Rubella, Varicella, Measles, Mumps
Conditions
Keywords
safety, healthy, conjugated, immunogenicity, children, MenC vaccine, MMRV vaccine
Brief summary
The purpose of this study is to assess the immunogenicity and safety of GSK Biologicals' investigational measles, mumps, rubella and varicella (MMRV) vaccine (GSK208136, PriorixTetra™) when co-administered along with conjugated Meningococcal C (MenC) vaccine (Meningitec®, Nuron Biotechs' Vaccine) in healthy children.
Interventions
BIOLOGICALPriorixTetra™
One dose administered subcutaneously
BIOLOGICALMeningitec
One dose administered intramuscularly
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Months to 15 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects who the investigator believes that parent(s)/Legally Acceptable Representatives (LAR) can and will comply with the requirements of the protocol. * A male or female between, and including, 13 and 15 months of age at the time of the first vaccination. * Written informed consent obtained from the parent(s)/ LAR of the subject. * Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion criteria
* Child in care. * Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the 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 the study vaccination/s and ending 42 days after the vaccination/s (at Visit 2), with the exception of inactivated influenza (flu) vaccine, which may be given at any time during the study, including the day of study vaccination/s. * 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. * Previous vaccination against measles, mumps, rubella, varicella/ herpes zoster and/or N. meningitidis serogroup C. * History of measles, mumps, rubella, varicella and/or N. meningitidis serogroup C diseases. * Known exposure to measles, mumps, rubella and or varicella starting 30 days prior to enrolment. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * Major congenital defects or serious chronic illness. * Acute disease and/or fever at the time of enrollment. * Documented human immunodeficiency virus (HIV) positive subject. * Any contraindications as stated in the Summary of Product Characteristics. * Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | At 42 days after vaccination | Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively. |
| Number of Seroprotected Subjects for rSBA-MenC Antibodies | At 42 days after vaccination | Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Fever Per Half Degree | During the 43-day (Days 0-42) post-vaccination period | Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever \> 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination. |
| Number of Subjects Reporting Any, Localised and Generalised Rashes | Within the 43-day (Days 0-42) post-vaccination period | Rash/exanthem 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 or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = \> 150 lesions. |
| Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | During the 4-day (Days 0-3) post-vaccination period | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = Cried when limb is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine. |
| Number of Subjects With Serious Adverse Events (SAEs) | Throughout study period (from Day 0 to approximately Month 4) | SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | At Day 42 after vaccination | Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | Within 43 days (Days 0-42) after each vaccination | 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 reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | During the 15-day (Days 0-14) post-vaccination period | Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination. |
Countries
Italy
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 + Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. | 351 |
| Priorix-Tetra Group Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. | 183 |
| Meningitec Group Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm. | 182 |
| Total | 716 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse event, non-fatal | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 8 | 3 | 3 |
| Overall Study | Migrated/moved from study area | 0 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 | 8 |
Baseline characteristics
| Characteristic | Priorix-Tetra + Meningitec Group | Priorix-Tetra Group | Meningitec Group | Total |
|---|---|---|---|---|
| Age, Continuous | 13.4 Months STANDARD_DEVIATION 0.6 | 13.4 Months STANDARD_DEVIATION 0.6 | 13.4 Months STANDARD_DEVIATION 0.7 | 13.4 Months STANDARD_DEVIATION 0.63 |
| Sex: Female, Male Female | 167 Participants | 85 Participants | 88 Participants | 340 Participants |
| Sex: Female, Male Male | 184 Participants | 98 Participants | 94 Participants | 376 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 327 / 351 | 158 / 183 | 146 / 182 |
| serious Total, serious adverse events | 6 / 351 | 4 / 183 | 2 / 182 |
Outcome results
Primary
Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus
Seroconversion was defined as the appearance of antibodies (i.e. concentration/titer ≥ the cut-off value) in the serum of subjects seronegative before vaccination. The cut-off values for serocoversion were 150 mIU/mL, 231 U/mL, 4 IU/mL and 25 mIU/mL for measles, mumps, rubella and varicella, respectively.
Time frame: At 42 days after vaccination
Population: The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-measles ≥ 150 mIU/mL | 305 Participants |
| Priorix-Tetra + Meningitec Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-mumps ≥ 231 U/ML | 292 Participants |
| Priorix-Tetra + Meningitec Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-rubella ≥ 4 IU/mL | 309 Participants |
| Priorix-Tetra + Meningitec Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-varicella ≥ 25 mIU/mL | 299 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-varicella ≥ 25 mIU/mL | 159 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-measles ≥ 150 mIU/mL | 162 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-rubella ≥ 4 IU/mL | 164 Participants |
| Priorix-Tetra Group | Number of Seroconverted Subjects for Measles, Mumps, Rubella, and Varicella Virus | Anti-mumps ≥ 231 U/ML | 151 Participants |
Comparison: Immune response for anti-measles antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-measles seroconversion rates (SCRs) at Day 42 after dose 1.95% CI: [-1.82, 2.78]
Comparison: Immune response for anti-mumps antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-mumps seroconversion rates (SCRs) at Day 42 after dose 1.95% CI: [-3.04, 6.67]
Comparison: Immune response for anti-rubella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-rubella seroconversion rates (SCRs) at Day 42 after dose 1.95% CI: [-1.23, 2.29]
Comparison: Immune response for anti-varicella antibodies~Non-inferiority of Priorix-Tetra™ vaccine co-administered with Meningitec® conjugate vaccine compared to the first dose of Priorix-Tetra™ vaccine alone with respect to anti-varicella seroconversion rates (SCRs) at Day 42 after dose 1.95% CI: [-1.87, 2.03]
Primary
Number of Seroprotected Subjects for rSBA-MenC Antibodies
Seroprotection was defined as the appearance of rSBA-MenC antibody titer ≥ 1:8.
Time frame: At 42 days after vaccination
Population: The analysis was performed on all eligible subjects with post-dose 1 serology results available for at least one antigen in this analysis, included in the ATP cohort for immunogenicity post-dose 1, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood draw.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Seroprotected Subjects for rSBA-MenC Antibodies | 286 Participants |
| Priorix-Tetra Group | Number of Seroprotected Subjects for rSBA-MenC Antibodies | 142 Participants |
Comparison: Immune response for rSBA-MenC antibodies~Non-inferiority of Meningitec® conjugate vaccine co-administered with Priorix-Tetra™ compared to Meningitec® conjugate vaccine alone with respect to rabbit complement serum bactericidal assay (rSBA-MenC) antibody seroprotection rates (SPRs) at Day 42 after vaccination.95% CI: [-3.39, 2.24]
Secondary
Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses
Antibody titers were summarized by geometric mean concentrations (GMCs) with their 95% confidence intervals (CIs) for the following cut-offs: ≥ 150 mIU/mL, ≥ 231 U/mL, ≥ 4 IU/mL and ≥ 25 mIU/mL for anti-measles, anti-mumps, anti-rubella and anti-varicella, respectively.
Time frame: At Day 42 after vaccination
Population: The analysis was performed on the ATP cohort for immunogenicity post-dose 1 which included all eligible subjects with post-dose 1 serology results available for at least one antigen, who received medication/vaccine and who had no underlying medical condition forbidden in the protocol before the Visit 2 last blood drawn.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles | 2943.6 Titers |
| Priorix-Tetra + Meningitec Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps | 1530.7 Titers |
| Priorix-Tetra + Meningitec Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella | 40.2 Titers |
| Priorix-Tetra + Meningitec Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-varicella | 156.3 Titers |
| Priorix-Tetra Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-varicella | 145.2 Titers |
| Priorix-Tetra Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-measles | 3158.5 Titers |
| Priorix-Tetra Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-rubella | 44.9 Titers |
| Priorix-Tetra Group | Antibody Titers Against Measles, Mumps, Rubella and Varicella Viruses | Anti-mumps | 1591.3 Titers |
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 is moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. This outcome measure concerns subjects in Priorix-Tetra + Meningitec Group and Priorix-Tetra Group only. Subjects in Priorix-Tetra Group did not receive Meningitec® vaccine.
Time frame: During the 4-day (Days 0-3) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Meningitec | 9 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Priorix-Tetra | 92 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Priorix-Tetra | 47 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Meningitec | 79 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Meningitec | 4 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Priorix-Tetra | 78 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Priorix-Tetra | 1 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Meningitec | 100 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Meningitec | 9 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Priorix-Tetra | 4 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Meningitec | 68 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Priorix-Tetra | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Redness, Priorix-Tetra | 41 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Priorix-Tetra | 2 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Redness, Priorix-Tetra | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Priorix-Tetra | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Swelling, Priorix-Tetra | 20 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms | Any Pain, Priorix-Tetra | 31 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 15-day (Days 0-14) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 128 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 178 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 138 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness | 158 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness | 187 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness | 30 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 25 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 148 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 16 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 12 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 12 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness | 13 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 75 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 99 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 89 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness | 82 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness | 104 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 67 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Irritability/Fussiness | 84 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability/Fussiness | 7 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Irritability/Fussiness | 64 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite | 60 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness | 56 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness | 6 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite | 5 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite | 43 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness | 46 Participants |
Secondary
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were Parotid / salivary gland swelling and suspected signs of meningism / febrile convulsions. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 parotid / salivary gland swelling = swelling with accompanying general symptoms and Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid / salivary gland swelling | 3 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid / salivary gland swelling | 0 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid / salivary gland swelling | 3 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Suspected signs of meningism | 1 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Suspected signs of meningism | 0 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Suspected signs of meningism | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Suspected signs of meningism | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid / salivary gland swelling | 4 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Suspected signs of meningism | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Suspected signs of meningism | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid / salivary gland swelling | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid / salivary gland swelling | 3 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Parotid / salivary gland swelling | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Parotid / salivary gland swelling | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Related Suspected signs of meningism | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Suspected signs of meningism | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Any Parotid / salivary gland swelling | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Suspected signs of meningism | 0 Participants |
Secondary
Number of Subjects Reporting Any, Localised and Generalised Rashes
Rash/exanthem 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 or other types of rash (heat rash, diaper rash etc.). Any rash = no lesions and grade 3 = \> 150 lesions.
Time frame: Within the 43-day (Days 0-42) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets for rash completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Other site rash | 40 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Measles/Rubella like rash | 25 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Grade 3 rash | 0 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, With fever rash | 23 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Grade 3 rash | 2 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, With fever rash | 59 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Varicella like rash | 2 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Related rash | 39 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Localised or generalised rash | 91 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Measles/Rubella like rash | 15 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Varicella like rash | 4 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Related rash | 66 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Grade 3 rash | 2 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, With fever rash | 38 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Any rash | 43 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Measles/Rubella like rash | 40 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Any rash | 54 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Administration site rash | 3 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Varicella like rash | 6 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Related rash | 31 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Measles/Rubella like rash | 13 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Varicella like rash | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Measles/Rubella like rash | 16 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Grade 3 rash | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Related rash | 22 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Any rash | 13 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Administration site rash | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Other site rash | 12 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, With fever rash | 10 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Varicella like rash | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Measles/Rubella like rash | 3 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Localised or generalised rash | 41 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Grade 3 rash | 0 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Related rash | 4 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Any rash | 28 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, With fever rash | 20 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Varicella like rash | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, With fever rash | 30 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Grade 3 rash | 1 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Related rash | 18 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Measles/Rubella like rash | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Related rash | 6 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Any rash | 9 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Varicella like rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Any rash | 6 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Related rash | 6 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Related rash | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, With fever rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Grade 3 rash | 2 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Grade 3 rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Generalised, Varicella like rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Varicella like rash | 0 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Measles/Rubella like rash | 2 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, Localised or generalised rash | 15 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, With fever rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Measles/Rubella like rash | 2 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Other site rash | 6 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Any, With fever rash | 2 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Grade 3 rash | 1 Participants |
| Meningitec Group | Number of Subjects Reporting Any, Localised and Generalised Rashes | Localised, Administration site rash | 3 Participants |
Secondary
Number of Subjects Reporting Fever Per Half Degree
Any fever = fever ≥ 38.0°C on rectal setting, grade 3 fever = fever \> 39.5 °C and related = fever assessed by the investigator as causally related to study vaccination.
Time frame: During the 43-day (Days 0-42) post-vaccination period
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered, on subjects with their symptom sheets completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Grade 3 temperature | 15 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Any temperature | 159 Participants |
| Priorix-Tetra + Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Related temperature | 178 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Fever Per Half Degree | Grade 3 temperature | 9 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Fever Per Half Degree | Any temperature | 86 Participants |
| Priorix-Tetra Group | Number of Subjects Reporting Fever Per Half Degree | Related temperature | 84 Participants |
| Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Any temperature | 46 Participants |
| Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Related temperature | 28 Participants |
| Meningitec Group | Number of Subjects Reporting Fever Per Half Degree | Grade 3 temperature | 4 Participants |
Secondary
Number of Subjects With Any 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 reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 43 days (Days 0-42) after each vaccination
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 97 Participants |
| Priorix-Tetra Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 61 Participants |
| Meningitec Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 41 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: Throughout study period (from Day 0 to approximately Month 4)
Population: The analysis was performed on the Total Vaccinated cohort which included all subjects with study vaccine administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Priorix-Tetra + Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| Priorix-Tetra Group | Number of Subjects With Serious Adverse Events (SAEs) | 4 Participants |
| Meningitec Group | Number of Subjects With Serious Adverse Events (SAEs) | 2 Participants |