A Phase 3 interventional study of Priorix and M-M-R II in Measles; Mumps; Rubella and Measles-Mumps-Rubella Vaccine, sponsored by GlaxoSmithKline. Completed at 95 sites in 5 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 the immunogenicity and safety of GSK Biologicals' trivalent MMR (Priorix), comparing it to Merck's MMR vaccine (M-M-R II), which is approved for use in the US in healthy children 12 to 15 months of age.
This study will evaluate the safety of GSK's trivalent MMR vaccine (referred to as INV_MMR vaccine) at a potency that will be used to define maximum release limits for the INV_MMR in comparison to the US standard of care (M-M-R II/ M-M-R VaxPro vaccine referred to as COM_MMR vaccine). In order to obtain more representative data on the comparator vaccine, the COM_MMR used in this study will consist of two lots designated COM_MMR_L1 and COM_MMR_L2. Throughout the study COM_MMR_L1 and COM_MMR_L2 will be analyzed as pooled lots. This study is intended to support licensure of GSK's MMR vaccine in the US.
All children will receive Varivax and Havrix vaccines, concomitantly with MMR containing vaccine at 12 to 15 months of age. Prevnar 13 will be administered only to US children. At the end of the study, GSK will provide a second dose of Havrix and/or varicella vaccine to participants enrolled in selected non-US countries if local health departments do not routinely provide hepatitis A and varicella vaccination. The second dose of Havrix and varicella vaccine is not part of the study procedures.
134 studies on the registry are indexed under Measles; 17 are open to participants now.
This study's enrollment of 1,742 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.
Exclusion Criteria:
Chronic administration (defined as 14 or more consecutive days) of , or other immune-modifying drugs during the period starting 180 days prior to the study vaccination at Visit 1 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 the day of study vaccination at Visit 1 and ending at Visit 2. Please Note:
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.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
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 1 dose of the study vaccine Priorix co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
Biological: Priorix · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13
Subjects receive 1 dose of the licensed vaccine M-M-R II or M-M-R VaxPro Lot 1 or Lot 2 co-administered with Varivax and Havrix vaccines at Day 0. Subjects recruited in the US also receive Prevnar 13 at Day 0.
Biological: M-M-R II · Biological: Varivax · Biological: Havrix · Biological: Prevnar 13
1 dose administered subcutaneously in the triceps region of left arm at Day 0
Also known as: GSK Biologicals' live attenuated measles, mumps and rubella (MMR) vaccine
1 dose administered subcutaneously in the triceps region of left arm at Day 0
Also known as: MMR vaccine live (M-M R II, Merck & Co., Inc., or M-M-R VaxPro, Sanofi Pasteur/Merck Sharp and Dohme [SPMSD])
1 dose administered subcutaneously in the triceps region of right arm at Day 0
Also known as: Merck & Co. Inc.'s Varicella virus vaccine, live
1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
Also known as: GSK Biologicals' Hepatitis A vaccine, inactivated
1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
Also known as: Pfizer Inc.'s Pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein)
Number of Subjects Reporting Fever After MMR (Priorix or M-M-R II/M-M-R VaxPro [Lot 1 or Lot 2]) Vaccination
Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.
Time frame: During Day 5 to Day 12 post-vaccination period
Percentage of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to \[≥\] 200 milli International Units per milliliter \[mIU/mL\] (Enzyme-Linked Immunosorbent Assay \[ELISA\], Enzygnost) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before vaccination.
Time frame: At Day 42 post vaccination
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
Percentage of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter \[EU/mL\] (ELISA, Pharmaceutical Product Development, Inc.\[PPD\]) among subjects who were seronegative (antibody concentration \< 5 EU/mL) before vaccination.
Time frame: At Day 42 post vaccination
Anti-mumps Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
Percentage of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter \[IU/mL\] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration \< 4 IU/mL) before vaccination.
Time frame: At Day 42 post vaccination
Anti-rubella Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
Time frame: At Day 42 post vaccination
Number of Subjects With Any Solicited Local Adverse Events (AEs)
Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of 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
Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of 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
Any fever (≥ 38°C) = Occurrence of fever 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
Any rash = Occurrence of 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 MMR Specific Solicited General AEs
Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of 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
Unsolicited AE included any AE 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 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 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: Day 0 through the end of the study (Day 180)
Number of Subjects Reporting Any Serious Adverse Events (SAEs)
SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
Time frame: Day 0 through the end of the study (Day 180)
Number of Subjects Reporting Measles-like Illness
Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis: maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.
Time frame: During Day 5 to Day 12 post-vaccination period
6 subjects from 1742 were allocated subject number but no study vaccine was administered. Therefore, the number of subjects started in 1736.
| Milestone | INV_MMR | COM_MMR |
|---|---|---|
| Started | 1164 | 572 |
| Completed | 1117 | 542 |
| Not completed | 47 | 30 |
| Withdrew: Lost to follow-up | 29 | 21 |
| Withdrew: Family out of country until 9/29/2015 | 1 | 0 |
| Withdrew: Loss of kaiser insurance | 1 | 0 |
| Withdrew: 2nd blooddraw & diary card incomplete | 1 | 0 |
| Withdrew: Traveling outside the country | 1 | 0 |
| Withdrew: Withdrawal by subject | 14 | 9 |
Fever was assessed for temperature equal to/above (≥) 38.0°C and above (\>) 39.0°C. The safety profile for fever was assessed based on the group difference (INV_MMR minus COM_MMR) in incidence of fever equal to or below the cut-off value.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| > 39.0°C | 47 | 17 |
| ≥ 38.0°C | 205 | 95 |
Seroresponse was defined as post-vaccination anti-measles virus antibody concentration greater than or equal to \[≥\] 200 milli International Units per milliliter \[mIU/mL\] (Enzyme-Linked Immunosorbent Assay \[ELISA\], Enzygnost) among subjects who were seronegative (antibody concentration less than \[\<\] 150 mIU/mL) before vaccination.
| Percentage of subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| ≥ 150 mIU/mL | 99.3 (98.6 to 99.7) | 96.7 (94.8 to 98.1) |
| ≥ 200 mIU/mL | 99.0 (98.2 to 99.5) | 96.5 (94.6 to 97.9) |
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analyses included initially seronegative subjects only.
| mIU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-measles Virus Antibody Concentrations | 2751.9 (2618.3 to 2892.2) | 3133.3 (2878.6 to 3410.6) |
Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Unit per milliliter \[EU/mL\] (ELISA, Pharmaceutical Product Development, Inc.\[PPD\]) among subjects who were seronegative (antibody concentration \< 5 EU/mL) before vaccination.
| Percentage of subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| ≥ 5 EU/mL | 99.8 (99.3 to 100) | 99.4 (98.2 to 99.9) |
| ≥ 10 EU/mL | 99.4 (98.7 to 99.8) | 97.9 (96.2 to 99.0) |
Antibody concentrations were expressed as GMCs in EU/mL. Analyses included initially seronegative subjects only.
| EU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-mumps Virus Antibody Concentrations | 86.0 (82.0 to 90.3) | 82.6 (76.5 to 89.2) |
Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Unit per milliliter \[IU/mL\] (ELISA, Enzygnost) among subjects who were seronegative (antibody concentration \< 4 IU/mL) before vaccination.
| Percentage of subjects | INV_MMR Group | COM_MMR Group |
|---|---|---|
| ≥4 IU/mL | 99.6 (99.0 to 99.9) | 99.8 (98.9 to 100) |
| ≥10 IU/mL | 95.7 (94.3 to 96.8) | 98.3 (96.7 to 99.2) |
Antibody concentrations were expressed as GMCs in IU/mL. Analyses included initially seronegative subjects only.
| IU/mL | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Anti-rubella Virus Antibody Concentrations | 45.0 (42.8 to 47.2) | 66.8 (62.3 to 71.7) |
Assessed solicited local AEs were injection site pain, redness and swelling. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any pain | 312 | 131 |
| Any redness (mm) | 260 | 137 |
| Any swelling (mm) | 96 | 58 |
Assessed solicited general AEs were drowsiness, irritability/fussiness and loss of appetite. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any drowsiness | 527 | 238 |
| Any irritability/fussiness | 722 | 345 |
| Any loss of appetite | 493 | 232 |
Any fever (≥ 38°C) = Occurrence of fever regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting Any Fever | 350 | 179 |
Any rash = Occurrence of AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any localized or generalized | 275 | 152 |
| Any with fever | 100 | 48 |
| Any varicella like | 40 | 22 |
| Any measles/rubella like | 65 | 26 |
Assessed MMR specific solicited general AEs were parotid gland swelling and any suspected signs of meningism including febrile convulsions. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Any parotid gland swelling | 0 | 0 |
| Any febrile convulsion | 2 | 0 |
Unsolicited AE included any AE 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 AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Number of Subjects Reporting Any Unsolicited AEs | 598 | 277 |
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 Group | COM_MMR Group |
|---|---|---|
| NOCDs | 29 | 11 |
| AEs prompting ER visits | 166 | 55 |
SAE included any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization or resulted in disability/incapacity. Any = Occurrence of AE regardless of intensity grade or relation to vaccination.
| Participants | INV_MMR | COM_MMR |
|---|---|---|
| Number of Subjects Reporting Any Serious Adverse Events (SAEs) | 24 | 9 |
Measles-like illness was defined as the occurrence of the following signs/symptoms in the absence of another confirmed diagnosis: maculopapular rash (includes measles/rubella-like rash), fever (≥ 38°C) and at least one of the symptoms: cough, coryza (runny nose), conjunctivitis or diarrhea, with fever or rash. Other event must be one of cough, coryza, conjunctivitis, or diarrhea.
| Participants | INV_MMR Group | COM_MMR Group |
|---|---|---|
| Measles-like illness | 18 | 5 |
| Maculopapular rash plus fever and one other event | 26 | 9 |
| Maculopapular rash and fever | 90 | 43 |
Collected over SAEs = From Day 0 to study end (Day 180); Solicited local and general AEs = During the 4-day (Day 0-3) and 15-day (Day 0-14) post vaccination period, respectively; Unsolicited adverse events = During the 43-day (Day 0-42) post vaccination period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INV_MMR Group | 0/1,164 (0%) | 24/1,164 (2.1%) | 980/1,164 (84.2%) |
| COM_MMR Group | 0/572 (0%) | 9/572 (1.6%) | 477/572 (83.4%) |
| Event | INV_MMR Group | COM_MMR Group |
|---|---|---|
| BronchitisInfections and infestations | 1/1164 | 2/572 |
| PneumoniaInfections and infestations | 4/1164 | 1/572 |
| DehydrationMetabolism and nutrition disorders | 3/1164 | 0/572 |
| Immune thrombocytopenic purpuraBlood and lymphatic system disorders | 0/1164 | 1/572 |
| GastritisGastrointestinal disorders | 0/1164 | 1/572 |
| Bacterial infectionInfections and infestations | 0/1164 | 1/572 |
| BronchiolitisInfections and infestations | 1/1164 | 1/572 |
| Fungal skin infectionInfections and infestations | 0/1164 | 1/572 |
| InfluenzaInfections and infestations | 0/1164 | 1/572 |
| Bronchial hyperreactivityRespiratory, thoracic and mediastinal disorders | 0/1164 | 1/572 |
| Event | INV_MMR Group | COM_MMR Group |
|---|---|---|
| IrritabilityPsychiatric disorders | 723/1164 | 348/572 |
| SomnolenceNervous system disorders | 529/1164 | 238/572 |
| Decreased appetiteMetabolism and nutrition disorders | 495/1164 | 233/572 |
| PyrexiaGeneral disorders | 350/1164 | 180/572 |
| Injection site painGeneral disorders | 313/1164 | 133/572 |
| RashSkin and subcutaneous tissue disorders | 275/1164 | 152/572 |
| Injection site erythemaGeneral disorders | 284/1164 | 143/572 |
| Upper respiratory tract infectionInfections and infestations | 111/1164 | 73/572 |
| Injection site swellingGeneral disorders | 105/1164 | 61/572 |
| DiarrhoeaGastrointestinal disorders | 95/1164 | 46/572 |
| Age, Continuous(Months) | INV_MMR | COM_MMR | Total |
|---|---|---|---|
| Mean | 12.3 ± 0.7 | 12.3 ± 0.7 | 12.3 ± 0.7 |
| Sex: Female, Male(Participants) | INV_MMR | COM_MMR | Total |
|---|---|---|---|
| Female | 551 | 270 | 821 |
| Male | 613 | 302 | 915 |
| Race/Ethnicity, Customized(Participants) | INV_MMR | COM_MMR | Total |
|---|---|---|---|
| African Heritage / African American | 64 | 38 | 102 |
| American Indian or Alaskan Native | 29 | 16 | 45 |
| Asian - Central/South Asian Heritage | 9 | 4 | 13 |
| Asian - East Asian Heritage | 131 | 65 | 196 |
| Asian - Japanese Heritage | 2 | 0 | 2 |
| Asian - South East Asian Heritage | 28 | 12 | 40 |
| Native Hawaiian or Other Pacific Islander | 1 | 2 | 3 |
| White - Arabic / North African Heritage | 3 | 3 | 6 |
| White - Caucasian / European Heritage | 808 | 385 | 1193 |
| Other | 89 | 47 | 136 |
This study is completed, as verified in Dec 2020. 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