Measles, Mumps, Rubella, Varicella
Conditions
Keywords
Working seed virus, Rubella, Mumps, Varicella, Combined measles-mumps-rubella-varicella vaccine, Pediatric immunization, Measles
Brief summary
This study is undertaken to generate clinical data on GSK Biologicals' combined measles-mumps-rubella-varicella vaccine manufactured with measles and rubella obtained from newly established working seed viruses which are one passage further than the current working seed viruses. The measles-mumps-rubella-varicella vaccine manufactured with the current working seed viruses will serve as comparator. A seed lot system is a system according to which successive batches of a vaccine are derived from the same master seed virus. For routine production, a working seed lot is prepared from the master seed virus.
Interventions
BIOLOGICALPriorix-Tetra (combined measles-mumps-rubella-varicella vaccine)
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
BIOLOGICALGSK Biologicals' 208136, new formulation
Vaccine will be administered subcutaneously in the left upper arm (deltoid region)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
11 Months to 21 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 (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study. * A male or female between, and including, 11 and 21 months of age (e.g. from age 11months until the day before age 22 months) at the time of the first vaccination. * Written informed consent obtained from the parent or guardian of the subject after they have been advised on the risks and benefits of the study in a language they clearly understand, and before performance of any study procedure. * Free of obvious healthy problems as established by medical history and clinical examination before entering into the study.
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. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period. * Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after each study vaccine dose with the exception of oral polio vaccine (OPV) which can be given at any time and routine inactivated vaccines such as pneumococcal, meningococcal or Haemophilus influenzae type b conjugate vaccines, inactivated influenza or diphtheria/tetanus containing vaccines which can be administered up to eight days before each study vaccine dose. * Previous vaccination against measles, mumps, rubella and/or varicella. * History of measles, mumps, rubella and/or varicella/zoster diseases. * Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start. * Any confirmed or suspected immunosuppressive or immunodeficient condition, 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 vaccine(s), including systemic hypersensitivity to neomycin. * Major congenital defects or serious chronic illness. * History of any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Rectal temperature ≥38°C or axillary temperature \>=37.5°C at the time of vaccination. * Residence in the same household as a high risk person e.g.: * New-born infants (0-4 weeks of age) * Pregnant women who have a negative history of chickenpox * Persons with known immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | At 42-56 days after the first dose of study vaccine (Week 6) | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | At 42-56 days after the first and second dose of study vaccine(s). | Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Within 4 days after each vaccination (Days 0-3) | 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 and Grade 3 Solicited General Symptoms | Within 43 days (Days 0-42) after each vaccination | Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities. |
| Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | At 42-56 days after the second dose of study vaccine (Week 18) | Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively. |
| Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Within 43 days (Days 0-42) after each vaccination | Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination. |
| Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Within 43 days (Days 0-42) after first vaccination dose | 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. Any was defined as an adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination. |
| Number of Subjects With Serious Adverse Events (SAEs) | From first study dose (Day 0) until study end (Week 18) | Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject. |
| Number of Subjects Reporting Any, Grade 3 and Related Fever | Within 43 days (Days 0-42) after each vaccination | Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (\>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination. |
Countries
Singapore, Taiwan
Participant flow
Pre-assignment details
Out of the 501 enrolled participants, 3 were not administered any vaccine and hence were not considered as having started the study.
Participants by arm
| Arm | Count |
|---|---|
| Priorix-Tetra New WS Group Subjects received 2 doses of Priorix-Tetra vaccine formulated with new measles and rubella working seeds at Day 0 and Week 12. | 332 |
| Priorix-Tetra Current WS Group Subjects received 2 doses of Priorix-Tetra vaccine manufactured with current working seed virus at Day 0 and Week 12. | 166 |
| Total | 498 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Disclaimer/ Withdrawal caused by H1N1 | 1 | 0 |
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Migrated/ moved from study area | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Subject difficulties with blood drawing | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Priorix-Tetra New WS Group | Priorix-Tetra Current WS Group | Total |
|---|---|---|---|
| Age, Continuous | 13 Months STANDARD_DEVIATION 1.94 | 12.9 Months STANDARD_DEVIATION 1.7 | 12.97 Months STANDARD_DEVIATION 1.86 |
| Race/Ethnicity, Customized Asian - East Asian heritage | 165 Participants | 83 Participants | 248 Participants |
| Race/Ethnicity, Customized Asian - South East Asian heritage | 162 Participants | 81 Participants | 243 Participants |
| Race/Ethnicity, Customized Unspecified | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized White - Caucasian / European heritage | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Female | 166 Participants | 84 Participants | 250 Participants |
| Sex: Female, Male Male | 166 Participants | 82 Participants | 248 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 332 | 0 / 166 |
| other Total, other adverse events | 246 / 332 | 117 / 166 |
| serious Total, serious adverse events | 27 / 332 | 12 / 166 |
Outcome results
Primary
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 milli international units per milliliter (mIU/mL), 231 units per milliliter (U/mL), 4 international units per milliliter (IU/mL) and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: At 42-56 days after the first dose of study vaccine (Week 6)
Population: The According-to-protocol (ATP) cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received vaccine according to their random assignment, who had not received a vaccine forbidden in the protocol and for whom pre/ post-vaccination serology results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-measles ≥ 150 mIU/mL | 312 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-mumps ≥ 231 U/ML | 279 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-rubella ≥ 4 IU/mL | 313 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | IgG varicella antibodies ≥ 1:4 dilution | 284 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | IgG varicella antibodies ≥ 1:4 dilution | 131 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-measles ≥ 150 mIU/mL | 157 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-rubella ≥ 4 IU/mL | 157 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies Greater Than or Equal to (≥) the Cut-off Value. | Anti-mumps ≥ 231 U/ML | 142 Participants |
95% CI: [-2.29, 1.76]
95% CI: [-6.14, 5.58]
95% CI: [-1.78, 2.08]
95% CI: [0.72, 10.34]
Secondary
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Antibody titers were summarized by geometric mean titers (GMTs) with their 95% confidence intervals.
Time frame: At 42-56 days after the first and second dose of study vaccine(s).
Population: The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Measles (mIU/mL); Dose 1 | 3291.2 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Mumps (U/mL); Dose 1 | 924.4 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Rubella (IU/mL); Dose 1 | 71.7 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Varicella (1/dil); Dose 1 | 104.8 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Measles (mIU/mL); Dose 2 | 4247.6 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Mumps (U/mL); Dose 2 | 3379.5 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Rubella (IU/mL); Dose 2 | 125.7 Titres |
| Priorix-Tetra New WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Varicella (1/dil); Dose 2 | 6570.6 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Varicella (1/dil); Dose 2 | 5134.8 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Measles (mIU/mL); Dose 1 | 3460.1 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Measles (mIU/mL); Dose 2 | 4297.1 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Mumps (U/mL); Dose 1 | 994.4 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Rubella (IU/mL); Dose 2 | 115.2 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Rubella (IU/mL); Dose 1 | 66.6 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Mumps (U/mL); Dose 2 | 3216.2 Titres |
| Priorix-Tetra Current WS Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-Varicella (1/dil); Dose 1 | 69.6 Titres |
Secondary
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms
Assessed solicited general symptoms were meningism and parotid gland swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 meningism and parotid gland swelling = meningism/ parotid gland swelling which prevented normal everyday activities.
Time frame: Within 43 days (Days 0-42) after each vaccination
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 New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Meningism; Dose 1 | 2 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Meningism; Dose 1 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Parotid gland; Dose 1 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Parotid gland; Dose 1 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Meningism; Dose 2 | 2 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Meningism; Dose 2 | 1 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Parotid gland; Dose 2 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Parotid gland; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Parotid gland; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Meningism; Dose 1 | 1 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Meningism; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Meningism; Dose 1 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Parotid gland; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Any Parotid gland; Dose 1 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Meningism; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms | Grade 3 Parotid gland; Dose 1 | 0 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: Within 4 days after each vaccination (Days 0-3)
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 New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 1 | 62 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 1 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 1 | 92 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 1 | 2 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 1 | 22 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 1 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 2 | 46 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 2 | 0 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 2 | 79 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 2 | 4 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 2 | 37 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 2 | 1 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 2 | 25 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 1 | 28 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain; Dose 2 | 24 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 1 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 2 | 5 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 1 | 44 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness; Dose 1 | 3 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 2 | 0 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling; Dose 1 | 11 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness; Dose 2 | 43 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling; Dose 1 | 0 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Fever
Any fever was defined as fever greater than or equal to (≥) 38.0 Celsius degrees (°C) and grade 3 fever greater than (\>) 39.5°C after vaccination. Related fever was defined as fever assessed by the investigator as related to the vaccination.
Time frame: Within 43 days (Days 0-42) after each vaccination
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 New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 1 | 54 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 2 | 115 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 1 | 231 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 2 | 31 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 1 | 160 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 2 | 29 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 1 | 70 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 1 | 104 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 1 | 23 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Related temperature; Dose 2 | 28 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Any temperature; Dose 2 | 62 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Fever | Grade 3 temperature; Dose 2 | 13 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (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. Any was defined as an adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 43 days (Days 0-42) after first 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 New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Any AE(s) | 165 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Grade 3 AE(s) | 8 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Related AE(s) | 21 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Any AE(s) | 73 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Grade 3 AE(s) | 5 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Related AE(s) | 8 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (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. Any was defined as an adverse event (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. Grade 3 was defined as an event that prevented normal activity and Related was defined as an event assessed by the investigator as causally related to the study vaccination.
Time frame: Within 43 days (Days 86-128) after 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 New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Any AE(s) | 146 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Grade 3 AE(s) | 6 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Related AE(s) | 10 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Grade 3 AE(s) | 6 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Any AE(s) | 76 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Event (AEs) | Related AE(s) | 6 Participants |
Secondary
Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes
Rash was defined as: 1) measles/ rubella rashes (macular or maculo-papular rashes): presence of macules, discolored small patches or spots of the skin, neither elevated nor depressed below the skin's surface; 2) varicella rash (maculo-papulo-vesicular): simultaneous presence of macules, papules and vesicles raised above the skin's surface; 3) other types of rash (heat rash, diaper rash etc.). Any rash = occurrence of rash regardless of intensity grade or relationship to vaccination Grade 3 rash ≥ 150 lesions and Related = rash assessed by the investigator as related to the vaccination.
Time frame: Within 43 days (Days 0-42) after each vaccination
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 New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Any, rash type; Dose 1 | 88 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Grade 3 rash type; Dose 1 | 9 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Related rash type; Dose 1 | 37 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Any, rash type; Dose 2 | 40 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Grade 3 rash type; Dose 2 | 6 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Related rash type; Dose 2 | 12 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Grade 3 rash type; Dose 2 | 1 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Any, rash type; Dose 1 | 42 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Any, rash type; Dose 2 | 17 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Grade 3 rash type; Dose 1 | 6 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Related rash type; Dose 2 | 7 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Reporting Any (Local or General), Grade 3 and Related Rashes | Related rash type; Dose 1 | 23 Participants |
Secondary
Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value.
Seroconversion was defined as the appearance of antibodies in the serum of subjects seronegative before vaccination. The cut-off values for seroconversion was 150 mIU/mL, 231 U/mL, 4 IU/mL and 1:4 dilution for measles, mumps, rubella and varicella, respectively.
Time frame: At 42-56 days after the second dose of study vaccine (Week 18)
Population: The ATP cohort for immunogenicity included all eligible subjects who were seronegative at baseline to at least one vaccine antigen, who had received the comparator vaccine according to their random assignment, who had not received a vaccine not specified/ forbidden in the protocol and for whom pre/ post-vaccination serology results were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-measles ≥ 150 mIU/mL | 308 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-mumps ≥ 231 U/ML | 307 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-rubella ≥ 4 IU/mL | 308 Participants |
| Priorix-Tetra New WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | IgG varicella antibodies ≥ 1:4 dilution | 286 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | IgG varicella antibodies ≥ 1:4 dilution | 138 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-measles ≥ 150 mIU/mL | 156 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-rubella ≥ 4 IU/mL | 156 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Antibodies ≥ the Cut-off Value. | Anti-mumps ≥ 231 U/ML | 155 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/ incapacity or is a congenital anomaly/ birth defect in the offspring of a study subject.
Time frame: From first study dose (Day 0) until study end (Week 18)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Priorix-Tetra New WS Group | Number of Subjects With Serious Adverse Events (SAEs) | 27 Participants |
| Priorix-Tetra Current WS Group | Number of Subjects With Serious Adverse Events (SAEs) | 12 Participants |