Rubella, Mumps, Measles, Measles-Mumps-Rubella Vaccine
Conditions
Keywords
Measles, Mumps, Rubella, Varicella Vaccine, Children, Immunogenicity, Safety, Humans, Combined Vaccine, Vaccines
Brief summary
The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine. The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.
Interventions
BIOLOGICALGSK Biological's investigational vaccine 209762
Subcutaneous injection, one dose
BIOLOGICALM-M-R® II (Merck and Co)
Subcutaneous injection, one dose
BIOLOGICALVarivax®
Subcutaneous injection, one dose
BIOLOGICALHavrix®
Intramuscular injection, one dose
BIOLOGICALPrevnar®
Intramuscular injection, one dose
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of vaccination. * Written informed consent obtained from the parent/guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Have previously received three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.
Exclusion criteria
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period. * 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 (pharmaceutical product or device). * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine and Hib vaccine. * Previous vaccination against measles, mumps, rubella and/or varicella. * Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine. * History of measles, mumps, rubella, varicella/zoster and hepatitis A diseases. * Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus (HIV) infection. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * Hypersensitivity to latex * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures, including febrile seizures. * Acute disease at the time of enrolment. * Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | At Day 42 after administration of a dose of Priorix vaccine. | Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). |
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | At Day 42 after administration of a dose of Priorix vaccine. | Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination. |
| Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | At Day 42 after administration of a dose of Priorix vaccine. | Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<24 ED50 prior to vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-mumps Virus Antibody Concentrations | At Day 42 after administration of a dose of Priorix vaccine. | Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer \< 24 ED50 prior to vaccination. |
| Anti-rubella Virus Antibody Concentrations | At Day 42 after administration of a dose of Priorix vaccine. | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination. |
| Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | At Day 42 after vaccination | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL. |
| Anti-varicella Antibody Concentrations. | At Day 42 after administration of a dose of Varivax vaccine. | Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration \< 25 mIU/mL prior to vaccination. |
| Anti-hepatitis A Virus Antibody Concentrations. | At Day 42 after administration of a dose of Havrix vaccine. | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations \<15 mIU/mL prior to vaccination. |
| Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | At Day 42 after administration of a dose of Havrix vaccine. | Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL). |
| Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | At 1 year post-vaccination | Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). |
| Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | During the 43-day (Days 0-42) post-vaccination period | — |
| Number of Subjects Reporting Febrile Convulsions | During the 43-day (Days 0-42) post-vaccination period | Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism. |
| Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | At 1 year post-vaccination | Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer \< 24 ED50 prior to vaccination. |
| Number of Subjects Reporting Other Rash. | During the 43-day (Days 0-42) post-vaccination period | Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature |
| Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | At 1 year post-vaccination | Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50. |
| Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | At 1 year post-vaccination | Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination. |
| Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | During the 43-day (Days 0-42) post-vaccination period | Swelling with accompanying general symptoms |
| Number of Subjects With Solicited Local Symptoms. | During the 4-day (Days 0-3) post-vaccination period | Solicited local symptoms assessed were pain, redness and swelling. |
| Number of Subjects Reporting Medically Attended Visit (MAEs) | During the 43-day (Days 0-42) post-vaccination period | MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. |
| 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 = the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Number of Subjects With Solicited General Symptoms. | During the 15-day (Days 0-14) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. |
| Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | From Day 0 to Day 180 after vaccination | NOCIs included autoimmune disorders, asthma, type I diabetes, allergies. |
| Number of Subjects Reporting Serious Adverse Events (SAEs) | From Day 0 to Day 180 after vaccination | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Serious Adverse Events (SAEs). | From Day 180 to Day 730 after vaccination | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | From Day 0 to Day 180 after vaccination | — |
| Anti-mumps Virus Antibody Titers (Unenhanced PRN) | At 1 year post-vaccination | Antibody titers were expressed as Geometric Mean Titer (GMT). |
| Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | At 1 year post-vaccination | Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50). |
| Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | At 1 year post-vaccination | Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<5 EU/mL prior to vaccination. |
| Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | At 1 year post-vaccination | Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL) |
| Anti-mumps Virus Antibody Concentrations (PPD ELISA) | At 2 years post-vaccination | Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<5 EU/mL prior to vaccination. |
| Number of Subjects Reporting Fever. | During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period | fever is assessed for temperature ≥38°C/100.4°F and \>39.5°C/103.1°F as measured rectally. |
| Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | At Day 42 after administration of a dose of Varivax vaccine. | Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL). |
| Anti-measles Virus Antibody Concentrations | At Day 42 after administration of a dose of Priorix vaccine. | Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination. |
Countries
Puerto Rico, United States
Participant flow
Recruitment details
The study was divided in 3 phases: the active phase (up to Day 42), the extended safety follow-up (ESFU) phase (up to Day 180) and the antibody persistence phase (up to Day 730).
Pre-assignment details
The number of subjects enrolled was 1259. 39 subjects were enrolled in the study but did not receive a subject number and were never vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| Priorix 1 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. | 304 |
| Priorix 2 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. | 304 |
| Priorix 3 Group Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. | 304 |
| MMR-II Group Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines. | 308 |
| Total | 1,220 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 1 |
| Overall Study | Blood draws | 0 | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 7 | 19 | 17 | 12 |
| Overall Study | Migration from study area | 0 | 3 | 1 | 0 |
| Overall Study | Protocol Violation | 0 | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 6 | 6 | 19 |
Baseline characteristics
| Characteristic | Priorix 1 Group | Priorix 2 Group | Priorix 3 Group | MMR-II Group | Total |
|---|---|---|---|---|---|
| Age, Continuous | 12.4 Months STANDARD_DEVIATION 0.75 | 12.4 Months STANDARD_DEVIATION 0.73 | 12.2 Months STANDARD_DEVIATION 0.56 | 12.4 Months STANDARD_DEVIATION 0.75 | 12.4 Months STANDARD_DEVIATION 0.7 |
| Sex: Female, Male Female | 156 Participants | 144 Participants | 157 Participants | 139 Participants | 596 Participants |
| Sex: Female, Male Male | 148 Participants | 160 Participants | 147 Participants | 169 Participants | 624 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 304 | 0 / 304 | 0 / 304 | 0 / 308 |
| other Total, other adverse events | 240 / 304 | 216 / 304 | 219 / 304 | 221 / 308 |
| serious Total, serious adverse events | 1 / 304 | 7 / 304 | 8 / 304 | 10 / 308 |
Outcome results
Primary
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value.
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | 245 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | 236 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | 236 Subjects |
| MMR-II Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value. | 248 Subjects |
Primary
Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value.
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 Estimated Dose 50 (ED50). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<24 ED50 prior to vaccination.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | 175 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | 183 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | 175 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Titer Equal to or Above the Cut-off-value. | 175 Subjects |
Primary
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 244 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 235 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 233 Subjects |
| MMR-II Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 249 Subjects |
Secondary
Anti-hepatitis A Virus Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-hepatitis A virus antibody concentrations \<15 mIU/mL prior to vaccination.
Time frame: At Day 42 after administration of a dose of Havrix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-hepatitis A Virus Antibody Concentrations. | 33.8 mIU/mL |
| Priorix 2 Group | Anti-hepatitis A Virus Antibody Concentrations. | 39.2 mIU/mL |
| Priorix 3 Group | Anti-hepatitis A Virus Antibody Concentrations. | 39.4 mIU/mL |
| MMR-II Group | Anti-hepatitis A Virus Antibody Concentrations. | 42.1 mIU/mL |
Secondary
Anti-measles Virus Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-measles Virus Antibody Concentrations | 3224.3 mIU/mL |
| Priorix 2 Group | Anti-measles Virus Antibody Concentrations | 3708.2 mIU/mL |
| Priorix 3 Group | Anti-measles Virus Antibody Concentrations | 3534.7 mIU/mL |
| MMR-II Group | Anti-measles Virus Antibody Concentrations | 3828.1 mIU/mL |
Secondary
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-measles Virus Antibody Concentrations | 3361.1 mIU/mL |
| Priorix 2 Group | Anti-measles Virus Antibody Concentrations | 3963.8 mIU/mL |
| Priorix 3 Group | Anti-measles Virus Antibody Concentrations | 3360.3 mIU/mL |
| MMR-II Group | Anti-measles Virus Antibody Concentrations | 4022.1 mIU/mL |
Secondary
Anti-measles Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in mIU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-measles virus antibody concentrations \<150 mIU/mL prior to vaccination.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-measles Virus Antibody Concentrations | 2798.7 mIU/mL |
| Priorix 2 Group | Anti-measles Virus Antibody Concentrations | 2878.2 mIU/mL |
| Priorix 3 Group | Anti-measles Virus Antibody Concentrations | 2593.1 mIU/mL |
| MMR-II Group | Anti-measles Virus Antibody Concentrations | 2949.5 mIU/mL |
Secondary
Anti-mumps Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer \< 24 ED50 prior to vaccination.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Concentrations | 242.0 Titers |
| Priorix 2 Group | Anti-mumps Virus Antibody Concentrations | 265.0 Titers |
| Priorix 3 Group | Anti-mumps Virus Antibody Concentrations | 253.4 Titers |
| MMR-II Group | Anti-mumps Virus Antibody Concentrations | 267.6 Titers |
Secondary
Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<5 EU/mL prior to vaccination.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | 47.3 EU/mL |
| Priorix 2 Group | Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | 42.9 EU/mL |
| Priorix 3 Group | Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | 42.5 EU/mL |
| MMR-II Group | Anti-mumps Virus Antibody Concentrations (Pharmaceutical Product Development (PPD) ELISA) | 58.6 EU/mL |
Secondary
Anti-mumps Virus Antibody Concentrations (PPD ELISA)
Antibody concentrations are expressed as Geometric Mean Concentrations (GMC) in ELISA units per milliliter (EU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<5 EU/mL prior to vaccination.
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Concentrations (PPD ELISA) | 47.8 EU/mL |
| Priorix 2 Group | Anti-mumps Virus Antibody Concentrations (PPD ELISA) | 50.2 EU/mL |
| Priorix 3 Group | Anti-mumps Virus Antibody Concentrations (PPD ELISA) | 54.0 EU/mL |
| MMR-II Group | Anti-mumps Virus Antibody Concentrations (PPD ELISA) | 59.2 EU/mL |
Secondary
Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN))
Antibody titers were expressed as Geometric Mean Titer (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody titer \< 24 ED50 prior to vaccination.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | 162.8 Titers |
| Priorix 2 Group | Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | 188.3 Titers |
| Priorix 3 Group | Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | 176.2 Titers |
| MMR-II Group | Anti-mumps Virus Antibody Titers (Enhanced Plaque Reduction Neutralization (PRN)) | 185.5 Titers |
Secondary
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody titers were expressed as Geometric Mean Titer (GMT).
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 31.0 Titer |
| Priorix 2 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 46.1 Titer |
| Priorix 3 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 39.3 Titer |
| MMR-II Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 46.6 Titer |
Secondary
Anti-mumps Virus Antibody Titers (Unenhanced PRN)
Antibody concentrations are expressed as Geometric Mean Titer (GMT).
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 43.4 Titer |
| Priorix 2 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 48.9 Titer |
| Priorix 3 Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 57.4 Titer |
| MMR-II Group | Anti-mumps Virus Antibody Titers (Unenhanced PRN) | 60.7 Titer |
Secondary
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-rubella Virus Antibody Concentrations | 138.1 IU/mL |
| Priorix 2 Group | Anti-rubella Virus Antibody Concentrations | 145.4 IU/mL |
| Priorix 3 Group | Anti-rubella Virus Antibody Concentrations | 136.5 IU/mL |
| MMR-II Group | Anti-rubella Virus Antibody Concentrations | 166.8 IU/mL |
Secondary
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination.
Time frame: At Day 42 after administration of a dose of Priorix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-rubella Virus Antibody Concentrations | 72.2 IU/mL |
| Priorix 2 Group | Anti-rubella Virus Antibody Concentrations | 77.7 IU/mL |
| Priorix 3 Group | Anti-rubella Virus Antibody Concentrations | 68.2 IU/mL |
| MMR-II Group | Anti-rubella Virus Antibody Concentrations | 89.4 IU/mL |
Secondary
Anti-rubella Virus Antibody Concentrations
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in IU/mL. The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination.
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-rubella Virus Antibody Concentrations | 78.0 IU/mL |
| Priorix 2 Group | Anti-rubella Virus Antibody Concentrations | 79.5 IU/mL |
| Priorix 3 Group | Anti-rubella Virus Antibody Concentrations | 81.7 IU/mL |
| MMR-II Group | Anti-rubella Virus Antibody Concentrations | 93.1 IU/mL |
Secondary
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time frame: At Day 0 before vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 0.54 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19F | 0.40 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18C | 0.88 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-6B | 0.53 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 0.64 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-9V | 1.01 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 3.01 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19F | 0.40 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 2.82 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-9V | 1.13 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18C | 0.97 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 0.63 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-6B | 0.57 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 0.61 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 2.54 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 0.67 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-6B | 0.52 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-9V | 1.04 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18C | 0.97 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19F | 0.44 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 0.65 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-9V | 1.26 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 0.85 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19F | 0.45 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-6B | 0.67 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 0.67 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18C | 1.00 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 2.76 µg/mL |
Secondary
Anti-S. Pneumoniae Antibody Concentrations (by Serotype).
Antibody concentrations are expressed as Geometric Mean Concentrations (GMCs) in µg/mL.
Time frame: At Day 42 after vaccination
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 3.57 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19 F | 2.42 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18 C | 6.20 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S. PNEU-6B | 5.68 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 9.34 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU 9V | 6.56 µg/mL |
| Priorix 1 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 9.23 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19 F | 2.46 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 8.33 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU 9V | 7.30 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18 C | 6.62 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 9.27 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S. PNEU-6B | 5.87 µg/mL |
| Priorix 2 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 3.72 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 7.58 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 3.40 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S. PNEU-6B | 5.41 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU 9V | 5.81 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18 C | 6.15 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19 F | 2.34 µg/mL |
| Priorix 3 Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 8.33 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU 9V | 7.80 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-23 F | 11.49 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-19 F | 2.59 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S. PNEU-6B | 7.22 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-4 | 3.80 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-18 C | 6.73 µg/mL |
| MMR-II Group | Anti-S. Pneumoniae Antibody Concentrations (by Serotype). | Anti-S.PNEU-14 | 7.97 µg/mL |
Secondary
Anti-varicella Antibody Concentrations.
Antibody concentrations are expressed as Geometric Mean Titers (GMT). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with antibody concentration \< 25 mIU/mL prior to vaccination.
Time frame: At Day 42 after administration of a dose of Varivax vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Priorix 1 Group | Anti-varicella Antibody Concentrations. | 245.5 mIU/mL |
| Priorix 2 Group | Anti-varicella Antibody Concentrations. | 235.2 mIU/mL |
| Priorix 3 Group | Anti-varicella Antibody Concentrations. | 236.0 mIU/mL |
| MMR-II Group | Anti-varicella Antibody Concentrations. | 255.9 mIU/mL |
Secondary
Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits.
Time frame: From Day 0 to Day 180 after vaccination
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | 27 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | 28 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | 22 Subjects |
| MMR-II Group | Number of Subjects Reporting Conditions Prompting Emergency Room (ER) Visits. | 26 Subjects |
Secondary
Number of Subjects Reporting Febrile Convulsions
Timing of febrile convulsions: events occured on Day 29 in the Priorix 2 Group and Day 0 in the MMR II Group. All cases of febrile convulsions were case of meningism.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Febrile Convulsions | 0 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Febrile Convulsions | 1 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Febrile Convulsions | 0 Subjects |
| MMR-II Group | Number of Subjects Reporting Febrile Convulsions | 1 Subjects |
Secondary
Number of Subjects Reporting Fever.
fever is assessed for temperature ≥38°C/100.4°F and \>39.5°C/103.1°F as measured rectally.
Time frame: During the 15-day (Days 0-14) and 43 days (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) >39.5°C | 10 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) >39.5°C | 20 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) ≥38.0°C | 65 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) ≥38.0°C | 103 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) ≥38.0°C | 79 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) >39.5°C | 14 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) >39.5°C | 7 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) ≥38.0°C | 104 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) ≥38.0°C | 64 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) >39.5°C | 18 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) ≥38.0°C | 104 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) >39.5°C | 9 Subjects |
| MMR-II Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) >39.5°C | 13 Subjects |
| MMR-II Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) >39.5°C | 8 Subjects |
| MMR-II Group | Number of Subjects Reporting Fever. | Day 43 (N= 283; 275; 283; 277) ≥38.0°C | 85 Subjects |
| MMR-II Group | Number of Subjects Reporting Fever. | Day 15 (N= 283; 275; 283; 277) ≥38.0°C | 56 Subjects |
Secondary
Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Varicella like | 0 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Measles/Rubella like | 6 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Measles/Rubella like | 7 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Varicella like | 4 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Varicella like | 0 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Measles/Rubella like | 5 Subjects |
| MMR-II Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Varicella like | 0 Subjects |
| MMR-II Group | Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash and Varicella-like Rash. | Measles/Rubella like | 5 Subjects |
Secondary
Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling.
Swelling with accompanying general symptoms
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | 3 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | 3 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | 5 Subjects |
| MMR-II Group | Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling. | 2 Subjects |
Secondary
Number of Subjects Reporting Medically Attended Visit (MAEs)
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Medically Attended Visit (MAEs) | 99 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Medically Attended Visit (MAEs) | 99 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Medically Attended Visit (MAEs) | 97 Subjects |
| MMR-II Group | Number of Subjects Reporting Medically Attended Visit (MAEs) | 107 Subjects |
Secondary
Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs).
NOCIs included autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Day 0 to Day 180 after vaccination
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | 5 Subjects |
| Priorix 2 Group | Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | 2 Subjects |
| Priorix 3 Group | Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | 4 Subjects |
| MMR-II Group | Number of Subjects Reporting New Onset Chronic Illnesses (NOCIs). | 2 Subjects |
Secondary
Number of Subjects Reporting Other Rash.
Other rash = not confirmed by the investigator to be either measles/rubella-like or varicella-like in nature
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Other Rash. | Localized or generalized | 72 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Other Rash. | With fever | 26 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Other Rash. | Grade 3 | 11 Subjects |
| Priorix 1 Group | Number of Subjects Reporting Other Rash. | Related | 9 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Other Rash. | With fever | 29 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Other Rash. | Grade 3 | 10 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Other Rash. | Related | 14 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Other Rash. | Localized or generalized | 74 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Other Rash. | Grade 3 | 6 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Other Rash. | With fever | 23 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Other Rash. | Related | 6 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Other Rash. | Localized or generalized | 60 Subjects |
| MMR-II Group | Number of Subjects Reporting Other Rash. | Related | 6 Subjects |
| MMR-II Group | Number of Subjects Reporting Other Rash. | With fever | 23 Subjects |
| MMR-II Group | Number of Subjects Reporting Other Rash. | Localized or generalized | 60 Subjects |
| MMR-II Group | Number of Subjects Reporting Other Rash. | Grade 3 | 6 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 0 to Day 180 after vaccination
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 1 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 6 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 7 Subjects |
| MMR-II Group | Number of Subjects Reporting Serious Adverse Events (SAEs) | 9 Subjects |
Secondary
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From Day 180 to Day 730 after vaccination
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Subjects |
| Priorix 2 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Subjects |
| Priorix 3 Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 0 Subjects |
| MMR-II Group | Number of Subjects Reporting Serious Adverse Events (SAEs). | 1 Subjects |
Secondary
Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-hepatitis A antibody cut-off-value assessed was ≥15 milli-International Units per milliliter (mIU/mL).
Time frame: At Day 42 after administration of a dose of Havrix vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | 98 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | 99 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | 94 Subjects |
| MMR-II Group | Number of Subjects With Anti-hepatitis A Antibody Concentrations Equal to or Above the Cut-off-value. | 110 Subjects |
Secondary
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 171 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 159 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 168 Subjects |
| MMR-II Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 166 Subjects |
Secondary
Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value
Anti-measles virus antibody cut-off-value assessed was ≥ 200 milli-International Units per milliliter (mIU/mL).
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 211 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 211 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 218 Subjects |
| MMR-II Group | Number of Subjects With Anti-measles Virus Antibody Concentration Equal to or Above the Cut-off-value | 209 Subjects |
Secondary
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 128 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 125 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 136 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 134 Subjects |
Secondary
Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA)
Anti-mumps virus antibody cut-off-value assessed was ≥ 10 ELISA units per milliliter (EU/mL)
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 155 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 159 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 162 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Concentrations Above the Cut-off Value (PPD ELISA) | 164 Subjects |
Secondary
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 51 ED50.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | 169 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | 170 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | 171 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Enhanced PRN) | 170 Subjects |
Secondary
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 173 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 186 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 184 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 173 Subjects |
Secondary
Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN)
Anti-mumps virus antibody cut-off-value assessed was ≥ 4 Estimated Dose 50 (ED50).
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 144 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 134 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 152 Subjects |
| MMR-II Group | Number of Subjects With Anti-mumps Virus Antibody Titers Above the Cut-off Value (Unenhanced PRN) | 144 Subjects |
Secondary
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL).
Time frame: At 2 years post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 2, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 2 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 171 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 158 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 168 Subjects |
| MMR-II Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 166 Subjects |
Secondary
Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value.
Anti-rubella virus antibody cut-off-value assessed was ≥ 10 International Units per milliliter (IU/mL). The analysis was performed on seronegative subjects. Seronegative subjects are subjects with anti-rubella virus antibody concentrations \<4 IU/mL prior to vaccination.
Time frame: At 1 year post-vaccination
Population: The analysis was based on the according-to-protocol (ATP) cohort for persistence at Year 1, which included all eligible subjects who received study vaccine/comparator, for whom data concerning immunogenicity outcome measures were available At Day 0, Day 42 post-vaccination, and Year 1 post-vaccination and who complied with blood sampling schedules.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 212 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 213 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 217 Subjects |
| MMR-II Group | Number of Subjects With Anti-rubella Virus Antibody Concentrations Equal to or Above the Cut-off-value. | 210 Subjects |
Secondary
Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value.
Anti-varicella virus antibody cut-off-value assessed was ≥ 75 milli-International Units per milliliter (mIU/mL).
Time frame: At Day 42 after administration of a dose of Varivax vaccine.
Population: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included eligible subjects with pre- and post-vaccination serology results available.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | 240 Subjects |
| Priorix 2 Group | Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | 230 Subjects |
| Priorix 3 Group | Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | 230 Subjects |
| MMR-II Group | Number of Subjects With Anti-varicella Antibody Concentration Equal to or Above the Cut-off-value. | 241 Subjects |
Secondary
Number of Subjects With Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Time frame: During the 15-day (Days 0-14) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Priorix 1 Group | Number of Subjects With Solicited General Symptoms. | Any drowsiness | 133 Subjects |
| Priorix 1 Group | Number of Subjects With Solicited General Symptoms. | Any loss of appetite | 111 Subjects |
| Priorix 1 Group | Number of Subjects With Solicited General Symptoms. | Any irritability | 180 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited General Symptoms. | Any drowsiness | 106 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited General Symptoms. | Any loss of appetite | 77 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited General Symptoms. | Any irritability | 141 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited General Symptoms. | Any irritability | 150 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited General Symptoms. | Any drowsiness | 113 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited General Symptoms. | Any loss of appetite | 110 Subjects |
| MMR-II Group | Number of Subjects With Solicited General Symptoms. | Any drowsiness | 109 Subjects |
| MMR-II Group | Number of Subjects With Solicited General Symptoms. | Any loss of appetite | 94 Subjects |
| MMR-II Group | Number of Subjects With Solicited General Symptoms. | Any irritability | 153 Subjects |
Secondary
Number of Subjects With Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented and symptom sheet completed, only on subjects that reported the specific symptom.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Priorix 1 Group | Number of Subjects With Solicited Local Symptoms. | Pain | 70 Subjects |
| Priorix 1 Group | Number of Subjects With Solicited Local Symptoms. | Swelling | 20 Subjects |
| Priorix 1 Group | Number of Subjects With Solicited Local Symptoms. | Redness | 45 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited Local Symptoms. | Pain | 70 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited Local Symptoms. | Swelling | 26 Subjects |
| Priorix 2 Group | Number of Subjects With Solicited Local Symptoms. | Redness | 47 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited Local Symptoms. | Redness | 41 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited Local Symptoms. | Pain | 79 Subjects |
| Priorix 3 Group | Number of Subjects With Solicited Local Symptoms. | Swelling | 19 Subjects |
| MMR-II Group | Number of Subjects With Solicited Local Symptoms. | Pain | 67 Subjects |
| MMR-II Group | Number of Subjects With Solicited Local Symptoms. | Swelling | 15 Subjects |
| MMR-II Group | Number of Subjects With Solicited Local Symptoms. | Redness | 47 Subjects |
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 = 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: The analysis of safety was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Priorix 1 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 170 Subjects |
| Priorix 2 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 153 Subjects |
| Priorix 3 Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 164 Subjects |
| MMR-II Group | Number of Subjects With Unsolicited Adverse Events (AEs). | 169 Subjects |