NCT02058563 is a Phase 3 clinical trial of Priorix® in Rubella, sponsored by GlaxoSmithKline.

Who is sponsoring NCT02058563?

NCT02058563 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT02058563?

Interventions in NCT02058563: Priorix®, Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine.

What condition does NCT02058563 study?

NCT02058563 studies Rubella, Mumps, Measles.

Is NCT02058563 still recruiting?

NCT02058563 is currently completed. Last updated 6 June 2018.

Are results published for NCT02058563?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-06 · How we verify

NCT02058563

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older

Completed Phase 3 Results posted Last updated 6 June 2018

What this trial tests

Phase 3 trial testing Priorix® in Rubella in 996 participants. Completed in 17 September 2015.

Timeline

1 July 2014

Primary endpoint
24 May 2015

17 September 2015

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	prevention
Enrollment	996
Start date	1 July 2014
Primary completion	24 May 2015
Estimated completion	17 September 2015
Sites	17 locations across Slovakia, Estonia, United States

Drugs / interventions tested

Priorix®
Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine — full drug profile →

Conditions studied

Rubella — all drugs for Rubella →
Mumps — all drugs for Mumps →
Measles — all drugs for Measles →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

7 and older, any sex, with Rubella or Mumps. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Anti-measles Virus Antibody Concentrations. Primary · At Day 42

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.

Group	Value	95% CI
INV_MMR Group	1795.6	1641.1 – 1964.7
COM_MMR Group	1783.3	1624.6 – 1957.4

Anti-mumps Virus Antibody Concentrations Primary · At Day 42

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

Group	Value	95% CI
INV_MMR Group	110.6	102.1 – 119.8
COM_MMR Group	110.2	101.9 – 119.2

Anti-rubella Virus Antibody Concentrations. Primary · At Day 42

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

Group	Value	95% CI
INV_MMR Group	75.3	70.3 – 80.6
COM_MMR Group	75.6	70.8 – 80.7

Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate) Secondary · At Day 42

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.

Group	Value	95% CI
INV_MMR Group	428
COM_MMR Group	432

Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate). Secondary · At Day 42

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.

Group	Value	95% CI
INV_MMR Group	426
COM_MMR Group	434

Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate). Secondary · At Day 42

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.

Group	Value	95% CI
INV_MMR Group	431
COM_MMR Group	435

Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations. Secondary · At Day 42

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.

Anti-measles

Group	Value	95% CI
INV_MMR Group	42
COM_MMR Group	48

Anti-mumps

Group	Value	95% CI
INV_MMR Group	152
COM_MMR Group	128

Anti-rubella

Group	Value	95% CI
INV_MMR Group	179
COM_MMR Group	161

Number of Subjects With Solicited Local Symptoms Secondary · During the 4-day (Days 0-3) post-vaccination period

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.

Any injection site redness

Group	Value	95% CI
INV_MMR Group	53
COM_MMR Group	52

Grade 3 injection site redness

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	0

Any injection site swelling

Group	Value	95% CI
INV_MMR Group	23
COM_MMR Group	29

Grade 3 injection site swelling

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	0

Any injection site pain

Group	Value	95% CI
INV_MMR Group	51
COM_MMR Group	51

Grade 3 injection site pain

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	0

Number of Subjects Reporting Fever Secondary · During the 43 days (Days 0-42) post-vaccination period.

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.

Any

Group	Value	95% CI
INV_MMR Group	13
COM_MMR Group	23

Grade 3

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	6

Group	Value	95% CI
INV_MMR Group	2
COM_MMR Group	6

Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Secondary · During the 43 days (Days 0-42) post-vaccination period.

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 a

Any parotid/salivary gland swelling

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	1

Grade 3 parotid/salivary gland swelling

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	0

Related parotid/salivary gland swelling

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	0

Any meningism/seizure

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	1

Grade 3 meningism/seizure

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	0

Related meningism/seizure

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	0

Number of Subjects Reporting Unsolicited AEs Secondary · During the 43 days (Days 0-42) post-vaccination period.

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

Group	Value	95% CI
INV_MMR Group	95
COM_MMR Group	82

Number of Subjects Reporting Solicited Rash Symptom Secondary · During the 43 days (Days 0-42) post-vaccination period.

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.

Any

Group	Value	95% CI
INV_MMR Group	9
COM_MMR Group	5

Grade 3

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	0

Group	Value	95% CI
INV_MMR Group	6
COM_MMR Group	2

Localized rash

Group	Value	95% CI
INV_MMR Group	8
COM_MMR Group	3

Generalized rash

Group	Value	95% CI
INV_MMR Group	1
COM_MMR Group	2

Rash type - measles/rubella-rash

Group	Value	95% CI
INV_MMR Group	0
COM_MMR Group	2

Rash type - others

Group	Value	95% CI
INV_MMR Group	9
COM_MMR Group	3

Adverse events — posted to ClinicalTrials.gov

Time frame: 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. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

INV_MMR Group

Serious: 3/454 (1%)

Deaths: —

COM_MMR Group

Serious: 7/457 (2%)

Deaths: —

Serious adverse events (10 terms)

Reaction	System	INV_MMR Group	COM_MMR Group
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain lower	Gastrointestinal disorders	—	—
Pancreatitis relapsing	Gastrointestinal disorders	—	—
Biliary colic	Hepatobiliary disorders	—	—
Pyelonephritis	Infections and infestations	—	—
Jaw fracture	Injury, poisoning and procedural complications	—	—
Tendon injury	Injury, poisoning and procedural complications	—	—
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—
Psychogenic seizure	Psychiatric disorders	—	—

Other adverse events (4 terms — click to expand)

Reaction	System	INV_MMR Group	COM_MMR Group
Injection site erythema	General disorders	—	—
Vaccination site pain	General disorders	—	—
Injection site swelling	General disorders	—	—
Pyrexia	General disorders	—	—

Most-reported serious reactions: Abortion spontaneous, Abdominal pain, Abdominal pain lower, Pancreatitis relapsing, Biliary colic, Pyelonephritis, Jaw fracture, Tendon injury.

Data from ClinicalTrials.gov NCT02058563 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Priorix®

Trials testing the same drug.

NCT02861586 — Phase II Study to Evaluate Safety and Immunogenicity of a Chikungunya Vaccine · Phase 2 · completed

Other recruiting trials for Rubella

Currently open trials in the same condition.

NCT07358910 — Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective · recruiting

Other GlaxoSmithKline trials

Trials by the same sponsor.

NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02058563 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 6 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02058563.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing