Measles-Mumps-Rubella
Conditions
Keywords
Safety, Measles, mumps and rubella diseases, Immunogenicity
Brief summary
The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.
Detailed description
The GSK Biologicals' MMR vaccine (Priorix®) and Merck's MMR vaccine (M-M-R®II) are referred to as Inv\_MMR vaccine and Com\_MMR vaccine respectively. 2 lots of the comparator vaccine (Com\_MMR\_L1 and Com\_MMR\_L2) will be used, but the 2 lots will be analysed as a pool. The Inv\_MMR vaccine will be administered as a second dose to children who already received a first dose Com\_MMR vaccine. Since the second dose of a MMR vaccine in the US is routinely co-administered with DTaP-IPV vaccine (Kinrix®) and varicella vaccine (VV) (ProQuad® or Varivax®), some children will receive one dose of these vaccines along with either of the MMR vaccines.
Interventions
BIOLOGICALPriorix
One dose administered subcutaneously in the triceps region of the right arm.
BIOLOGICALM-M-R II
One dose administered subcutaneously in the triceps region of the right arm.
BIOLOGICALKinrix
One dose administered by deep intramuscular injection in the upper left deltoid.
BIOLOGICALProQuad
One dose administered subcutaneously in the triceps region of the left arm.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that they and/or their parent(s) or LAR/s can and will comply with the requirements of the protocol. * Male or female subjects 4 to 6 years of age at the time of vaccination. * Written informed consent is obtained from the parent(s)/LAR(s) of the subject (assent will be obtained from subjects in line with local rules and regulations). * Subjects in stable health as determined by investigator's physical examination and assessment of subjects' medical history. * Subjects received either a single dose of M-M-R II, M-M-R VaxPro or ProQuad in the second year of life. * For subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV and VV: * subjects received previous DTaP vaccine doses with INFANRIX® and/or PEDIARIX® for the first three doses and INFANRIX® for the fourth dose of the DTaP-containing vaccine. * subjects received a first dose of VV in the second year of life.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccine during the period starting 30 days before the day of study vaccination/s or planned during the entire study period. * Previous vaccination with a second dose of measles, mumps, rubella containing vaccine/s. * Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 180 days prior to Day 0 or any planned administration of immunosuppressive and immune-modifying drugs during the entire study. Inhaled and topical steroids are allowed. * Administration of immunoglobulins and/or any blood products during the period starting 180 days before entering the study or planned administration from the date of vaccination through the immunogenicity evaluation at Visit 2. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days prior to the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of live intranasal or inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. Inactivated influenza vaccine must be administered at a different location from the study vaccine. Any age appropriate vaccine may be given starting at Visit 2, and anytime thereafter. * Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * History of measles, mumps, and/or rubella disease. * Known exposure to measles, mumps and/or rubella during the period starting 30 days prior to enrollment. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin or gelatin. * Blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. * Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as temperature ≥38°C (100.4°F) measured by any age appropriate route. All vaccines can be administered to persons with a minor illness such as diarrhea, mild upper respiratory infection without fever. * Active untreated tuberculosis according to the subject's medical history. * Any other condition which, in the opinion of the investigator, prevents the subject from participating in the study. In addition, for subjects enrolled in the sub-cohort receiving co-administered DTaP-IPV+VV: * Previous vaccination with a second dose of varicella-containing vaccine. * Receipt of any varicella-containing vaccine during the period starting 90 days before the day of study vaccination. * History of varicella/zoster disease. * Known exposure to varicella/zoster during the period starting 30 days prior to enrollment. * History of diphtheria, tetanus, pertussis, and/or poliomyelitis disease. * Vaccination against diphtheria, tetanus, pertussis or polio given after the second year of life. * Occurrence of transient thrombocytopenia or neurological complications following an earlier immunization against diphtheria and/or tetanus toxoids. * Following a previous administration of DTP vaccine: temperature ≥40.6°C (\>105°F) during the period starting 48 hours not due to another identifiable cause, collapse or shock-like state during the period starting 48 hours, persistent, inconsolable crying lasting three hours or more within 48 hours, seizures with or without fever occurring during the period starting three days, or encephalopathy of unknown aetiology occurring during the period starting 7 days of a previous administration of DTP vaccine. * Hypersensitivity reaction to any component of the DTaP-IPV and/or varicella vaccines.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 42 days post vaccination (At Day 42) | Seroresponse was defined as post-vaccination anti-measles virus antibody concentration equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only. |
| Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | 42 days post vaccination (At Day 42) | Seroresponse was defined as post-vaccination anti-mumps virus antibody concentration ≥ 10 ELISA Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only. |
| Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | 42 days post vaccination (At Day 42) | Seroresponse was defined as post-vaccination anti-rubella virus antibody concentration ≥ 10 International Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only. |
| Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations | 42 days after vaccination (At Day 42) | Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only. |
| Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations | 42 days post vaccination (At Day 42) | Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only. |
| Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations | 42 days post vaccination (At Day 42) | Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations | 42 days post vaccination (At Day 42) | Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only. |
| Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | 42 days post vaccination (At Day 42) | Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | 42 days post vaccination (At Day 42) | Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL | 42 days post vaccination (At Day 42) | Analysis was done in sub-cohort 1 only. |
| Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | 42 days post vaccination (At Day 42) | Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \> 50mm. |
| Number of Subjects With Solicited General Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination. Analysis was done for sub-cohort 1 only. |
| Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value | 42 days post vaccination (At Day 42) | Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only. |
| Number of Subjects Reporting MMR Specific Solicited General Symptoms | During the 43-day (Days 0-42) post-vaccination period | Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. 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. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination. |
| Number of Subjects Reporting Investigator-confirmed Rash | During the 43-day (Days 0-42) post-vaccination period | Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination. |
| Number of Subjects With New Onset Chronic Diseases (NOCDs) | During the entire study period (from Day 0 up to Day 180) | NOCDs include autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | During the entire study period (from Day 0 up to Day 180) | The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported. |
| Number of Subjects With Unsolicited Adverse Events (AEs) | During the 43-day (Days 0-42) post-vaccination period | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | During the entire study period (from Day 0 up to Day 180) | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination. |
| Number of Subjects Reporting Fever | During the 43-day (Days 0-42) post-vaccination period | Any fever = fever ≥ 38°C; Grade 3 fever = fever \> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination. |
| Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations | 42 days post vaccination (At Day 42) | Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) | 42 days post vaccination (At Day 42) | Booster response was defined as: For subjects with pre-vaccination antibody concentration less than (\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42. For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT) | 42 days post vaccination (At Day 42) | Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA) | 42 days post vaccination (At Day 42) | Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only. |
| Number of Subjects With Antibody Booster Response to Pertactin (PRN) | 42 days post vaccination (At Day 42) | Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only. |
Countries
South Korea, Taiwan, United States
Participant flow
Recruitment details
Subjects were enrolled in 3 sub-cohorts. Sub-cohort 1: Inv\_MMR\_CO and Com\_MMR\_CO (Lot 1 or Lot 2), Sub-cohort 2: Inv\_MMR\_I and Com\_MMR\_I (Lot 1 or Lot 2) and Sub-cohort 3: Inv\_MMR\_S and Com\_MMR\_S (Lot 1 or Lot 2).
Pre-assignment details
4011 subjects were enrolled in the study with 4007 eligible subjects receiving a study vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Inv_MMR_CO Group Subjects received one dose of the study vaccine Priorix along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). | 802 |
| Com_MMR_CO Group Subjects received one dose of the licensed vaccine M-M-R II (also known as M-M-R Vax Pro) Lot 1 or Lot 2 along with Kinrix and ProQuad vaccines at Visit 1 (Day 0). | 298 |
| Inv_MMR_I Group Subjects received one dose of Priorix at Visit 1 (Day 0). | 796 |
| Com_MMR_I Group Subjects received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). | 303 |
| Inv_MMR_S Group Subjects in this safety cohort received one dose of Priorix at Visit 1 (Day 0). | 1,319 |
| Com_MMR_S Group Subjects in this safety cohort received one dose of M-M-R II (also known as M-M-R Vax Pro) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0). | 489 |
| Total | 4,007 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 36 | 16 | 24 | 7 | 31 | 11 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 2 | 0 | 1 | 0 |
| Overall Study | Others | 3 | 3 | 3 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 8 | 4 | 4 | 2 | 2 | 0 |
Baseline characteristics
| Characteristic | Inv_MMR_CO Group | Com_MMR_CO Group | Inv_MMR_I Group | Com_MMR_I Group | Inv_MMR_S Group | Com_MMR_S Group | Total |
|---|---|---|---|---|---|---|---|
| Age, Continuous | 4.1 Years STANDARD_DEVIATION 0.3 | 4.1 Years STANDARD_DEVIATION 0.3 | 4.4 Years STANDARD_DEVIATION 0.6 | 4.3 Years STANDARD_DEVIATION 0.6 | 4.4 Years STANDARD_DEVIATION 0.6 | 4.4 Years STANDARD_DEVIATION 0.6 | 4.3 Years STANDARD_DEVIATION 0.6 |
| Race/Ethnicity, Customized Race/Ethnicity African Heritage / African American | 96 Participants | 39 Participants | 48 Participants | 19 Participants | 94 Participants | 32 Participants | 328 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan Native | 130 Participants | 38 Participants | 15 Participants | 3 Participants | 4 Participants | 0 Participants | 190 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian - Central/South Asian Heritage | 12 Participants | 5 Participants | 7 Participants | 1 Participants | 8 Participants | 0 Participants | 33 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian - East Asian Heritage | 28 Participants | 6 Participants | 384 Participants | 146 Participants | 565 Participants | 209 Participants | 1338 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian - Japanese Heritage | 3 Participants | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants | 5 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian - South East Asian Heritage | 49 Participants | 25 Participants | 11 Participants | 4 Participants | 16 Participants | 8 Participants | 113 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Other Pacific Islander | 4 Participants | 2 Participants | 2 Participants | 0 Participants | 3 Participants | 0 Participants | 11 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 112 Participants | 45 Participants | 35 Participants | 9 Participants | 52 Participants | 22 Participants | 275 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White - Arabic / North African Heritage | 5 Participants | 3 Participants | 3 Participants | 3 Participants | 1 Participants | 0 Participants | 15 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White - Caucasian / European Heritage | 363 Participants | 135 Participants | 291 Participants | 117 Participants | 575 Participants | 218 Participants | 1699 Participants |
| Sex: Female, Male Female | 398 Participants | 134 Participants | 361 Participants | 153 Participants | 632 Participants | 225 Participants | 1903 Participants |
| Sex: Female, Male Male | 404 Participants | 164 Participants | 435 Participants | 150 Participants | 687 Participants | 264 Participants | 2104 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 802 | 0 / 298 | 0 / 796 | 0 / 303 | 0 / 1,319 | 0 / 489 |
| other Total, other adverse events | 544 / 802 | 198 / 298 | 410 / 796 | 156 / 303 | 702 / 1,319 | 279 / 489 |
| serious Total, serious adverse events | 4 / 802 | 0 / 298 | 14 / 796 | 1 / 303 | 25 / 1,319 | 9 / 489 |
Outcome results
Primary
Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days after vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations | 4335.0 mIU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations | 4215.6 mIU/mL |
| Inv_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations | 3646.6 mIU/mL |
| Com_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-measles Virus Antibody Concentrations | 3503.9 mIU/mL |
97.5% CI: [0.92, 1.06]ANCOVA
97.5% CI: [0.96, 1.1]ANCOVA
Primary
Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations | 170.5 EU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations | 190.1 EU/mL |
| Inv_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations | 167.2 EU/mL |
| Com_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-mumps Virus Antibody Concentrations | 176.2 EU/mL |
97.5% CI: [0.83, 1]ANCOVA
97.5% CI: [0.87, 1.06]ANCOVA
Primary
Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations | 96.4 IU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations | 96.0 IU/mL |
| Inv_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations | 98.9 IU/mL |
| Com_MMR_I Group | Evaluation of Immunogenicity in Terms of Anti-rubella Virus Antibody Concentrations | 98.7 IU/mL |
Comparison: Adjusted geometric mean concentration (GMC) ratio (Inv\_MMR\_CO group divided by Com\_MMR\_CO group) for antibodies to rubella virus.97.5% CI: [0.97, 1.09]ANCOVA
97.5% CI: [0.95, 1.07]ANCOVA
Primary
Number 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 equal to or above (≥) 200 milli-international Units per milliliter (mIU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on According to Protocol (ATP) cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for measles vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 697 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 249 Participants |
| Inv_MMR_I Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 736 Participants |
| Com_MMR_I Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 281 Participants |
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.97.5% CI: [-0.72, 1.98]
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.97.5% CI: [0.02, 2.97]
Primary
Number 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 Units per milliliter (EU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for mumps vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | 698 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | 250 Participants |
| Inv_MMR_I Group | Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | 736 Participants |
| Com_MMR_I Group | Number of Subjects With Anti-mumps Virus Antibody Concentration Equal to or Above the Cut-off-value | 283 Participants |
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.97.5% CI: [-0.72, 1.97]
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.97.5% CI: [-0.68, 1.75]
Primary
Number 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 Units per milliliter (IU/mL). Analysis was done in sub-cohorts 1 and 2 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for rubella vaccine component, did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | 696 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | 249 Participants |
| Inv_MMR_I Group | Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | 736 Participants |
| Com_MMR_I Group | Number of Subjects With Anti-rubella Virus Antibody Concentration Equal to or Above the Cut-off-value | 283 Participants |
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 1 should be at least 94.04% (=100%- the sum of type II errors associated to cohort 1.97.5% CI: [-0.98, 1.84]
Comparison: Power obtained using PASS 2005 (Likelihood Score \[Miettienen and Nurminen approach\]), one-sided non-inferiority test for the difference of two independent proportions, under the alternative associated to the reference value \& alpha=1.25%.~The global power to reach all non-inferiority objectives of Priorix vs. M-M-R II in sub-cohort 2 should be at least 98.88% (=100%- the sum of type II error associated to cohort 2.97.5% CI: [-0.68, 1.75]
Secondary
Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were expressed as GMCs in IU/mL. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations | Anti-D | 17.2 IU/mL |
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations | Anti-T | 7.4 IU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations | Anti-D | 17.8 IU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-D and Anti-T Antibody Concentrations | Anti-T | 8.4 IU/mL |
Secondary
Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers
Antibody titers were expressed as Geometric Mean Titers (GMTs) in ED50. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 1618.7 ED50 |
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 2026.4 ED50 |
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 2753.5 ED50 |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 1 | 1587.3 ED50 |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 2 | 2206.1 ED50 |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-polio Virus Types 1, 2 and 3 Antibody Titers | Anti-Polio 3 | 3040.6 ED50 |
Secondary
Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were expressed as GMCs in EU/mL. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 76.6 EU/mL |
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 316.2 EU/mL |
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 402.2 EU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PT | 73.9 EU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-FHA | 319.3 EU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations | Anti-PRN | 427.3 EU/mL |
Secondary
Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations
Antibody concentrations were expressed as GMCs in mIU/mL. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Inv_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations | 887.7 mIU/mL |
| Com_MMR_CO Group | Evaluation of Immunogenicity in Terms of Anti-VZV Antibody Concentrations | 820.4 mIU/mL |
Secondary
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits
The number of subjects reporting adverse events resulting in Emergency Room (ER) visits is reported.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 61 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 29 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 64 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 22 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 102 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER) Visits | 36 Participants |
Secondary
Number of Subjects Reporting Fever
Any fever = fever ≥ 38°C; Grade 3 fever = fever \> 39.5°C; Related = fever assessed by the investigator as causally related to study vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects Reporting Fever | Grade 3 fever | 7 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Fever | Related fever | 100 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Fever | Any fever | 177 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Fever | Grade 3 fever | 6 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Fever | Any fever | 67 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Fever | Related fever | 32 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Fever | Grade 3 fever | 14 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Fever | Any fever | 146 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Fever | Related fever | 27 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Fever | Related fever | 11 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Fever | Any fever | 58 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Fever | Grade 3 fever | 9 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Fever | Grade 3 fever | 21 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Fever | Any fever | 257 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Fever | Related fever | 52 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Fever | Grade 3 fever | 8 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Fever | Any fever | 96 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Fever | Related fever | 25 Participants |
Secondary
Number of Subjects Reporting Investigator-confirmed Rash
Assessed any rash, varicella-like rash, measles/rubella-like rash, Grade 3, related. Any= occurrence of rash regardless of intensity grade. Grade 3 measles/rubella/varicella-like rash = Rash with more than 150 lesions. Other Grade 3 Rash = Rash that prevented normal, everyday activities. Related= Rash assessed by the investigator as causally related to study vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 14 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 2 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 1 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 12 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 50 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 7 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 3 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 4 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 25 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 61 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 3 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 2 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 8 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 11 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 12 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 2 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 41 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 9 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 18 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 2 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 10 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 4 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 1 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 1 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 3 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 28 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 1 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 5 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 11 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 24 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 2 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 22 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 6 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 7 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 1 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 2 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 4 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 27 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 3 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 1 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 26 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 1 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 4 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 1 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 5 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 10 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 1 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 2 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 2 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 3 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 37 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 12 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 9 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 2 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 1 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 3 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 9 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 1 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 2 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 2 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 2 Participants |
| Com_MMR_I Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 3 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 56 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 6 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 4 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 8 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 42 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 8 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 36 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 4 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 4 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 7 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 15 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 2 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 3 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any with fever | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Varicella like | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Varicella like | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized with fever | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized other site | 19 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized administration site | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any localized or generalized | 23 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Measles/Rubella like | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized any | 19 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any related | 3 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any grade 3 | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized related | 2 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Related | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized Grade 3 | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Measles/Rubella like | 2 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Any Varicella like | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized with fever | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Generalized any | 4 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Grade 3 | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting Investigator-confirmed Rash | Localized Measles/Rubella like | 1 Participants |
Secondary
Number of Subjects Reporting MMR Specific Solicited General Symptoms
Assessed MMR specific symptoms were parotid gland swelling and any suspected signs of meningism including febrile convulsions. 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. Grade 3 Sign of meningism (any suspected signs including febrile convulsions) = An event which prevented normal, everyday activities. Related = symptom assessed by the investigator as causally related to study vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 0 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 0 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 0 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Inv_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 0 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 2 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 2 Participants |
| Com_MMR_CO Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 0 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 1 Participants |
| Inv_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 1 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 1 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Com_MMR_I Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 0 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 1 Participants |
| Inv_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Parotid gland swelling | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Sign of meningism | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Parotid gland swelling | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Related Parotid gland swelling | 1 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Grade 3 Sign of meningism | 0 Participants |
| Com_MMR_S Group | Number of Subjects Reporting MMR Specific Solicited General Symptoms | Any Sign of meningism | 0 Participants |
Secondary
Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T)
Booster response was defined as: For subjects with pre-vaccination antibody concentration less than (\<) 0.1 IU/mL, antibody concentration ≥ 0.4 IU/ml at Day 42. For subjects with pre-vaccination antibody concentration ≥ 0.1 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) | Anti-D | 657 Participants |
| Inv_MMR_CO Group | Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) | Anti-T | 621 Participants |
| Com_MMR_CO Group | Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) | Anti-D | 233 Participants |
| Com_MMR_CO Group | Number of Subjects With Antibody Booster Response to Diphtheria Toxin (Anti-D) and Tetanus Toxin (Anti-T) | Anti-T | 224 Participants |
Secondary
Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA)
Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.184 IU/ml at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.184 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.184 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA) | 620 Participants |
| Com_MMR_CO Group | Number of Subjects With Antibody Booster Response to Filamentous Hemagglutinin (FHA) | 221 Participants |
Secondary
Number of Subjects With Antibody Booster Response to Pertactin (PRN)
Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 8.748 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 8.748 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 8.748 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Antibody Booster Response to Pertactin (PRN) | 657 Participants |
| Com_MMR_CO Group | Number of Subjects With Antibody Booster Response to Pertactin (PRN) | 233 Participants |
Secondary
Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT)
Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 10.772 IU/mL at Day 42. For initially seropositive subjects with pre-vaccination antibody concentration \< 10.772 IU/mL: antibody concentration at Day 42 ≥ 4 fold the pre-vaccination antibody concentration. For initially seropositive subjects with pre-vaccination antibody concentration ≥ 10.772 IU/mL: antibody concentration at Day 42 ≥ 2 fold the pre-vaccination antibody concentration. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT) | 643 Participants |
| Com_MMR_CO Group | Number of Subjects With Antibody Booster Response to Pertussis Toxin (PT) | 225 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL
Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D | 684 Participants |
| Inv_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T | 684 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-D | 243 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 0.1 IU/mL | Anti-T | 243 Participants |
Secondary
Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL
Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL | Anti-D | 683 Participants |
| Inv_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL | Anti-T | 678 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL | Anti-T | 243 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ 1.0 IU/mL | Anti-D | 242 Participants |
Secondary
Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value
Seroresponse was defined as post-vaccination anti-VZV antibody concentration ≥ 75 mIU/mL. Analysis was done in sub-cohort 1 only.
Time frame: 42 days post vaccination (At Day 42)
Population: This analysis was performed on ATP cohort for immunogenicity which included all evaluable subjects with post-vaccination serology results available for at least one of the three vaccine components (measles, mumps, or rubella), did not meet any elimination criteria up to Visit 2 blood sample \& complied with protocol procedures.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value | 693 Participants |
| Com_MMR_CO Group | Number of Subjects With Anti-varicella Zoster Virus (VZV) Antibody Concentration Equal to or Above the Cut-off-value | 247 Participants |
Secondary
Number of Subjects With New Onset Chronic Diseases (NOCDs)
NOCDs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 8 Participants |
| Com_MMR_CO Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 4 Participants |
| Inv_MMR_I Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 6 Participants |
| Com_MMR_I Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 0 Participants |
| Inv_MMR_S Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 11 Participants |
| Com_MMR_S Group | Number of Subjects With New Onset Chronic Diseases (NOCDs) | 3 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life-threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time frame: During the entire study period (from Day 0 up to Day 180)
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| Com_MMR_CO Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |
| Inv_MMR_I Group | Number of Subjects With Serious Adverse Events (SAEs) | 14 Participants |
| Com_MMR_I Group | Number of Subjects With Serious Adverse Events (SAEs) | 1 Participants |
| Inv_MMR_S Group | Number of Subjects With Serious Adverse Events (SAEs) | 25 Participants |
| Com_MMR_S Group | Number of Subjects With Serious Adverse Events (SAEs) | 9 Participants |
Secondary
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were drowsiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Drowsiness = Drowsiness that prevented normal activity, Grade 3 Loss of appetite = Not eating at all. Related = symptom assessed by the investigator as causally related to study vaccination. Analysis was done for sub-cohort 1 only.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 199 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 10 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 180 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 154 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 2 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 135 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Grade 3 Loss of appetite | 2 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Any Drowsiness | 72 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Any Loss of appetite | 59 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Grade 3 Drowsiness | 3 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Related Loss of appetite | 56 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited General Symptoms | Related Drowsiness | 63 Participants |
Secondary
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 Pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than 50 millimeters (m m ) i.e . \> 50mm.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented. Analysis of the solicited symptoms based on the Total Vaccinated cohort included only subjects/doses with documented safety data (i.e., symptom screen/sheet completed).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 295 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 157 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 82 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 22 Participants |
| Inv_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 9 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 109 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 4 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 69 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 4 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 28 Participants |
| Com_MMR_CO Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 3 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 146 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 6 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 152 Participants |
| Inv_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 64 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 64 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 23 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Com_MMR_I Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 53 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 278 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 5 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 108 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 242 Participants |
| Inv_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Redness | 90 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Pain | 123 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Pain | 2 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Swelling | 0 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Grade 3 Redness | 0 Participants |
| Com_MMR_S Group | Number of Subjects With Solicited Local Symptoms | Any Swelling | 42 Participants |
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: This analysis was performed on Total Vaccinated cohort which included all vaccinated subjects with at least one vaccine administration documented.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Inv_MMR_CO Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 276 Participants |
| Com_MMR_CO Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 90 Participants |
| Inv_MMR_I Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 314 Participants |
| Com_MMR_I Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 112 Participants |
| Inv_MMR_S Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 508 Participants |
| Com_MMR_S Group | Number of Subjects With Unsolicited Adverse Events (AEs) | 186 Participants |