Trial Outcomes & Findings for Immunogenicity and Safety of GSK Biologicals' Combined Measles-mumps-rubella Vaccine in Volunteers, Seven Years of Age and Older (NCT NCT02058563)

NCT ID: NCT02058563

Last Updated: 2018-06-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 996 participants
• Primary outcome timeframe: At Day 42
• Results posted on: 2018-06-06

Participant Flow

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.

Participant milestones

Measure	INV_MMR Group Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group Subjects received one dose of COM\_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Study STARTED	454	457
Overall Study COMPLETED	426	433
Overall Study NOT COMPLETED	28	24

Reasons for withdrawal

Measure	INV_MMR Group Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group Subjects received one dose of COM\_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Overall Study Lost to Follow-up	26	22
Overall Study Other (vaccinated later as new subject)	1	0
Overall Study Consent Withdrawal	1	1
Overall Study Other (patient incarcerated)	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	INV_MMR Group n=454 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).	Total n=911 Participants Total of all reporting groups
Age, Continuous	25.9 Months STANDARD_DEVIATION 13.9 • n=5 Participants	25.6 Months STANDARD_DEVIATION 13.8 • n=7 Participants	25.7 Months STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	250 Participants n=5 Participants	252 Participants n=7 Participants	502 Participants n=5 Participants
Sex: Female, Male Male	204 Participants n=5 Participants	205 Participants n=7 Participants	409 Participants n=5 Participants
Race/Ethnicity, Customized African Heritage/African American	108 Participants n=5 Participants	103 Participants n=7 Participants	211 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaskan native	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Japanese heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian heritage	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Caucasian/European heritage	334 Participants n=5 Participants	344 Participants n=7 Participants	678 Participants n=5 Participants
Race/Ethnicity, Customized Other	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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.

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Anti-measles Virus Antibody Concentrations.	1795.6 mIU/mL Interval 1641.1 to 1964.7	1783.3 mIU/mL Interval 1624.6 to 1957.4

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Anti-mumps Virus Antibody Concentrations	110.6 EU/mL Interval 102.1 to 119.8	110.2 EU/mL Interval 101.9 to 119.2

PRIMARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Anti-rubella Virus Antibody Concentrations.	75.3 IU/mL Interval 70.3 to 80.6	75.6 IU/mL Interval 70.8 to 80.7

SECONDARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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.

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Threshold of 200 mIU/mL (Seroresponse Rate)	428 Subjects	432 Subjects

SECONDARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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.

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-mumps Virus Antibody Concentration Equal or Above the Threshold of 10 EU/mL (Seroresponse Rate).	426 Subjects	434 Subjects

SECONDARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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.

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=436 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Anti-rubella Virus Antibody Concentration Equal or Above the Threshold of 10 IU/mL (Seroresponse Rate).	431 Subjects	435 Subjects

SECONDARY outcome

Timeframe: At Day 42

Population: ATP cohort for immunogenicity: included all eligible subjects with post-dose serology results available for at least one antigen of measles, mumps, or rubella, who complied with the protocol, who did not meet any elimination criteria and had no intercurrent medical conditions leading to elimination up to the Visit 2 (Day 42) blood sample.

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.

Outcome measures

Measure	INV_MMR Group n=432 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=435 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations. Anti-measles	42 Subjects	48 Subjects
Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations. Anti-mumps	152 Subjects	128 Subjects
Number of Subjects Who Achieved a 4-fold or Greater Rise in Anti-measles, Anti-mumps and Anti-rubella Virus Antibody Concentrations. Anti-rubella	179 Subjects	161 Subjects

SECONDARY outcome

Timeframe: During the 4-day (Days 0-3) post-vaccination period

Population: Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.

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.

Outcome measures

Measure	INV_MMR Group n=433 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=445 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects With Solicited Local Symptoms Any injection site redness	53 Subjects	52 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 injection site redness	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any injection site swelling	23 Subjects	29 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 injection site swelling	0 Subjects	0 Subjects
Number of Subjects With Solicited Local Symptoms Any injection site pain	51 Subjects	51 Subjects
Number of Subjects With Solicited Local Symptoms Grade 3 injection site pain	1 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 43 days (Days 0-42) post-vaccination period.

Population: Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.

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.

Outcome measures

Measure	INV_MMR Group n=431 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=445 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Fever Any	13 Subjects	23 Subjects
Number of Subjects Reporting Fever Grade 3	1 Subjects	6 Subjects
Number of Subjects Reporting Fever Related	2 Subjects	6 Subjects

SECONDARY outcome

Timeframe: During the 43 days (Days 0-42) post-vaccination period.

Population: Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.

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.

Outcome measures

Measure	INV_MMR Group n=431 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=445 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Any parotid/salivary gland swelling	1 Subjects	1 Subjects
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Grade 3 parotid/salivary gland swelling	1 Subjects	0 Subjects
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Related parotid/salivary gland swelling	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Any meningism/seizure	1 Subjects	1 Subjects
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Grade 3 meningism/seizure	1 Subjects	0 Subjects
Number of Subjects Reporting Solicited General Symptoms as Parotid/Salivary Gland Swelling and Any Sign of Meningism/Seizure. Related meningism/seizure	0 Subjects	0 Subjects

SECONDARY outcome

Timeframe: During the 43 days (Days 0-42) post-vaccination period.

Population: Total Vaccinated cohort included all vaccinated subjects.

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

Outcome measures

Measure	INV_MMR Group n=454 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Unsolicited AEs	95 Subjects	82 Subjects

SECONDARY outcome

Timeframe: During the 43 days (Days 0-42) post-vaccination period.

Population: Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.

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.

Outcome measures

Measure	INV_MMR Group n=431 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=445 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Solicited Rash Symptom Related	6 Subjects	2 Subjects
Number of Subjects Reporting Solicited Rash Symptom Any	9 Subjects	5 Subjects
Number of Subjects Reporting Solicited Rash Symptom Grade 3	0 Subjects	0 Subjects
Number of Subjects Reporting Solicited Rash Symptom Localized rash	8 Subjects	3 Subjects
Number of Subjects Reporting Solicited Rash Symptom Generalized rash	1 Subjects	2 Subjects
Number of Subjects Reporting Solicited Rash Symptom Rash type - measles/rubella-rash	0 Subjects	2 Subjects
Number of Subjects Reporting Solicited Rash Symptom Rash type - others	9 Subjects	3 Subjects

SECONDARY outcome

Timeframe: During the 43 days (Days 0-42) post-vaccination period.

Population: Total Vaccinated cohort included all vaccinated subjects with a documented vaccine administration.

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.

Outcome measures

Measure	INV_MMR Group n=431 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=445 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis) Any	8 subjects	4 subjects
Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis) Grade 3	0 subjects	0 subjects
Number of Subjects Reporting Solicited Joint Pain (Arthralgia/Arthritis) Related	3 subjects	1 subjects

SECONDARY outcome

Timeframe: Day 0 through the end of the study (Day 180)

Population: Total Vaccinated cohort included all vaccinated subjects.

Occurrence of new onset chronic diseases (NOCDs)

Outcome measures

Measure	INV_MMR Group n=454 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting NOCDs	2 Subjects	1 Subjects

SECONDARY outcome

Timeframe: Day 0 through the end of the study (Day 180)

Population: Total Vaccinated cohort included all vaccinated subjects.

Occurrence of AEs prompting emergency room (ER) visits.

Outcome measures

Measure	INV_MMR Group n=454 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Adverse Events Prompting ER Visits	14 Subjects	9 Subjects

SECONDARY outcome

Timeframe: Day 0 through the end of the study (Day 180)

Population: Total Vaccinated cohort included all vaccinated subjects.

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.

Outcome measures

Measure	INV_MMR Group n=454 Participants Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 Participants Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Number of Subjects Reporting Serious Adverse Events (SAEs)	3 Subjects	7 Subjects

Adverse Events

INV_MMR Group

Serious events: 3 serious events

Other events: 93 other events

Deaths: 0 deaths

COM_MMR Group

Serious events: 7 serious events

Other events: 102 other events

Deaths: 0 deaths

Serious adverse events

Measure	INV_MMR Group n=454 participants at risk Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 participants at risk Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
Gastrointestinal disorders Abdominal pain	0.00% 0/454 • 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	0.22% 1/457 • Number of events 1 • 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
Gastrointestinal disorders Abdominal pain lower	0.22% 1/454 • Number of events 1 • 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	0.00% 0/457 • 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
Gastrointestinal disorders Pancreatitis relapsing	0.00% 0/454 • 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	0.22% 1/457 • Number of events 1 • 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
Hepatobiliary disorders Biliary colic	0.22% 1/454 • Number of events 1 • 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	0.00% 0/457 • 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
Infections and infestations Pyelonephritis	0.00% 0/454 • 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	0.22% 1/457 • Number of events 1 • 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
Injury, poisoning and procedural complications Jaw fracture	0.00% 0/454 • 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	0.22% 1/457 • Number of events 1 • 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
Injury, poisoning and procedural complications Tendon injury	0.22% 1/454 • Number of events 1 • 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	0.00% 0/457 • 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
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/454 • 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	0.22% 1/457 • Number of events 1 • 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
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.00% 0/454 • 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	0.44% 2/457 • Number of events 2 • 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
Psychiatric disorders Psychogenic seizure	0.22% 1/454 • Number of events 1 • 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	0.00% 0/457 • 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

Other adverse events

Measure	INV_MMR Group n=454 participants at risk Subjects received one dose of INV\_MMR (Priorix®) vaccine at Visit 1 (Day 0).	COM_MMR Group n=457 participants at risk Subjects received one dose of COM\_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
General disorders Injection site erythema	11.7% 53/454 • Number of events 53 • 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	11.4% 52/457 • Number of events 52 • 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
General disorders Injection site swelling	5.1% 23/454 • Number of events 23 • 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	6.3% 29/457 • Number of events 29 • 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
General disorders Pyrexia	2.9% 13/454 • Number of events 13 • 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	5.0% 23/457 • Number of events 23 • 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
General disorders Vaccination site pain	11.2% 51/454 • Number of events 51 • 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	11.2% 51/457 • Number of events 51 • 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

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
• Publication restrictions are in place

Restriction type: OTHER