A Phase 3 interventional study of Priorix® and Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine in Rubella, Mumps and Measles, sponsored by GlaxoSmithKline. Completed at 17 sites in 3 countries. Open to participants aged 7 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-06.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
The purpose of this study is to evaluate the immunogenicity and safety of GSK's trivalent MMR (Priorix®), comparing it to Merck"s MMR vaccine (M-M-R®II), which is approved for use in the US.
This study will evaluate the immunogenicity of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) in contrast to the US standard of care (M-M-R®II, Merck and Company, referred to as COM_MMR) when both are used as a second dose in subjects 7 years of age and older. In this study, the INV_MMR vaccine may be administered as a second dose to persons with either a history or formal documentation of at least one dose immunization with any MMR vaccine. This study is intended to support licensure of GSK's MMR vaccine in the US.
85 studies on the registry are indexed under Rubella; 11 are open to participants now.
This study's enrollment of 996 is above the median of 801 across 71 interventional studies indexed under Rubella.
Browse Rubella 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 all children 7-17 years of age:
For all adults 18 years of age and older:
Female subjects of non- may be enrolled in the study.
Female subjects of childbearing potential may be enrolled in the study, if the subject
Exclusion Criteria:
For all children 7-17 years of age:
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
Subjects will receive 1 dose of GSK Biologicals' trivalent Measles, Mumps, and Rubella Virus Vaccine (Priorix®).
Biological: Priorix®
Subjects will receive 1 dose of Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.
Biological: Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine
1 dose administered as a subcutaneous (SC) injection.
1 dose administered subcutaneously.
Anti-measles Virus Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
Time frame: At Day 42
Anti-mumps Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL
Time frame: At Day 42
Anti-rubella Virus Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL
Time frame: At Day 42
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)
Seroresponse was defined as: Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
Time frame: At Day 42
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).
Seroresponse was defined as: Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
Time frame: At Day 42
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).
Seroresponse was defined as: Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
Time frame: At Day 42
Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations.
For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.
Time frame: At Day 42
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter \>50mm. Grade 3 swelling = swelling with surface diameter \>50mm.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects Reporting Fever
Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever \>39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.
Time frame: During the 43 days (Days 0-42) post-vaccination period.
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure.
Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 43 days (Days 0-42) post-vaccination period.
Number of Subjects Reporting Unsolicited AEs
Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Time frame: During the 43 days (Days 0-42) post-vaccination period.
Number of Subjects Reporting Solicited Rash Symptom
Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 43 days (Days 0-42) post-vaccination period.
Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis)
Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 43 days (Days 0-42) post-vaccination period.
Number of Subjects Reporting NOCDs
Occurrence of new onset chronic diseases (NOCDs)
Time frame: Day 0 through the end of the study (Day 180)
Number of Subjects Reporting Adverse Events Prompting ER Visits
Occurrence of AEs prompting emergency room (ER) visits.
Time frame: Day 0 through the end of the study (Day 180)
Number of Subjects Reporting Serious Adverse Events (SAEs)
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
Time frame: Day 0 through the end of the study (Day 180)
A total of 996 subjects were enrolled and 994 were vaccinated. Of the 994 vaccinated subjects, 83 subjects from 2 US sites were excluded due to significant GCP concerns, resulting in 911 subjects in the Total vaccinated cohort considered for the analysis.
| Milestone | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Started | 454 | 457 |
| Completed | 426 | 433 |
| Not completed | 28 | 24 |
| Withdrew: Lost to follow-up | 26 | 22 |
| Withdrew: Other (vaccinated later as new subject) | 1 | 0 |
| Withdrew: Consent withdrawal | 1 | 1 |
| Withdrew: Other (patient incarcerated) | 0 | 1 |
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in milli International Units per milliliter (mIU/mL). Seropositivity was defined as subjects with anti-measles virus antibody concentration equal or greater than 150 mIU/mL.
| mIU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-measles Virus Antibody Concentrations. | 1795.6 (1641.1 to 1964.7) | 1783.3 (1624.6 to 1957.4) |
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in EU/mL. Seropositivity was defined as subjects with anti-mumps virus antibody concentration equal or greater than 5 EU/mL
| EU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-mumps Virus Antibody Concentrations | 110.6 (102.1 to 119.8) | 110.2 (101.9 to 119.2) |
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. Seropositivity was defined as subjects with anti-rubella virus antibody concentration equal or greater than 4 IU/mL
| IU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-rubella Virus Antibody Concentrations. | 75.3 (70.3 to 80.6) | 75.6 (70.8 to 80.7) |
Seroresponse was defined as: Anti-measles virus antibody concentration equal to or above the threshold of 200 mIU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate) | 428 | 432 |
Seroresponse was defined as: Anti-mumps virus antibody concentration equal to or above the threshold of 10 EU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate). | 426 | 434 |
Seroresponse was defined as: Anti-rubella virus antibody concentration equal to or above the threshold of 10 IU/mL after administration of INV_MMR vaccine vs. COM_MMR at Day 42.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate). | 431 | 435 |
For subjects with seronegative status at pre-vaccination, a 4-fold rise in antibody concentration is defined as 4 times the cut-off level of the assay. Cut-off levels for anti-measles, anti-mumps and anti-rubella virus antibody concentrations are 150 mIU/mL, 5 EU/mL and 4 IU/mL.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-measles | 42 | 48 |
| Anti-mumps | 152 | 128 |
| Anti-rubella | 179 | 161 |
Assessed solicited local symptoms were pain, redness and swelling. Any = Occurrence of any local symptom regardless of their intensity grade. Grade 3 Pain = Significant pain at rest. Prevented normal every day activities. Grade 3 redness = redness with surface diameter \>50mm. Grade 3 swelling = swelling with surface diameter \>50mm.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any injection site redness | 53 | 52 |
| Grade 3 injection site redness | 0 | 0 |
| Any injection site swelling | 23 | 29 |
| Grade 3 injection site swelling | 0 | 0 |
| Any injection site pain | 51 | 51 |
| Grade 3 injection site pain | 1 | 0 |
Fever was assessed:Any fever (≥38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade3 fever = fever \>39.5°C. . Related = symptom assessed by the investigator as causally related to study vaccination.The preferred route for recording temperature in this study was oral.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any | 13 | 23 |
| Grade 3 | 1 | 6 |
| Related | 2 | 6 |
Assessed MMR specific symptoms were parotid/salivary gland swelling and any sign of meningism/seizure. Parotid/salivary gland swelling: Any = occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade 3 Parotid/salivary gland swelling = Swelling accompanied with general symptoms. Meningism/seizure: Any= occurrence of any general symptoms regardless of their intensity grade or relationship to vaccination; Grade-3 meningism/seizure= Prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related symptom = symptom assessed by the investigator as causally related to study vaccination.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any parotid/salivary gland swelling | 1 | 1 |
| Grade 3 parotid/salivary gland swelling | 1 | 0 |
| Related parotid/salivary gland swelling | 0 | 0 |
| Any meningism/seizure | 1 | 1 |
| Grade 3 meningism/seizure | 1 | 0 |
| Related meningism/seizure | 0 | 0 |
Any untoward medical occurrence in a patient or clinical investigation child, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting Unsolicited AEs | 95 | 82 |
Assessed any rash, Grade 3, Related, Localized rash, Generalized rash,measles/rubella-rash. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination. Grade3 rash/exanthema= Rash which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Grade 3 measles/rubella/varicella-like rash = Rash with more than150 lesions. Related = symptom assessed by the investigator as causally related to study vaccination.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any | 9 | 5 |
| Grade 3 | 0 | 0 |
| Related | 6 | 2 |
| Localized rash | 8 | 3 |
| Generalized rash | 1 | 2 |
| Rash type - measles/rubella-rash | 0 | 2 |
| Rash type - others | 9 | 3 |
Assessed any, Grade-3, Related. Any= occurrence of any general symptom regardless of its intensity grade or relationship to vaccination; Grade3 joint pain (arthralgia/arthritis)= Pain which prevented normal, everyday activities (In adults/adolescents, such an AE could, for example, prevented attendance at work/school and could necessitated the administration of corrective therapy). Related = symptom assessed by the investigator as causally related to study vaccination.
| subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any | 8 | 4 |
| Grade 3 | 0 | 0 |
| Related | 3 | 1 |
Occurrence of new onset chronic diseases (NOCDs)
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting NOCDs | 2 | 1 |
Occurrence of AEs prompting emergency room (ER) visits.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting Adverse Events Prompting ER Visits | 14 | 9 |
A serious adverse event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.
| Subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting Serious Adverse Events (SAEs) | 3 | 7 |
Collected over Serious Adverse Events: From Day 0 to Day 180, Solicited Local Adverse Events: From Day 0 to Day 3, Solicited General and Unsolicited Adverse Events: From Day 0 to Day 42. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INV_MMR Group | — | 3/454 (0.7%) | 93/454 (20.5%) |
| COM_MMR Group | — | 7/457 (1.5%) | 102/457 (22.3%) |
| Event | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Abortion spontaneousPregnancy, puerperium and perinatal conditions | 0/454 | 2/457 |
| Abdominal pain lowerGastrointestinal disorders | 1/454 | 0/457 |
| Biliary colicHepatobiliary disorders | 1/454 | 0/457 |
| Tendon injuryInjury, poisoning and procedural complications | 1/454 | 0/457 |
| Psychogenic seizurePsychiatric disorders | 1/454 | 0/457 |
| Abdominal painGastrointestinal disorders | 0/454 | 1/457 |
| Pancreatitis relapsingGastrointestinal disorders | 0/454 | 1/457 |
| PyelonephritisInfections and infestations | 0/454 | 1/457 |
| Jaw fractureInjury, poisoning and procedural complications | 0/454 | 1/457 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/454 | 1/457 |
| Event | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Injection site erythemaGeneral disorders | 53/454 | 52/457 |
| Vaccination site painGeneral disorders | 51/454 | 51/457 |
| Injection site swellingGeneral disorders | 23/454 | 29/457 |
| PyrexiaGeneral disorders | 13/454 | 23/457 |
| Age, Continuous(Months) | INV_MMR Group | COM_MMR Group | Total |
|---|---|---|---|
| Mean | 25.9 ± 13.9 | 25.6 ± 13.8 | 25.7 ± 13.8 |
| Sex: Female, Male(Participants) | INV_MMR Group | COM_MMR Group | Total |
|---|---|---|---|
| Female | 250 | 252 | 502 |
| Male | 204 | 205 | 409 |
| Race/Ethnicity, Customized(Participants) | INV_MMR Group | COM_MMR Group | Total |
|---|---|---|---|
| African Heritage/African American | 108 | 103 | 211 |
| American Indian or Alaskan native | 2 | 4 | 6 |
| Asian - Central/South Asian heritage | 1 | 0 | 1 |
| Asian - East Asian heritage | 1 | 0 | 1 |
| Asian - Japanese heritage | 0 | 1 | 1 |
| Asian - South East Asian heritage | 0 | 0 | 0 |
| Native Hawaiian or other Pacific Islander | 1 | 0 | 1 |
| White - Arabic/North African heritage | 0 | 1 | 1 |
| White - Caucasian/European heritage | 334 | 344 | 678 |
| Other | 7 | 4 | 11 |
This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Measles-Mumps-Rubella Vaccine