Varicella, Chickenpox Vaccines
Conditions
Brief summary
An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease. This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination. Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.
Interventions
BIOLOGICALPriorix-tetra™
2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group
BIOLOGICALPriorix™
2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group
BIOLOGICALVarilrix™
1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
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 22 Months
Healthy volunteers
Yes
Inclusion criteria
* Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study. * Male or female subject between 12 and 22 months of age at the time of the first vaccination. * Subjects free of obvious health problems, as established by medical history and physical examination before entering the study. * Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure. * Subjects whose parents/guardians have direct access to telephone/mobile phone. * Subjects: 1. with at least one sibling (with negative history of varicella disease/vaccination) at home, or 2. attending day care center, or 3. attending childminders, i.e. someone taking care of several children, or 4. who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes.
Exclusion criteria
* Previous vaccination against measles, mumps, rubella and/or varicella. * History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases. * Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study. * 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 within three months prior to the first vaccine dose or planned administration during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical. * Family history of congenital or hereditary immunodeficiency. * History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin. * Major congenital defects or serious chronic illness. * Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella. * History of any neurologic disorders or seizures. * Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period. Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase A: Number of Subjects With Confirmed Varicella Case | From 42 days post dose 2 until the end of Phase A | Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Phase A: Number of Subjects With Probable or Confirmed Varicella Case | From 42 days post dose 2 until the end of Phase A | Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case. |
| Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL). |
| Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Seronegative (S-) = Subjects with antibody concentration less than (\<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. |
| Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL). |
| Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Seronegative (S-) = Subjects with antibody concentration \< 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. |
| Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL). |
| Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Seronegative (S-) = Subjects with antibody concentration \< 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. |
| Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL). |
| Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | At Day 0, Day 42, Day 84, Year 1 and Year 2 time points | Seronegative (S-) = Subjects with antibody concentration \< 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination. |
| Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster | From Day 0 until the end of Phase A (Year 2) | The number of subjects with confirmed cases of herpes zoster is reported. |
| Phase A: Number of Subjects Reporting Fever | Within 43 days (Day 0-42) post-vaccination period following each dose | All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice. |
| Phase A: Number of Subjects Reporting Solicited Local Symptoms | 4 days post-vaccination period following each dose | Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (\>) 20 mm. |
| Phase A: Number of Subjects Reporting Meningism | Within 43 days (Day 0-42) post-vaccination period following each dose | Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination. |
| Phase A: Number of Subjects Reporting Parotitis | Within 43 days (Day 0-42) post-vaccination period following each dose | Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study. |
| Phase A: Number of Subjects Reporting Rash | Within 43 days (Day 0-42) post-vaccination period following each dose | Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = \> 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination. |
| Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Within 43 days (Day 0-42) post-vaccination period following each dose | Any = Occurrence of meningism including febrile convulsions regardless of intensity grade. |
| Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Within 43 days (Day 0-42) post-vaccination period following each dose | Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. |
| Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case | From 42 days post dose 2 until the end of Phase A | Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale). |
| Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | During Phase A (from Day 0 up to Year 2) | Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable). |
| Phase B: Number of Subjects With Confirmed Varicella Case | From the beginning of Phase B (Year 2) up to study end (Year 10) | Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. |
| Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case | From the beginning of Phase B (Year 2) up to study end (Year 10) | Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale). |
| Phase B: Number of Subjects With Probable or Confirmed Varicella Case | From the beginning of Phase B (Year 2) up to study end (Year 10) | Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case. |
| Phase B: Characteristics of Varicella Cases | From the beginning of Phase B (Year 2) up to study end (Year 10) | Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity. |
| Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | At Year 4, Year 6, Year 8 and Year 10 time points | Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL). |
| Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | At Year 4, Year 6, Year 8 and Year 10 time points | The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination. |
| Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | At Year 4, Year 6, Year 8 and Year 10 time points | Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL). |
| Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | At Year 4, Year 6, Year 8 and Year 10 time points | The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination. |
| Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | At Year 4, Year 6, Year 8 and Year 10 time points | Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL). |
| Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | At Year 4, Year 6, Year 8 and Year 10 time points | The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination. |
| Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | At Year 4, Year 6, Year 8 and Year 10 time points | Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL). |
| Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | At Year 4, Year 6, Year 8 and Year 10 time points | The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination. |
| Phase B: Characteristics of Zoster Cases | From 6 weeks after Dose 2 until study end (Year 10) | Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity. |
| Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs) | From the beginning of Phase B (Year 2) up to study end (Year 10) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination. |
| Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | During Phase B | Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable). |
| Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs) | From Day 0 until the end of Phase A (Year 2) | SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination. |
Countries
Czechia, Greece, Italy, Lithuania, Norway, Poland, Romania, Russia, Slovakia, Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| MMRV Group Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). | 2,489 |
| OKAH Group Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm. | 2,487 |
| MMR Group Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2). | 827 |
| Total | 5,803 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 10 | 6 | 3 |
| Overall Study | Others | 1,064 | 1,066 | 356 |
Baseline characteristics
| Characteristic | MMRV Group | OKAH Group | MMR Group | Total |
|---|---|---|---|---|
| Age, Continuous | 14.3 Months STANDARD_DEVIATION 2.5 | 14.2 Months STANDARD_DEVIATION 2.5 | 14.2 Months STANDARD_DEVIATION 2.5 | 14.2 Months STANDARD_DEVIATION 2.5 |
| Race/Ethnicity, Customized Race American hispanic | 1 Participants | 5 Participants | 2 Participants | 8 Participants |
| Race/Ethnicity, Customized Race Arabic/north african | 24 Participants | 7 Participants | 3 Participants | 34 Participants |
| Race/Ethnicity, Customized Race Black | 9 Participants | 9 Participants | 1 Participants | 19 Participants |
| Race/Ethnicity, Customized Race East/south east asian | 8 Participants | 7 Participants | 1 Participants | 16 Participants |
| Race/Ethnicity, Customized Race Japanese | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 13 Participants | 11 Participants | 1 Participants | 25 Participants |
| Race/Ethnicity, Customized Race South asian | 3 Participants | 2 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Race White/caucasian | 2430 Participants | 2446 Participants | 818 Participants | 5694 Participants |
| Sex: Female, Male Female | 1154 Participants | 1223 Participants | 401 Participants | 2778 Participants |
| Sex: Female, Male Male | 1335 Participants | 1264 Participants | 426 Participants | 3025 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 2,489 | 1 / 2,487 | 0 / 827 |
| other Total, other adverse events | 666 / 2,489 | 641 / 2,487 | 204 / 827 |
| serious Total, serious adverse events | 649 / 2,489 | 681 / 2,487 | 208 / 827 |
Outcome results
Primary
Phase A: Number of Subjects With Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition \[an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause\] at least in the opinion of the investigator and was confirmed by laboratory test \[Polymerase Chain Reaction (PCR) (+)\] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked \[Epi (+)\] to a valid index case.
Time frame: From 42 days post dose 2 until the end of Phase A
Population: The analysis was performed on the According-to-Protocol (ATP) Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Confirmed Varicella Case | 37 Participants |
| OKAH Group | Phase A: Number of Subjects With Confirmed Varicella Case | 243 Participants |
| MMR Group | Phase A: Number of Subjects With Confirmed Varicella Case | 201 Participants |
Comparison: Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.p-value: <0.000197.5% CI: [92.446, 96.615]Regression, Cox
Comparison: Vaccine Efficacy (VE) was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.p-value: 0.126597.5% CI: [57.182, 72.086]Regression, Cox
Secondary
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
Time frame: During Phase A (from Day 0 up to Year 2)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMRV Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 66.4 Hours | Standard Deviation 86 |
| MMRV Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 31.5 Hours | Standard Deviation 22.9 |
| MMRV Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 34.0 Hours | Standard Deviation 31.1 |
| OKAH Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 49.5 Hours | Standard Deviation 31.9 |
| OKAH Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 40.5 Hours | Standard Deviation 31.4 |
| OKAH Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 35.2 Hours | Standard Deviation 51.6 |
| MMR Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 48.1 Hours | Standard Deviation 35.3 |
| MMR Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 35.4 Hours | Standard Deviation 31.3 |
| MMR Group | Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 54.5 Hours | Standard Deviation 36.4 |
Secondary
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 1 | 4993.7 mIU/mL |
| MMRV Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 2 | 4709.6 mIU/mL |
| MMRV Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 42 | 3961.0 mIU/mL |
| MMRV Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 84 | 5809.6 mIU/mL |
| MMRV Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 0 | 75.7 mIU/mL |
| OKAH Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 84 | 3438.1 mIU/mL |
| OKAH Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 0 | 77.9 mIU/mL |
| OKAH Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 1 | 2856.8 mIU/mL |
| OKAH Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 2 | 2624.5 mIU/mL |
| OKAH Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 42 | 2602.7 mIU/mL |
| MMR Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 2 | 2677.9 mIU/mL |
| MMR Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 42 | 2817.4 mIU/mL |
| MMR Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 84 | 3695.0 mIU/mL |
| MMR Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Year 1 | 2885.7 mIU/mL |
| MMR Group | Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects | Anti-measles, Day 0 | 77.9 mIU/mL |
Secondary
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 1 | 1008.6 U/mL |
| MMRV Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 2 | 1050.6 U/mL |
| MMRV Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 42 | 896.6 U/mL |
| MMRV Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 84 | 1496.8 U/mL |
| MMRV Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 0 | 117.5 U/mL |
| OKAH Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 42 | 925.0 U/mL |
| OKAH Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 1 | 875.9 U/mL |
| OKAH Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 0 | 119.1 U/mL |
| OKAH Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 2 | 882.0 U/mL |
| OKAH Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 84 | 759.8 U/mL |
| MMR Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 2 | 989.4 U/mL |
| MMR Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 0 | 118.1 U/mL |
| MMR Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 42 | 945.2 U/mL |
| MMR Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Day 84 | 1547.9 U/mL |
| MMR Group | Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects | Anti-mumps, Year 1 | 1089.6 U/mL |
Secondary
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 1 | 88.7 IU/mL |
| MMRV Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 84 | 104.7 IU/mL |
| MMRV Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 42 | 57.6 IU/mL |
| MMRV Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 0 | 2.1 IU/mL |
| MMRV Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 2 | 71.8 IU/mL |
| OKAH Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 84 | 122.1 IU/mL |
| OKAH Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 42 | 74.0 IU/mL |
| OKAH Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 0 | 2.0 IU/mL |
| OKAH Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 1 | 103.7 IU/mL |
| OKAH Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 2 | 79.1 IU/mL |
| MMR Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 2 | 71.8 IU/mL |
| MMR Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Year 1 | 98.0 IU/mL |
| MMR Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 0 | 2.1 IU/mL |
| MMR Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 84 | 111.9 IU/mL |
| MMR Group | Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects | Anti-rubella, Day 42 | 71.0 IU/mL |
Secondary
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 0 | 12.8 mIU/mL |
| MMRV Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 1 | 365.1 mIU/mL |
| MMRV Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 84 | 1833.3 mIU/mL |
| MMRV Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 2 | 414.6 mIU/mL |
| MMRV Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 42 | 116.1 mIU/mL |
| OKAH Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 2 | 170.6 mIU/mL |
| OKAH Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 0 | 12.7 mIU/mL |
| OKAH Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 42 | 13.5 mIU/mL |
| OKAH Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 84 | 98.1 mIU/mL |
| OKAH Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 1 | 145.2 mIU/mL |
| MMR Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 42 | 13.1 mIU/mL |
| MMR Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 2 | 36.9 mIU/mL |
| MMR Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 1 | 20.3 mIU/mL |
| MMR Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 0 | 12.6 mIU/mL |
| MMR Group | Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Day 84 | 14.7 mIU/mL |
Secondary
Phase A: Number of Subjects Reporting Fever
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 332 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 78 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 249 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 112 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 136 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 139 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 332 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 49 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 359 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 136 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 203 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 136 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 303 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 222 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 212 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 141 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 303 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 71 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 503 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 9 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 22 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 20 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 25 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 503 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 66 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 51 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 48 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 439 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 147 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 90 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 240 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 240 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 18 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 439 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 297 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 191 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 100 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 43 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 177 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 313 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 144 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 144 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 88 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 54 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 32 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 9 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 313 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 205 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 132 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 74 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 25 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 119 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 132 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 20 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 5 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 82 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 11 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 13 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 30 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 3 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 29 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 29 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 103 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 46 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 44 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 46 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 69 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 103 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 15 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 82 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 41 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 55 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 8 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 41 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 84 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 54 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 25 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 132 Participants |
Secondary
Phase A: Number of Subjects Reporting Fever
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Time frame: Within 15 days (Day 0-14) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 19 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 67 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 450 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 328 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 328 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 216 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 135 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 449 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 300 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 196 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 101 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 30 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 140 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 189 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 118 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 118 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 60 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 34 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 17 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 6 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 184 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 101 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 62 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 28 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 8 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 43 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 213 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 200 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 124 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 58 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 11 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 21 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 110 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 100 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 201 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 125 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 65 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 125 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 73 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 41 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 42 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 35 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 354 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 22 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 226 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 226 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 134 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 5 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 82 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 15 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 349 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 48 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 1 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 2 | 16 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 1 | 36 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 1 | 34 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 2 | 51 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 40°C, Dose 2 | 3 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 1 | 16 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 1 | 54 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 1 | 102 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 1 | 6 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 1 | 10 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39°C, Dose 1 | 23 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 1 | 26 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 38.5°C, Dose 2 | 30 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 1 | 69 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | All Fever, Dose 2 | 55 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 40°C, Dose 2 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 39.5°C, Dose 2 | 9 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever, Dose 2 | 32 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever ≥ 38°C, Dose 1 | 101 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 1 | 69 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever ≥ 38°C, Dose 2 | 32 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39°C, Dose 2 | 24 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever > 39.5°C, Dose 2 | 14 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Related Fever > 38.5°C, Dose 2 | 18 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Fever | Fever Medical Advice, Dose 2 | 13 Participants |
Secondary
Phase A: Number of Subjects Reporting Meningism
Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 1 | 1 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 1 | 1 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 1 | 1 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 1 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 2 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 1 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Related Meningism, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Any Meningism, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Meningism | Grade 3 Meningism, Dose 2 | 0 Participants |
Secondary
Phase A: Number of Subjects Reporting Parotitis
Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 1 | 4 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 1 | 2 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 1 | 3 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 2 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 1 | 5 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 2 | 2 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 2 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 1 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 1 | 3 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Related Parotitis, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Any Parotitis, Dose 1 | 1 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Parotitis | Grade 3 Parotitis, Dose 2 | 0 Participants |
Secondary
Phase A: Number of Subjects Reporting Rash
Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = \> 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 1 | 41 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 1 | 82 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 2 | 5 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 1 | 30 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 2 | 8 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 2 | 42 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 1 | 9 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 2 | 37 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 1 | 27 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 1 | 2 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 2 | 5 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 1 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 2 | 12 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 2 | 9 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 1 | 14 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 2 | 2 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 2 | 5 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 1 | 68 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 1 | 14 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 2 | 6 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 2 | 4 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 2 | 24 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 1 | 84 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 1 | 15 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 1 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 1 | 14 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 1 | 69 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 1 | 41 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 1 | 24 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 1 | 12 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 1 | 2 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 1 | 32 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 2 | 36 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 2 | 12 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 2 | 2 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 2 | 10 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 2 | 11 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 2 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 2 | 6 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 1 | 30 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 2 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 1 | 24 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 2 | 1 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 1 | 6 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Localized Other site, Dose 2 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Localized Admin. site, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 2 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Localized, Dose 1 | 6 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 4, Dose 1 | 4 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 1 | 7 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Generalized, Dose 2 | 5 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Related, Dose 1 | 13 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Measles/Rubella, Dose 1 | 9 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized Grade 3/4, Dose 2 | 1 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Any Localized or Generalized,Dose 2 | 9 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Rash | Generalized With fever, Dose 1 | 14 Participants |
Secondary
Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time frame: From Day 0 until the end of Phase A (Year 2)
Population: The analysis was performed on the Total Vaccinated cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs) | 473 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs) | 480 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs) | 148 Participants |
Secondary
Phase A: Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (\>) 20 mm.
Time frame: 4 days post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 1 | 74 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 1 | 137 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 3 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 1 | 38 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 3 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 2 | 91 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 2 | 188 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 26 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 2 | 72 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 4 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 1 | 83 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 2 | 63 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 2 | 106 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 2 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 2 | 31 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 1 | 154 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 1 | 37 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 3 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 3 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Redness, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 2 | 16 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Swelling, Dose 2 | 3 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Pain, Dose 1 | 20 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 2 | 23 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Any Redness, Dose 1 | 36 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
Secondary
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE assessed included any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 1 | 301 Participants |
| MMRV Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 2 | 239 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 1 | 303 Participants |
| OKAH Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 2 | 258 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 1 | 82 Participants |
| MMR Group | Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs) | Any AE(s), Dose 2 | 90 Participants |
Secondary
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration \< 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 84 | 704 Participants |
| MMRV Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 0 | 7 Participants |
| MMRV Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 42 | 688 Participants |
| MMRV Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 1 | 630 Participants |
| MMRV Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 2 | 589 Participants |
| OKAH Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 0 | 5 Participants |
| OKAH Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 42 | 693 Participants |
| OKAH Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 84 | 710 Participants |
| OKAH Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 1 | 628 Participants |
| OKAH Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 2 | 590 Participants |
| MMR Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 84 | 231 Participants |
| MMR Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 0 | 2 Participants |
| MMR Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 1 | 200 Participants |
| MMR Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Year 2 | 186 Participants |
| MMR Group | Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects | Anti-rubella, Day 42 | 230 Participants |
Secondary
Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster
The number of subjects with confirmed cases of herpes zoster is reported.
Time frame: From Day 0 until the end of Phase A (Year 2)
Population: The analysis was performed on the Total Vaccinated Cohort, which included all vaccinated subjects.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster | 0 Participants |
| OKAH Group | Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster | 0 Participants |
| MMR Group | Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster | 0 Participants |
Secondary
Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Time frame: From 42 days post dose 2 until the end of Phase A
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 2 Participants |
| OKAH Group | Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 37 Participants |
| MMR Group | Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 117 Participants |
Comparison: VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.p-value: 0.000195% CI: [97.522, 99.898]Regression, Cox
Comparison: VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.p-value: 0.126595% CI: [85.866, 93.934]Regression, Cox
Secondary
Phase A: Number of Subjects With Probable or Confirmed Varicella Case
Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case.
Time frame: From 42 days post dose 2 until the end of Phase A
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Probable or Confirmed Varicella Case | 57 Participants |
| OKAH Group | Phase A: Number of Subjects With Probable or Confirmed Varicella Case | 260 Participants |
| MMR Group | Phase A: Number of Subjects With Probable or Confirmed Varicella Case | 209 Participants |
Comparison: VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.p-value: <0.000195% CI: [89.927, 94.396]Regression, Cox
Comparison: VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.p-value: 0.126595% CI: [57.503, 70.486]Regression, Cox
Secondary
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration \< 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 1 | 628 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 0 | 2 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 42 | 676 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 84 | 703 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 2 | 584 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 42 | 682 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 2 | 583 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 84 | 702 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 1 | 621 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 0 | 7 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 0 | 2 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 42 | 225 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 1 | 198 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Year 2 | 183 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects | Anti-measles, Day 84 | 230 Participants |
Secondary
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration \< 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 1 | 569 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 84 | 683 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 0 | 4 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 42 | 584 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 2 | 527 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 84 | 608 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 0 | 6 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 42 | 613 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 1 | 554 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 2 | 520 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 2 | 171 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Year 1 | 182 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 0 | 2 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 84 | 225 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects | Anti-mumps, Day 42 | 208 Participants |
Secondary
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV
Seronegative (S-) = Subjects with antibody concentration less than (\<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time frame: At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Population: The analysis was performed on the ATP Cohort for Immunogenicity, which included all evaluable subjects who had pre-vaccination results available for at least one of the vaccine components.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 1 | 2056 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 0 | 26 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 2 | 1913 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 84 | 2236 Participants |
| MMRV Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 42 | 661 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 1 | 1968 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 42 | 21 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 0 | 24 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 2 | 1776 Participants |
| OKAH Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 84 | 2123 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 2 | 170 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 84 | 40 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 0 | 4 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Day 42 | 6 Participants |
| MMR Group | Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV | Anti-VZV, Year 1 | 91 Participants |
Secondary
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions
Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.
Time frame: Within 43 days (Day 0-42) post-vaccination period following each dose
Population: The analysis was performed on a subset of the Total Vaccinated Cohort. The subset of subjects was identified as 200 subjects from each country. Depending on the country, this subset was stipulated to be either the first 200 subjects enrolled irrespective of the study center or 200 subjects enrolled at selected centers.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 1 | 1 Participants |
| MMRV Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 2 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 1 | 0 Participants |
| OKAH Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 2 | 1 Participants |
| MMR Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 2 | 0 Participants |
| MMR Group | Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions | Meningism including febrile convulsions, Dose 1 | 0 Participants |
Secondary
Phase B: Characteristics of Varicella Cases
Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Time frame: From the beginning of Phase B (Year 2) up to study end (Year 10)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed or Probable | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Encephalitis | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 0 days | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 2 | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Interstitial pneumonia | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 1-5 days | 23 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 1 | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Pain in back or abdomen | 6 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 6-10 days | 10 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, No case | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Fever, 40+ °C | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 11-15 days | 5 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Mild | 34 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Fever, 38.8°C to 39.9°C | 1 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 16+ days | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Treatment, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Fever, No fever | 37 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Duration of rash, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 1-50 | 32 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 1-50 | 32 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 501+ | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 51-100 | 5 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Treatment, No | 23 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 101-500 | 1 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Treatment, Yes | 15 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 51-100 | 5 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Severe | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Complications, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 101-500 | 1 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Outcome, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Complications, No | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 501+ | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed PCR | 31 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Complications, Yes | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Moderately severe | 4 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Missing | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Macular | 4 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved with sequelae | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Severely ill | 0 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Papular | 16 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed EPI | 7 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Moderately ill | 10 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Vesicular | 16 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Varicella type, Any | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Haemorragic | 2 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved | 38 Participants |
| MMRV Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Does not appear ill | 28 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Treatment, Missing | 4 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 1 | 223 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 2 | 2 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, Any | 225 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed | 225 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed PCR | 207 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed EPI | 18 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed or Probable | 225 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Varicella type, No case | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 1-50 | 173 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 51-100 | 35 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 101-500 | 15 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 501+ | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, Missing | 2 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Macular | 6 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Papular | 108 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Vesicular | 100 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Haemorragic | 6 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Missing | 5 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 0 days | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 1-5 days | 140 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 6-10 days | 67 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 11-15 days | 13 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 16+ days | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Duration of rash, Missing | 5 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 1-50 | 173 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 51-100 | 35 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 101-500 | 15 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 501+ | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], Missing | 2 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Fever, No fever | 212 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Fever, 38.8°C to 39.9°C | 13 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Fever, 40+ °C | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Pain in back or abdomen | 27 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Interstitial pneumonia | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Encephalitis | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Does not appear ill | 159 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Moderately ill | 64 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Severely ill | 1 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Missing | 1 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Complications, Yes | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Complications, No | 222 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Complications, Missing | 3 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Treatment, Yes | 115 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Treatment, No | 106 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved | 224 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved with sequelae | 0 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Outcome, Missing | 1 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Mild | 198 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Moderately severe | 27 Participants |
| OKAH Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Severe | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Missing | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved | 148 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Encephalitis | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Haemorragic | 4 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed PCR | 140 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Does not appear ill | 62 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Papular | 63 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Severe | 4 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Moderately ill | 80 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Macular | 1 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Outcome, Recovered/resolved with sequelae | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Severely ill | 6 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, Missing | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed | 149 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Assessment by investigator, Missing | 1 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 501+ | 7 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Moderately severe | 54 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Complications, Yes | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 101-500 | 27 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Outcome, Missing | 1 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Complications, No | 147 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 51-100 | 39 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, Any | 149 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Complications, Missing | 2 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Character of most lesions, Vesicular | 81 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 1 | 148 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Treatment, Yes | 91 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 51-100 | 39 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Rash: number of lesions, 1-50 | 76 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 101-500 | 27 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 1-50 | 76 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Intensity of severity, Mild | 91 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], 501+ | 7 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, Missing | 1 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Treatment, No | 56 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Max. number of lesions [investigator], Missing | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 16+ days | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, No case | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Fever, No fever | 100 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 11-15 days | 19 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed or Probable | 149 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Fever, 38.8°C to 39.9°C | 43 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 6-10 days | 61 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Treatment, Missing | 2 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Fever, 40+ °C | 6 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 1-5 days | 68 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Varicella type, Confirmed EPI | 9 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Pain in back or abdomen | 27 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Duration of rash, 0 days | 0 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Number of varicella cases by subject, 2 | 1 Participants |
| MMR Group | Phase B: Characteristics of Varicella Cases | Systemic sign, Interstitial pneumonia | 0 Participants |
Secondary
Phase B: Characteristics of Zoster Cases
Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Time frame: From 6 weeks after Dose 2 until study end (Year 10)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase A), which included all evaluable subjects who had efficacy follow-up starting from 42 days post dose 2 and from the period when Phase A was completed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 101-500 | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 501+ | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Haemorrhagic | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Fever, 38.8°C to 39.9°C | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 1-50 | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Fever, 40+ °C | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 0 days | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Pain in back or abdomen | 2 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 501+ | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Interstitial pneumonia | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 1-5 days | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Encephalitis | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Complications, Yes | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Does not appear ill | 3 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 6-10 days | 1 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Moderately ill | 1 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Macular | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Severely ill | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 11-15 days | 3 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Complications, No | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 51-100 | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Treatment, Yes | 2 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 16+ days | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Treatment, No | 2 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Papular | 2 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Outcome, Recovered/resolved | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 1-50 | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Outcome, Recovered/resolved with sequelae | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Fever, No fever | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Mild | 4 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 51-100 | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Moderately severe | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Vesicular | 2 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Severe | 0 Participants |
| MMRV Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 101-500 | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Severe | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Complications, Yes | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 1-50 | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 51-100 | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 101-500 | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Rash: number of lesions, 501+ | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Macular | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Papular | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Vesicular | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Character of most lesions, Haemorrhagic | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 0 days | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 1-5 days | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 6-10 days | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 11-15 days | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Duration of rash, 16+ days | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 1-50 | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 51-100 | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 101-500 | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Fever, No fever | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Fever, 38.8°C to 39.9°C | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Fever, 40+ °C | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Pain in back or abdomen | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Interstitial pneumonia | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Systemic signs, Encephalitis | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Does not appear ill | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Moderately ill | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Assessment by investigator, Severely ill | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Complications, No | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Treatment, Yes | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Treatment, No | 1 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Outcome, Recovered/resolved | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Outcome, Recovered/resolved with sequelae | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Mild | 2 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Intensity of severity, Moderately severe | 0 Participants |
| OKAH Group | Phase B: Characteristics of Zoster Cases | Max. number of lesions [investigator], 501+ | 0 Participants |
Secondary
Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
Time frame: During Phase B
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| MMRV Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 40.7 Hours | Standard Deviation 35.6 |
| MMRV Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 42.8 Hours | Standard Deviation 44.1 |
| MMRV Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 0 Hours | Standard Deviation 0 |
| OKAH Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 48.0 Hours | Standard Deviation 34.1 |
| OKAH Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 44.6 Hours | Standard Deviation 31.1 |
| OKAH Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 45.7 Hours | Standard Deviation 21.5 |
| MMR Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost from work [hours] | 57.8 Hours | Standard Deviation 36.8 |
| MMR Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time of requested assistance [hours] | 49.4 Hours | Standard Deviation 50 |
| MMR Group | Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness | Time lost for subjects [hours] | 57.2 Hours | Standard Deviation 36.1 |
Secondary
Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 4 | 3290.9 mIU/mL |
| MMRV Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 6 | 2795.9 mIU/mL |
| MMRV Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 8 | 2342.0 mIU/mL |
| MMRV Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 10 | 1857.2 mIU/mL |
| OKAH Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 10 | 997.5 mIU/mL |
| OKAH Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 4 | 1803.5 mIU/mL |
| OKAH Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 8 | 1575.1 mIU/mL |
| OKAH Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 6 | 1727.7 mIU/mL |
| MMR Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 10 | 913.6 mIU/mL |
| MMR Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 6 | 1369.0 mIU/mL |
| MMR Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 8 | 1175.5 mIU/mL |
| MMR Group | Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations | Anti-measles, Year 4 | 1724.4 mIU/mL |
Secondary
Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 4 | 1088.9 U/mL |
| MMRV Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 6 | 999.7 U/mL |
| MMRV Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 8 | 875.7 U/mL |
| MMRV Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 10 | 889.3 U/mL |
| OKAH Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 10 | 1054.0 U/mL |
| OKAH Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 4 | 905.3 U/mL |
| OKAH Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 8 | 865.7 U/mL |
| OKAH Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 6 | 920.5 U/mL |
| MMR Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 10 | 912.7 U/mL |
| MMR Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 6 | 1030.3 U/mL |
| MMR Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 8 | 869.1 U/mL |
| MMR Group | Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations | Anti-mumps, Year 4 | 1059.1 U/mL |
Secondary
Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 4 | 44.4 IU/mL |
| MMRV Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 6 | 30.1 IU/mL |
| MMRV Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 8 | 20.8 IU/mL |
| MMRV Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 10 | 18.8 IU/mL |
| OKAH Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 10 | 29.2 IU/mL |
| OKAH Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 4 | 50.8 IU/mL |
| OKAH Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 8 | 26.7 IU/mL |
| OKAH Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 6 | 34.0 IU/mL |
| MMR Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 10 | 20.8 IU/mL |
| MMR Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 6 | 33.3 IU/mL |
| MMR Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 8 | 23.3 IU/mL |
| MMR Group | Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations | Anti-rubella, Year 4 | 49.0 IU/mL |
Secondary
Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| MMRV Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 4 | 501.3 mIU/mL |
| MMRV Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 6 | 680.6 mIU/mL |
| MMRV Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 8 | 512.5 mIU/mL |
| MMRV Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 10 | 471.3 mIU/mL |
| OKAH Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 10 | 404.6 mIU/mL |
| OKAH Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 4 | 272.7 mIU/mL |
| OKAH Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 8 | 418.5 mIU/mL |
| OKAH Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 6 | 417.6 mIU/mL |
| MMR Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 10 | 219.6 mIU/mL |
| MMR Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 6 | 91.8 mIU/mL |
| MMR Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 8 | 146.9 mIU/mL |
| MMR Group | Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations | Anti-VZV, Year 4 | 32.4 mIU/mL |
Secondary
Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time frame: From the beginning of Phase B (Year 2) up to study end (Year 10)
Population: The analysis was performed on the Total enrolled cohort in Phase B, which included all subjects from the Total Vaccinated cohort in Phase A who returned for at least one visit in Phase B
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs) | 290 Participants |
| OKAH Group | Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs) | 317 Participants |
| MMR Group | Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs) | 93 Participants |
Secondary
Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value
The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 4 | 407 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 6 | 402 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 8 | 353 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 10 | 339 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 10 | 39 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 4 | 402 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 8 | 121 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 6 | 218 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 10 | 109 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 6 | 128 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 8 | 113 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value | Anti-measles, Year 4 | 131 Participants |
Secondary
Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value
The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 6 | 360 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 10 | 305 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 4 | 368 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 8 | 305 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 8 | 107 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 4 | 357 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 10 | 36 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 6 | 196 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 10 | 108 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 6 | 127 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 4 | 123 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value | Anti-mumps, Year 8 | 108 Participants |
Secondary
Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value
The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort, subset for MMR testing (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 4 | 407 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 6 | 402 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 8 | 347 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 10 | 334 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 10 | 39 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 4 | 408 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 8 | 120 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 6 | 222 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 10 | 112 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 6 | 136 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 8 | 116 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value | Anti-rubella, Year 4 | 137 Participants |
Secondary
Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value
The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.
Time frame: At Year 4, Year 6, Year 8 and Year 10 time points
Population: The analysis was performed on the Adapted persistence cohort (Adapted ATP cohort for each specific time point).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 4 | 1330 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 6 | 1289 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 8 | 1142 Participants |
| MMRV Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 10 | 1164 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 10 | 818 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 4 | 1061 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 8 | 806 Participants |
| OKAH Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 6 | 986 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 10 | 81 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 6 | 97 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 8 | 78 Participants |
| MMR Group | Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value | Anti-VZV, Year 4 | 73 Participants |
Secondary
Phase B: Number of Subjects With Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case.
Time frame: From the beginning of Phase B (Year 2) up to study end (Year 10)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Confirmed Varicella Case | 38 Participants |
| OKAH Group | Phase B: Number of Subjects With Confirmed Varicella Case | 225 Participants |
| MMR Group | Phase B: Number of Subjects With Confirmed Varicella Case | 149 Participants |
Comparison: VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.p-value: <0.000195% CI: [94.075, 97.101]Regression, Cox
Comparison: VE was measured by calculating the relative risk of a confirmed varicella case in a vaccine group compared to a confirmed varicella case in the control group.p-value: 0.126595% CI: [62.848, 75.47]Regression, Cox
Secondary
Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test \[PCR (+)\] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked \[Epi (+)\] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Time frame: From the beginning of Phase B (Year 2) up to study end (Year 10)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 6 Participants |
| OKAH Group | Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 67 Participants |
| MMR Group | Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 176 Participants |
Comparison: VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.p-value: <0.000195% CI: [97.907, 99.589]Regression, Cox
Comparison: VE was measured by calculating the relative risk of a moderate or severe confirmed varicella case in a vaccine group compared to a moderate or severe confirmed varicella case in the control group.p-value: 0.126595% CI: [86.126, 92.102]Regression, Cox
Secondary
Phase B: Number of Subjects With Probable or Confirmed Varicella Case
Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed \[PCR (-)\] AND was not epidemiologically linked \[Epi (-)\] to another probable or confirmed case.
Time frame: From the beginning of Phase B (Year 2) up to study end (Year 10)
Population: The analysis was performed on the ATP Cohort for Efficacy (Phase B), which included all evaluable subjects who had efficacy follow-up from the period when Phase A was completed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MMRV Group | Phase B: Number of Subjects With Probable or Confirmed Varicella Case | 49 Participants |
| OKAH Group | Phase B: Number of Subjects With Probable or Confirmed Varicella Case | 237 Participants |
| MMR Group | Phase B: Number of Subjects With Probable or Confirmed Varicella Case | 152 Participants |
Comparison: VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.p-value: <0.000195% CI: [92.838, 96.248]Regression, Cox
Comparison: VE was measured by calculating the relative risk of a probable or confirmed varicella case in a vaccine group compared to a probable or confirmed varicella case in the control group.p-value: 0.126595% CI: [61.893, 74.671]Regression, Cox