A Phase 3 interventional study of Priorix and M-M-R II in Measles, Mumps and Rubella, sponsored by GlaxoSmithKline. Completed at 81 sites in 7 countries. Open to participants aged 12 Months to 15 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-07.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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).
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.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 4,538 is above the median of 852 across 105 interventional studies indexed under Measles.
Browse Measles studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 118 are open to participants now.
Of its 264 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For US children only:
Exclusion Criteria:
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 , 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:
For US children only:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13
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.
Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13
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.
Biological: M-M-R II · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13
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.
Also known as: GSK Biologicals' live attenuated measles, mumps, rubella 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.
Also known as: Merck & Co., Inc.'s measles, mumps, rubella 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.
Also known as: Merck & Co., Inc.'s varicella virus vaccine, live
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.
Also known as: GSK Biologicals' hepatitis A vaccine, inactivated
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.
Also known as: Pfizer Inc.'s pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 42
Anti-measles Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
Time frame: At Day 42
Anti-mumps Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in EU/mL.
Time frame: At Day 42
Anti-mumps Virus Antibody Concentrations (by PRNT)
Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
Time frame: At Day 42
Anti-rubella Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in IU/mL.
Time frame: At Day 42
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.
Time frame: 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.
Time frame: 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.
Time frame: At Day 84
Anti-measles Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in mIU/mL.
Time frame: At Day 84
Anti-mumps Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in EU/mL.
Time frame: At Day 84
Anti-rubella Virus Antibody Concentrations (by ELISA)
Antibody concentrations were expressed as GMCs in IU/mL.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From Day 0 through the end of the study (Day 222)
US sub-cohort: Subjects recruited in US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with Varivax (VV), Havrix (HAV) and Prevnar 13 (PCV-13) at Day 0. Non-US sub-cohort: Subjects recruited outside US and received Inv_MMR_Min or Inv_MMR_Med or Com_MMR (Lot 1 or 2) co-administered with VV and HAV at Day 0.
| Milestone | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Started | 1493 | 1497 | 1526 |
| Completed | 1427 | 1427 | 1443 |
| Not completed | 66 | 70 | 83 |
| Withdrew: Adverse event | 3 | 2 | 3 |
| Withdrew: Lost to follow-up | 36 | 38 | 53 |
| Withdrew: As per sponsor decision | 0 | 0 | 1 |
| Withdrew: Protocol violation | 0 | 0 | 1 |
| Withdrew: Withdrawal by subject | 27 | 30 | 25 |
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 | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-measles ≥ 150 mIU/mL | 90.9 (89.0 to 92.6) | 94.3 (92.7 to 95.6) | 96.5 (95.2 to 97.5) |
| Anti-measles ≥ 200 mIU/mL | 90.8 (88.9 to 92.5) | 94.2 (92.6 to 95.5) | 96.3 (95.0 to 97.3) |
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 | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-mumps ≥ 5 EU/mL | 99.1 (98.2 to 99.6) | 99.0 (98.1 to 99.6) | 99.2 (98.4 to 99.7) |
| Anti-mumps ≥ 10 EU/mL | 97.4 (96.2 to 98.3) | 97.3 (96.0 to 98.2) | 97.8 (96.7 to 98.7) |
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 | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| ≥ 2.5 ED50 | 79.1 (76.7 to 81.3) | 81.6 (79.3 to 83.7) | 87.5 (85.6 to 89.2) |
| ≥ 4 ED50 | 71.2 (68.6 to 73.7) | 73.4 (70.8 to 75.8) | 80.6 (78.3 to 82.7) |
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.
| Percentage of subjects | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| ≥ 4 IU/mL | 99.3 (98.6 to 99.7) | 99.5 (98.9 to 99.8) | 99.5 (98.9 to 99.8) |
| ≥ 10 IU/mL | 96.8 (95.5 to 97.7) | 97.3 (96.1 to 98.2) | 98.5 (97.6 to 99.1) |
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL.
| mIU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-measles Virus Antibody Concentrations (by ELISA) | 2209.9 (2041.3 to 2392.4) | 2540.9 (2368.8 to 2725.5) | 2787.7 (2619.5 to 2966.7) |
Antibody concentrations were expressed as GMCs in EU/mL.
| EU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations (by ELISA) | 58.7 (55.5 to 62.1) | 60.2 (56.8 to 63.7) | 71.6 (67.7 to 75.8) |
Antibody concentrations were expressed as Geometric Mean Titers (GMTs).
| Titers | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations (by PRNT) | 9.8 (9.0 to 10.6) | 10.7 (9.9 to 11.5) | 16.3 (15.1 to 17.7) |
Antibody concentrations were expressed as GMCs in IU/mL.
| IU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-rubella Virus Antibody Concentrations (by ELISA) | 57.0 (54.1 to 60.0) | 56.9 (54.2 to 59.8) | 64.4 (61.4 to 67.5) |
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.
| Percentage of subjects | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| ≥ 150 mIU/mL | 99.6 (97.7 to 100) | 98.8 (96.6 to 99.8) | 98.8 (96.6 to 99.8) |
| ≥ 200 mIU/mL | 99.6 (97.7 to 100) | 98.4 (96.1 to 99.6) | 98.4 (96.1 to 99.6) |
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.
| Percentage of subjects | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| ≥ 5 EU/mL | 99.1 (96.7 to 99.9) | 100 (98.2 to 100) | 99.1 (96.6 to 99.9) |
| ≥ 10 EU/mL | 99.1 (96.7 to 99.9) | 100 (98.2 to 100) | 98.6 (95.9 to 99.7) |
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.
| Percentage of subjects | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| ≥ 4 IU/mL | 100 (98.5 to 100) | 100 (98.6 to 100) | 100 (98.6 to 100) |
| ≥ 10 IU/mL | 99.6 (97.7 to 100) | 99.6 (97.9 to 100) | 99.6 (97.8 to 100) |
Antibody concentrations were expressed as GMCs in mIU/mL.
| mIU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-measles Virus Antibody Concentrations (by ELISA) | 4803.5 (4290.4 to 5378.0) | 4557.7 (4061.5 to 5114.4) | 4453.9 (3951.9 to 5019.8) |
Antibody concentrations were expressed as GMCs in EU/mL.
| EU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-mumps Virus Antibody Concentrations (by ELISA) | 88.9 (80.4 to 98.3) | 94.1 (85.3 to 103.8) | 86.4 (77.4 to 96.5) |
Antibody concentrations were expressed as GMCs in IU/mL.
| IU/mL | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Anti-rubella Virus Antibody Concentrations (by ELISA) | 112.7 (104.1 to 122.0) | 110.7 (102.9 to 119.1) | 110.9 (101.8 to 120.8) |
Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any pain | 261 | 262 | 301 |
| Any redness | 232 | 256 | 286 |
| Any swelling | 89 | 97 | 122 |
Assessed solicited local AEs were pain, redness and swelling. Any = Occurrence of the AE regardless of intensity grade or relation to vaccination.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any pain | 170 | 183 | 196 |
| Any redness | 159 | 196 | 217 |
| Any swelling | 67 | 91 | 96 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any drowsiness | 551 | 565 | 582 |
| Any irritability / fussiness | 749 | 792 | 788 |
| Any loss of appetite | 570 | 589 | 591 |
Any fever = Fever (axillary) ≥ 38°C.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Number of Subjects Reporting Any Fever Post Dose 1 | 582 | 617 | 618 |
Any fever = Fever (axillary) ≥ 38°C.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Number of Subjects Reporting Any Fever Post Dose 2 | 458 | 471 | 499 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any localized or generalized | 328 | 322 | 333 |
| Any with fever | 115 | 133 | 131 |
| Any varicella like | 57 | 53 | 45 |
| Any measles/rubella like | 53 | 61 | 68 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any localized or generalized | 129 | 150 | 141 |
| Any with fever | 52 | 63 | 53 |
| Any varicella like | 0 | 0 | 1 |
| Any measles/rubella like | 22 | 14 | 14 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any parotid gland swelling | 3 | 2 | 3 |
| Any febrile convulsion | 3 | 4 | 3 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any parotid gland swelling | 1 | 2 | 0 |
| Any febrile convulsion | 2 | 6 | 4 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Number of Subjects Reporting Any Unsolicited AES Post Dose 1 | 762 | 794 | 777 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Number of Subjects Reporting Any Unsolicited AES Post Dose 2 | 667 | 703 | 690 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Any NOCD | 35 | 39 | 33 |
| Any AE prompting ER visit | 348 | 361 | 347 |
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.
| Participants | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 91 | 102 | 92 |
Collected over Solicited local & general AEs: During the 4-day (Days 0-3) and 15-day (Days 0-14) post-vaccination period, respectively; Unsolicited AEs: During the 43-day (Days 0-42) post-vaccination period; SAEs: From Day 0 through the end of the study (Day 222).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inv_MMR_Min Group | 1/1,493 (0.1%) | 91/1,493 (6.1%) | 1,299/1,493 (87%) |
| Inv_MMR_Med Group | 0/1,497 (0%) | 102/1,497 (6.8%) | 1,311/1,497 (87.6%) |
| Com_MMR Group | 1/1,526 (0.1%) | 92/1,526 (6%) | 1,330/1,526 (87.2%) |
| Event | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| GastroenteritisInfections and infestations | 16/1493 | 19/1497 | 10/1526 |
| PneumoniaInfections and infestations | 7/1493 | 14/1497 | 10/1526 |
| Febrile convulsionNervous system disorders | 7/1493 | 13/1497 | 8/1526 |
| BronchitisInfections and infestations | 4/1493 | 10/1497 | 8/1526 |
| BronchiolitisInfections and infestations | 6/1493 | 7/1497 | 2/1526 |
| DehydrationMetabolism and nutrition disorders | 4/1493 | 7/1497 | 6/1526 |
| Gastroenteritis rotavirusInfections and infestations | 6/1493 | 3/1497 | 7/1526 |
| Pneumonia viralInfections and infestations | 2/1493 | 6/1497 | 1/1526 |
| PharyngotonsillitisInfections and infestations | 2/1493 | 5/1497 | 1/1526 |
| PyrexiaGeneral disorders | 1/1493 | 4/1497 | 1/1526 |
| Event | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group |
|---|---|---|---|
| IrritabilityPsychiatric disorders | 757/1493 | 795/1497 | 793/1526 |
| Decreased appetiteMetabolism and nutrition disorders | 571/1493 | 593/1497 | 593/1526 |
| SomnolenceNervous system disorders | 551/1493 | 567/1497 | 582/1526 |
| PainGeneral disorders | 334/1493 | 336/1497 | 378/1526 |
| Upper respiratory tract infectionInfections and infestations | 350/1493 | 354/1497 | 365/1526 |
| ErythemaSkin and subcutaneous tissue disorders | 288/1493 | 331/1497 | 362/1526 |
| NasopharyngitisInfections and infestations | 148/1493 | 176/1497 | 134/1526 |
| SwellingGeneral disorders | 123/1493 | 152/1497 | 170/1526 |
| Otitis mediaInfections and infestations | 95/1493 | 99/1497 | 116/1526 |
| BronchitisInfections and infestations | 81/1493 | 96/1497 | 77/1526 |
| Age, Continuous(Months) | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group | Total |
|---|---|---|---|---|
| Mean | 12.6 ± 0.9 | 12.6 ± 0.9 | 12.6 ± 0.9 | 12.6 ± 0.9 |
| Sex: Female, Male(Participants) | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group | Total |
|---|---|---|---|---|
| Female | 704 | 718 | 758 | 2180 |
| Male | 789 | 779 | 768 | 2336 |
| Race/Ethnicity, Customized(Participants) | Inv_MMR_Min Group | Inv_MMR_Med Group | Com_MMR Group | Total |
|---|---|---|---|---|
| African Heritage / African American | 45 | 53 | 46 | 144 |
| American Indian or Alaskan Native | 2 | 1 | 1 | 4 |
| Asian - Central/South Asian Heritage | 1 | 0 | 2 | 3 |
| Asian - East Asian Heritage | 3 | 0 | 1 | 4 |
| Asian - South East Asian Heritage | 362 | 366 | 367 | 1095 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 1 |
| White - Arabic / North African Heritage | 8 | 8 | 8 | 24 |
| White - Caucasian / European Heritage | 1017 | 1022 | 1052 | 3091 |
| Other | 55 | 46 | 49 | 150 |
Ran from Oct 2012 to primary completion in Feb 2015, 27 months.
Results were first posted in Aug 2018, 3 years 6 months after primary completion. A results delay was requested in Apr 2016.
Of 16 phase 3 interventional studies under Measles, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 24. This study's 27 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Measles-Mumps-Rubella Vaccine