MeaslesPhase 3NCT01681992
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Children in Their Second Year of Life
A Phase 3 study testing Priorix, M-M-R II and Varivax in people with Measles and Mumps, run by GlaxoSmithKline at 81 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it 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
- 4,538 participants
- Where
- 81 sitesin 7 countries
- Study dates
- 10 Oct 2012to 18 Aug 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 with 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 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.
- Inhaled and topical steroids are allowed.
- 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 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
- Inactivated influenza (Flu) vaccine and Haemophilus influenzae type b conjugate vaccine (Hib) vaccines may be given at any time during the study, including the day of study vaccination (Flu and Hib vaccines must be administered at a different location than the study vaccine/s).
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- Any age appropriate vaccine may be given starting at Visit 2 (or starting at Visit 3 for the US post-dose 2 sub-cohort), 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, or at Visit 3 for the US post-dose 2 sub-cohort.
- History of measles, mumps, rubella, varicella/zoster and/or hepatitis A diseases.
- Known exposure to measles, mumps, rubella and/or varicella/zoster during the period starting 30 days prior to the 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. 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 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 any pneumococcal conjugate vaccine.
Trial locations and contacts
81 sites in 7 countries.
81 sites in 7 countries
United States40 sites
GSK Investigational Site
Altamonte Springs, Florida, 32701
GSK Investigational Site
Annapolis, Maryland, 21401
GSK Investigational Site
Baltimore, Maryland, 21201
GSK Investigational Site
Birmingham, Alabama, 35205
GSK Investigational Site
Charleston, South Carolina, 29406
GSK Investigational Site
Charleston, South Carolina, 29414
GSK Investigational Site
Cleveland, Ohio, 44121
GSK Investigational Site
Clyde, North Carolina, 28721
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Dayton, Ohio, 45414
GSK Investigational Site
Ellensburg, Washington, 98926
GSK Investigational Site
Frederick, Maryland, 21702
GSK Investigational Site
Gresham, Oregon, 97030
GSK Investigational Site
Houston, Texas, 77087
GSK Investigational Site
Johnstown, Pennsylvania, 15904
GSK Investigational Site
Jonesboro, Arkansas, 72401
GSK Investigational Site
Kansas City, Missouri, 64108
GSK Investigational Site
Layton, Utah, 84041
GSK Investigational Site
Lincoln, Nebraska, 68504
GSK Investigational Site
Lincoln, Nebraska, 68505
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Louisville, Kentucky, 40207
GSK Investigational Site
Miami, Florida, 33184
GSK Investigational Site
Miami Lakes, Florida, 33014
GSK Investigational Site
Midlothian, Virginia, 23113
GSK Investigational Site
Muncie, Indiana, 47304-5547
GSK Investigational Site
Naples, Florida, 34102
GSK Investigational Site
New Albany, Indiana, 47150
GSK Investigational Site
Omaha, Nebraska, 68131
GSK Investigational Site
Phoenix, Arizona, 85012
GSK Investigational Site
Phoenix, Arizona, 85032
GSK Investigational Site
Richmond, Virginia, 23223
GSK Investigational Site
Springville, Utah, 84663
GSK Investigational Site
St. George, Utah, 84790
GSK Investigational Site
Tampa, Florida, 33606
GSK Investigational Site
Toledo, Ohio, 43606
GSK Investigational Site
West Covina, California, 91790
GSK Investigational Site
West Des Moines, Iowa, 50265
GSK Investigational Site
Wichita, Kansas, 67205
GSK Investigational Site
Youngstown, Ohio, 44514
Czechia12 sites
GSK Investigational Site
Benešov, 256 01
GSK Investigational Site
Chlumec nad Cidlinou, 50351
GSK Investigational Site
Děčín, 405 01
GSK Investigational Site
Jindřichův Hradec, 37701
GSK Investigational Site
Kladno, 272 01
GSK Investigational Site
Liberec, 46015
GSK Investigational Site
Lipník nad Bečvou, 75131
GSK Investigational Site
Náchod, 547 01
GSK Investigational Site
Odolena Voda, 25070
GSK Investigational Site
Ostrava - Poruba, 70800
GSK Investigational Site
Pardubice, 532 03
GSK Investigational Site
Prague, 1600
Spain12 sites
GSK Investigational Site
Antequera/Málaga, 29200
GSK Investigational Site
Barcelona, 08042
GSK Investigational Site
Centelles (Barcelona), 08540
GSK Investigational Site
L'Eliana, Valencia, 46183
GSK Investigational Site
Manlleu, 08560
GSK Investigational Site
Quart de Poblet, Valencia, 46930
GSK Investigational Site
Santiago de Compostela, 15706
GSK Investigational Site
Seville, 41014
GSK Investigational Site
Valencia, 46020
GSK Investigational Site
Valencia, 46024
GSK Investigational Site
Valencia, 46200
GSK Investigational Site
Vic, 08500
Finland6 sites
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
Thailand5 sites
GSK Investigational Site
Bangkok, 10330
GSK Investigational Site
Bangkok, 10400
GSK Investigational Site
Bangkok, 10700
GSK Investigational Site
Chiang Mai, 50200
GSK Investigational Site
Pathum Thani, 12120
Malaysia3 sites
GSK Investigational Site
Kuala Terengganu, 20400
GSK Investigational Site
Kuching, 93586
GSK Investigational Site
Sibu, 96000
Puerto Rico3 sites
GSK Investigational Site
Guayama, 00784
GSK Investigational Site
Ponce, 00716
GSK Investigational Site
San Juan, 00936-5067
About this study
Official title: Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life
The purpose of this study is to evaluate end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Read the detailed description
This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR vaccine, throughout this document) in contrast 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 first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of these Inv_MMR groups will have a potency within the release range of the marketed vaccine. The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 13 which are routinely administered to children of this age in the US.
- Conditions
- Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine
- Being tested
- Priorix, M-M-R II, Varivax, Havrix, Prevnar 13
- Keywords
- Safety, Measles, mumps and rubella diseases, 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, rubella vaccine
Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
M-M-R IIBiological
Also called Merck & Co., Inc.'s measles, mumps, rubella virus vaccine
Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
VarivaxBiological
Also called Merck & Co., Inc.'s varicella virus vaccine, live
Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
HavrixBiological
Also called GSK Biologicals' hepatitis A vaccine, inactivated
Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), 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)
US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
| Study group | Role | What they receive |
|---|---|---|
| Inv_MMR_Min Group | Experimental | Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. 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_Med Group | Experimental | Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. 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 one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. 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 (by Enzyme-linked Immunosorbent Assay [ELISA])
For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.
Measured: At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
Measured: At Day 42
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])
For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.
Measured: At Day 42
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
Measured: At Day 42
Anti-measles Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Measured: At Day 42
Anti-mumps Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in EU/mL.
Measured: At Day 42
Anti-mumps Virus Antibody Concentrations (by PRNT)
Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
Measured: At Day 42
Anti-rubella Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in IU/mL.
Measured: At Day 42
Secondary outcomes (19)
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration ≥ 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration < 150 mIU/mL) before dose 1.
Measured: At Day 84
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1.
Measured: At Day 84
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1.
Measured: At Day 84
Anti-measles Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in mIU/mL.
Measured: At Day 84
Anti-mumps Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in EU/mL.
Measured: At Day 84
Anti-rubella Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in IU/mL.
Measured: At Day 84
Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1
Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited Local AEs Post Dose 2
Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General AEs Post Dose 1
Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting Any Fever Post Dose 1
Any fever = Fever (axillary) ≥ 38°C.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Fever Post Dose 2
Any fever = Fever (axillary) ≥ 38°C.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash Post Dose 1
Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash Post Dose 2
Assessed were any localized or generalized rash, rash with fever, varicella-like rash and measles/rubella-like rash. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1
Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2
Assessed MMR specific solicited general AEs were any suspected signs of meningism including febrile convulsions and parotid/salivary gland swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AES Post Dose 1
Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AES Post Dose 2
Unsolicited AE was defined as any AE reported in 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 the AE regardless of intensity grade or relation to vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any 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 the study (Day 222)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAEs assessed include any untoward medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity.
Measured: From Day 0 through the end of the study (Day 222)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study start10 Oct 2012
- Primary completion3 Feb 2015
- Study completion18 Aug 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 MeaslesStudies 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
- 4,538 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
- NCT01681992
- Sponsor's protocol ID
- 115649
- Other IDs
- 2011-004905-26
- Status last verified
- Dec 2020
- First submitted
- 6 Sep 2012
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
Publications
MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.
PubMed 30104117
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety Study of GSK Biologicals' Priorix Vaccine (209762) at an End of Shelf-life Potency Compared to Merck & Co., Inc.'s Measles-mumps-rubella (MMR) Vaccine When Both Are Given on a 2-dose Schedule to Healthy Children in Their 2nd Year of Life
- ClinicalTrials.gov ID
- NCT01681992
- Acronym / sponsor ID
- 115649
- Conditions
- Measles, Mumps, Rubella, Measles-Mumps-Rubella Vaccine
- Keywords
- Safety, Measles, mumps and rubella diseases, Immunogenicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,538 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2012 (actual)
- Primary completion
- 3 Feb 2015 (actual)
- Study completion
- 18 Aug 2015 (actual)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Posted 17 Aug 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 end of shelf-life potency in terms of the immunogenicity and safety of GSK Biologicals' trivalent MMR vaccine, by comparing it to Merck \& Co., Inc.'s MMR vaccine, which is approved for use in the United States (US).
Detailed description
This trial is a Phase IIIA, randomized, observer-blind, controlled, multi-center, multi-country study with four parallel groups. This study will evaluate the immunogenicity and safety of GSK Biologicals' trivalent investigational MMR vaccine (referred to as Inv_MMR vaccine, throughout this document) in contrast 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 first dose of this two-dose study is designed to establish the end of shelf-life potency of Inv_MMR vaccine. The Inv_MMR vaccine will be given as one of two lots; one of a minimum potency, designated Inv_MMR_Min; and the other at a mid-range or medium potency designated Inv_MMR_Med to two groups. The second dose for both of these Inv_MMR groups will have a potency within the release range of the marketed vaccine. The Com_MMR vaccine will consist of two lots designated Com_MMR_L1 and Com_MMR_L2 and will be analyzed as pooled lots within the study. The first MMR vaccine dose will be co-administered with Varivax, Havrix and (in the US sub-cohort only) Prevnar 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Inv_MMR_Min Group | Experimental | Biological: Priorix, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a minimum potency lot (Inv_MMR_Min), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
| Inv_MMR_Med Group | Experimental | Biological: Priorix, Biological: Varivax, Biological: Havrix, Biological: Prevnar 13Subjects receive one dose of GlaxoSmithKline (GSK) Biologicals' measles, mumps, rubella (MMR) vaccine, Priorix (Inv_MMR), from a mid-range or medium potency lot (Inv_MMR_Med), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose from a separate lot of the Inv_MMR vaccine (Inv_MMR_Release), for the second dose. Inv_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. 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 one dose of M-M-R II (Com_MMR) vaccine (Lot 1 or Lot 2), co-administered with Varivax (VV) and Havrix (HAV) vaccines at Day 0. All US subjects are also co-administered Prevnar 13 (PCV-13) vaccine. Approximately 6 weeks later, at Day 42, subjects are administered a dose of Com_MMR vaccine (Lot 1 or Lot 2), for the second dose. Com_MMR and VV vaccines are administered subcutaneously in the triceps region of the left and right arm, respectively. HAV and PCV-13 vaccines are administered intramuscularly in the anterolateral region of the right and left thigh, respectively. |
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 with last dose at least 60 days prior to study entry.
Key exclusion criteria (20 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 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 (or ending at Visit 3 for the US post-dose 2 sub-cohort). Please Note:
- 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, or at Visit 3 for the US post-dose 2 sub-cohort.
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, rubella vaccineSubjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm. | Biological | Inv_MMR_Med Group, Inv_MMR_Min Group |
| M-M-R IIAlso: Merck & Co., Inc.'s measles, mumps, rubella virus vaccineSubjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm. | Biological | Com_MMR Group |
| VarivaxAlso: Merck & Co., Inc.'s varicella virus vaccine, liveSubjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0. | Biological | Com_MMR Group, Inv_MMR_Med Group, Inv_MMR_Min Group |
| HavrixAlso: GSK Biologicals' hepatitis A vaccine, inactivatedSubjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0. | Biological | Com_MMR Group, Inv_MMR_Med Group, Inv_MMR_Min Group |
| Prevnar 13Also: Pfizer Inc.'s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0. | Biological | Com_MMR Group, Inv_MMR_Med Group, Inv_MMR_Min Group |
Primary outcome
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by Enzyme-linked Immunosorbent Assay [ELISA])
Time frame: At Day 42
For measles virus, a seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal or above [≥] 200 mIU/mL (ELISA) among subjects who were seronegative (antibody concentration less than [<] 150 mIU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for measles virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to measles virus.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
Time frame: At Day 42
For mumps virus, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 EU/mL (ELISA) among subjects who were seronegative (antibody concentration < 5 EU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for mumps virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by Plaque Reduction Neutralization Test [PRNT])
Time frame: At Day 42
For mumps virus as measured by PRNT, a seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 4 End point Dilution 50% (ED50) (PRNT) among subjects who were seronegative (antibody concentration < 2.5 ED50) before dose 1.
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
Time frame: At Day 42
For rubella virus, a seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 IU/mL (ELISA) among subjects who were seronegative (antibody concentration < 4 IU/mL) before dose 1. Criteria to demonstrate an acceptable immune response of Inv_MMR_Min/Inv_MMR_Med vaccine in terms of seroresponse rate for rubella virus at Day 42: The lower limit of the two-sided 97.5% CI for the seroresponse rate of Inv_MMR_Min/Inv_MMR_Med was to be ≥ 90% for antibodies to mumps virus.
Anti-measles Virus Antibody Concentrations (by ELISA)
Time frame: At Day 42
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Anti-mumps Virus Antibody Concentrations (by ELISA)
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in EU/mL.
Anti-mumps Virus Antibody Concentrations (by PRNT)
Time frame: At Day 42
Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
Anti-rubella Virus Antibody Concentrations (by ELISA)
Time frame: At Day 42
Antibody concentrations were expressed as GMCs in IU/mL.
19 secondary outcomes
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
Time frame: At Day 84
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
Time frame: At Day 84
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value (by ELISA)
Time frame: At Day 84
Anti-measles Virus Antibody Concentrations (by ELISA)
Time frame: At Day 84
Anti-mumps Virus Antibody Concentrations (by ELISA)
Time frame: At Day 84
Anti-rubella Virus Antibody Concentrations (by ELISA)
Time frame: At Day 84
Number of Subjects With Any Solicited Local Adverse Events (AEs) Post Dose 1
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited Local AEs Post Dose 2
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General AEs Post Dose 1
Time frame: During the 15-day (Days 0-14) post-vaccination period
Number of Subjects Reporting Any Fever Post Dose 1
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Fever Post Dose 2
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash Post Dose 1
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Rash Post Dose 2
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 1
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any MMR Specific Solicited General AEs Post Dose 2
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AES Post Dose 1
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any Unsolicited AES Post Dose 2
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects Reporting Any AEs of Specific Interest
Time frame: From Day 0 through the end of the study (Day 222)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
Time frame: From Day 0 through the end of the study (Day 222)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30104117MMR-161 Study Group. Immunogenicity and safety of measles-mumps-rubella vaccine at two different potency levels administered to healthy children aged 12-15 months: A phase III, randomized, non-inferiority trial. Vaccine. 2018 Sep 11;36(38):5781-5788. doi: 10.1016/j.vaccine.2018.07.076. Epub 2018 Aug 10.
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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
81 sites in 7 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 Measles and Mumps, run by GlaxoSmithKline at 81 sites in 7 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 20 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 81 sites in United States, Czechia, Spain, Finland, Thailand and 2 more countries. 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 17 Aug 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 (by Enzyme-linked Immunosorbent Assay [ELISA]) (time frame: At Day 42). The study lists 8 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 NCT01681992, 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.