Varicella, Rubella, Mumps, Measles
Conditions
Keywords
Mumps, Immunogenicity, Vaccines, Safety, Rubella, Combined Vaccine, Varicella Vaccine, Children, Measles, Humans
Brief summary
The purpose of this study is to assess non-inferiority of two different vaccination regimens using GSK Biological's MMRV vaccine (two doses at 9 and 15 months) or Priorix™ (9 months) and one dose of MMRV vaccine (15 months) to the current standard of care which is Priorix™ administered at 9 months of age followed by concomitant administration of Priorix™ with Varilrix™ at 15 months of age in a measles endemic environment such as India.
Interventions
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Months to 10 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study. * Male or female subjects between and including 9 and 10 months of age at the time of the first vaccination. * Written informed consent obtained from the the parent or guardian of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Chronic administration 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 starting 30 days prior to administration of any dose of the study vaccine, up to 42 days after the vaccine dose with the exception of hepatitis A vaccine and oral poliovirus vaccine . * 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-registered product. * Previous vaccination against measles, mumps, rubella and varicella. * History of measles, mumps, rubella and/or varicella diseases. * Known exposure to measles, mumps, rubella and/or varicella 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. * A family history of congenital or hereditary immunodeficiency. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines including neomycin. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Axillary temperature \> 37.5°C (99.5°F) / Rectal temperature \> 38°C (100.4°F). * Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * Presence of a susceptible high-risk person in the same household during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | At 42 - 56 days after the second vaccination dose at week 30 | Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose | Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs). |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2) | 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/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Approximately 42 to 56 days after the first vaccine dose at week 6 | Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively. |
| Number of Subjects Reporting Any, Grade 3 and Related Rash | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) | Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (\>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination |
| Number of Subjects Reporting Any Unsolicited Adverse Event | Within 43-day (Days 0-42) after the first and second vaccination dose | An unsolicited Adverse Event (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. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event. |
| Number of Subjects With Serious Adverse Events (SAEs) | From the first study dose up to study end (Month 0 to Month 7.5 approximately) | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Any, Grade 3 and Related Fever | During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2) | Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever \> 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination. |
Countries
India
Participant flow
Pre-assignment details
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.
Participants by arm
| Arm | Count |
|---|---|
| Priorix-Tetra Group Subjects received 2 doses of Priorix-Tetra® vaccine, 1 at Day 0 and 1 at Month 6, administered subcutaneously in the left anterolateral thigh. | 180 |
| Priorix/ Priorix-Tetra Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix-Tetra® vaccine at Month 6, both administered subcutaneously in the left anterolateral thigh. | 180 |
| Control Group Subjects received 1 dose of Priorix™ vaccine at Day 0 and 1 dose of Priorix™ vaccine co-administered with Varilirix™ vaccine at Month 6, administered subcutaneously in the left and right anterolateral thigh. | 90 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Father - serious health problem | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 8 | 5 |
| Overall Study | Migrated/moved from study area | 12 | 10 | 2 |
| Overall Study | Parents personal problem | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 3 | 0 |
| Overall Study | Subject eliminated (other vaccine) | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 | 2 |
Baseline characteristics
| Characteristic | Priorix-Tetra Group | Priorix/ Priorix-Tetra Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 9 Months STANDARD_DEVIATION 0 | 9 Months STANDARD_DEVIATION 0.11 | 9 Months STANDARD_DEVIATION 0 | 9 Months STANDARD_DEVIATION 0.07 |
| Race/Ethnicity, Customized American Indian or Alaskan native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian - central/ south Asian heritage | 177 Participants | 175 Participants | 88 Participants | 440 Participants |
| Race/Ethnicity, Customized Asian - south east Asian heritage | 2 Participants | 5 Participants | 2 Participants | 9 Participants |
| Sex: Female, Male Female | 79 Participants | 89 Participants | 49 Participants | 217 Participants |
| Sex: Female, Male Male | 101 Participants | 91 Participants | 41 Participants | 233 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 180 | 0 / 180 | 0 / 90 |
| other Total, other adverse events | 114 / 180 | 116 / 180 | 55 / 90 |
| serious Total, serious adverse events | 7 / 180 | 6 / 180 | 0 / 90 |
Outcome results
Primary
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies
Seroconversion was defined as the appearance of antibodies \[i.e. concentration/titre greater than or equal to (≥) the cut-off value\] in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 milli-international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and for immunoglobulin G (IgG) varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: At 42 - 56 days after the second vaccination dose at week 30
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 149 Participants |
| Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 149 Participants |
| Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 150 Participants |
| Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 138 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 141 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 153 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 152 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 152 Participants |
| Control Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 69 Participants |
| Control Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 72 Participants |
| Control Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 73 Participants |
| Control Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 72 Participants |
Comparison: Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.95% CI: [-2.48, 5.02]
Comparison: Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.95% CI: [-2.52, 5.09]
Comparison: Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.95% CI: [-2.52, 5.09]
Comparison: Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-rubella seroconversion rates.95% CI: [-2.51, 5.02]
Comparison: Non-inferiority of 2 doses of Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.95% CI: [1.37, 11.57]
Comparison: Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-measles seroconversion rates.95% CI: [-2.46, 5.09]
Comparison: Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-mumps seroconversion rates.95% CI: [-2.48, 5.09]
Comparison: Non-inferiority of Priorix™ vaccine followed by Priorix-Tetra® vaccine compared to Priorix™ vaccine followed by Priorix™ vaccine co-administered with Varilrix™ vaccine in terms of anti-varicella seroconversion rates.95% CI: [-1.59, 10.29]
Secondary
Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses
Antibody concentrations were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs).
Time frame: At 42 - 56 days after the first (at Week 6) and second (at Week 30) vaccination dose
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 6 | 2013.6 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 6 | 991.9 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 6 | 45.4 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 6 | 120.5 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 30 | 4471.3 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 30 | 6428 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 30 | 148.4 mIU/mL |
| Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 30 | 5318.5 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 6 | 63.8 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 30 | 164.8 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 6 | 2.2 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 30 | 3358.7 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 30 | 10108.5 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 6 | 1180.4 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 6 | 746.6 mIU/mL |
| Priorix/ Priorix-Tetra Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 30 | 198 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 6 | 62 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 6 | 775.1 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 6 | 1200 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 6 | 2.2 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella; Week 30 | 173 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps; Week 30 | 4925.3 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles; Week 30 | 2495 mIU/mL |
| Control Group | Antibody Concentrations Against Measles, Mumps, Rubella and Varicella Viruses | IgG varicella antibodies; Week 30 | 128 mIU/mL |
Secondary
Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies
Seroconversion was defined as the appearance of antibodies (i.e. concentration/titre ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and for IgG varicella antibodies 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: Approximately 42 to 56 days after the first vaccine dose at week 6
Population: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all eligible subjects for whom pre-vaccination and post-vaccination serology results were available for antibodies against at least one antigen.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 138 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 124 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 147 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 130 Participants |
| Priorix/ Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 4 Participants |
| Priorix/ Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 135 Participants |
| Priorix/ Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 151 Participants |
| Priorix/ Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 128 Participants |
| Control Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | IgG varicella antibodies ≥ 1:4 | 1 Participants |
| Control Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-mumps ≥ 231 U/ML | 60 Participants |
| Control Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-rubella ≥ 4 IU/mL | 73 Participants |
| Control Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella and Varicella Antibodies | Anti-measles ≥ 150 mIU/mL | 63 Participants |
Secondary
Number of Subjects Reporting Any and Grade 3 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/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 4-day (Days 0-3) post-vaccination period following each dose (Dose 1 and Dose 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 1 | 20 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 1 | 15 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 1 | 8 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 2 | 9 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 2 | 10 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 2 | 3 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 2 | 9 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 1 | 12 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 2 | 10 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 2 | 6 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 2 | 6 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 1 | 8 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 1 | 5 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 1 | 3 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 2 | 3 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 1 | 9 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 1 | 3 Participants |
| Control Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 2 | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Fever
Any fever was defined as fever ≥ 38.0°C and grade 3 fever was defined as fever \> 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 1 | 76 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 1 | 11 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 1 | 53 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 2 | 41 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 2 | 2 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 2 | 22 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 2 | 21 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 1 | 70 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 2 | 37 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 2 | 6 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 1 | 5 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 1 | 48 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 1 | 1 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 1 | 15 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 2 | 10 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 2 | 22 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 1 | 27 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 2 | 2 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Rash
Any rash was defined as incidence of a rash regardless of intensity grade or relationship to vaccination and grade 3 rash greater than (\>) 150 lesions. Related rash was defined as rash assessed by the investigator as causally related to the vaccination
Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 1 | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 1 | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 1 | 2 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 2 | 1 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Related Rash; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Any Rash; Dose 1 | 1 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Rash | Grade 3 Rash; Dose 2 | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 meningism and parotid gland swelling = meningism/parotid gland swelling which prevented normal everyday activities. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period following each dose (Dose 1 and Dose 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects with the symptom sheet filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 2 | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 2 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 1 | 0 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid gland swelling; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid gland swelling; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Meningism; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Meningism; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 2 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Meningism; Dose 1 | 0 Participants |
| Control Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid gland swelling; Dose 2 | 0 Participants |
Secondary
Number of Subjects Reporting Any Unsolicited Adverse Event
An unsolicited Adverse Event (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. Any was defined as an AE reported in addition to those solicited during the clinical study. Also any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time frame: Within 43-day (Days 0-42) after the first and second vaccination dose
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 2 | 19 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 1 | 37 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 1 | 39 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 2 | 18 Participants |
| Control Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 1 | 18 Participants |
| Control Group | Number of Subjects Reporting Any Unsolicited Adverse Event | Any AE(s); Dose 2 | 11 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or congenital anomaly/birth defect in the offspring of a study subject.
Time frame: From the first study dose up to study end (Month 0 to Month 7.5 approximately)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Priorix-Tetra Group | Number of Subjects With Serious Adverse Events (SAEs) | 7 Participants |
| Priorix/ Priorix-Tetra Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs) | 0 Participants |