 23 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 90 sites in United States, Finland, Spain, Estonia, Mexico and 1 more country. 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 28 Jun 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?
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (time frame: At Day 42). The study lists 12 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 NCT01702428, 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.