A Phase 3 interventional study of Priorix-tetra™ and Priorix™ in Varicella and Chickenpox Vaccines, sponsored by GlaxoSmithKline. Completed at 104 sites in 10 countries. Open to participants aged 11 Months to 22 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-23.
Sponsored by GlaxoSmithKline · Phase 3, Interventional, and Prevention
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Among 36 studies testing Chickenpox Vaccine in Chickenpox — 5 open to participants now, 7 under way, 4 of them phase 3. Chickenpox Vaccine · Chickenpox.
Among the 36 studies testing Chickenpox Vaccine in Chickenpox, this one is the 6th largest by enrollment, is one of 3 that started in 2005, is one of 12 in phase 3, and was the 3rd registered.
180 studies on the registry are indexed under Chickenpox; 28 are open to participants now.
Browse Chickenpox studies →5 of the 36 studies testing Chickenpox Vaccine in Chickenpox are open now, in 7 countries. Recruiting first, the newest first:
SK Bioscience Co., Ltd. · Sites in Honduras, Philippines, Korea, Republic of and 1 more country
Ages 12 mo–12 yrs · Healthy volunteers
University Hospital, Geneva · Sites in Switzerland
Ages up to 18
Sinovac (Dalian) Vaccine Technology Co., Ltd. · Sites in China
Ages 8–16 · Healthy volunteers
Sinovac (Dalian) Vaccine Technology Co., Ltd. · Sites in China
Ages 1–17 · Healthy volunteers
Sinovac (Dalian) Vaccine Technology Co., Ltd. · Sites in Vietnam
Ages 1–12 · Healthy volunteers
By country, each count listing its studies:
Chickenpox Vaccine: first FDA approval 1995 (Varivax). What it is approved for, and how studies give it, is on its page →
Of the 16 Chickenpox studies recruiting now, 3 (19%) set no upper age limit and 13 (81%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 11 Months to 22 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
36 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 6 · Phase 2 6 · Phase 3 14 · Phase 4 14
First in 1998; this study’s year is marked. 3 started in 2005.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 5,803 is above the median of 475 across 149 interventional studies indexed under Chickenpox.
Median enrollment 404 across the 36 interventional studies. Of the 20 that completed or were terminated, 5 (25%) have results posted.
This tab as a report to print or save as PDF → With an account.
21 of 36 have an industry lead sponsor. The 10 most frequent:
GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
35 studies in Chickenpox by GlaxoSmithKline: 6 open now, 6 under way, 6 of them phase 3. Of 28 finished, 16 (57%) have results posted.
Among the 35 studies in Chickenpox by GlaxoSmithKline, this one has the largest enrollment of the 29 interventional ones that give a count, is one of 6 that started in 2005, is one of 18 in phase 3, and was the 7th registered.
GlaxoSmithKline’s Chickenpox studies by the year they started, since 2003.
1 of the studies testing Chickenpox Vaccine in Chickenpox that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07415252Phase 3SK Bioscience Co., Ltd.SkyVaricella® (NBP608) Vaccine With Lower Potencies in Healthy Children Aged 12 Months to 12 Years | 2027-02-13 |
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Among the 36 studies testing Chickenpox Vaccine in Chickenpox, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among GlaxoSmithKline’s 35 in Chickenpox:
Nothing recorded among them since 2026-09-25.
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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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects:
Exclusion criteria:
Additional exclusion criteria for subjects included in the subset:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Biological: Priorix-tetra™
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.
Biological: Priorix™ · Biological: Varilrix™
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).
Biological: Priorix™
2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group
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
1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
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
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
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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
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
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
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
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)
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)
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)
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)
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)
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)
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
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
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
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
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
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
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
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
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)
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)
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
| Milestone | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Started | 2489 | 2487 | 827 |
| Completed | 1415 | 1415 | 468 |
| Not completed | 1074 | 1072 | 359 |
| Withdrew: Adverse event | 10 | 6 | 3 |
| Withdrew: Others | 1064 | 1066 | 356 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase A: Number of Subjects With Confirmed Varicella Case | 37 | 243 | 201 |
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).
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 2 | 37 | 117 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase A: Number of Subjects With Probable or Confirmed Varicella Case | 57 | 260 | 209 |
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
| mIU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-VZV, Day 0 | 12.8 (12.6 to 12.9) | 12.7 (12.6 to 12.8) | 12.6 (12.5 to 12.8) |
| Anti-VZV, Day 42 | 116.1 (108.3 to 124.5) | 13.5 (13.0 to 14.1) | 13.1 (12.5 to 13.9) |
| Anti-VZV, Day 84 | 1833.3 (1767.8 to 1901.3) | 98.1 (94.2 to 102.3) | 14.7 (13.9 to 15.6) |
| Anti-VZV, Year 1 | 365.1 (349.0 to 381.9) | 145.2 (137.0 to 153.8) | 20.3 (18.2 to 22.5) |
| Anti-VZV, Year 2 | 414.6 (392.1 to 438.5) | 170.6 (158.1 to 184.1) | 36.9 (31.6 to 43.1) |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-VZV, Day 0 | 26 | 24 | 4 |
| Anti-VZV, Day 42 | 661 | 21 | 6 |
| Anti-VZV, Day 84 | 2236 | 2123 | 40 |
| Anti-VZV, Year 1 | 2056 | 1968 | 91 |
| Anti-VZV, Year 2 | 1913 | 1776 | 170 |
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
| mIU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-measles, Day 0 | 75.7 (74.6 to 76.8) | 77.9 (75.6 to 80.3) | 77.9 (73.9 to 82.1) |
| Anti-measles, Day 42 | 3961.0 (3719.7 to 4217.9) | 2602.7 (2429.6 to 2788.1) | 2817.4 (2506.3 to 3167.1) |
| Anti-measles, Day 84 | 5809.6 (5544.5 to 6087.3) | 3438.1 (3210.9 to 3681.5) | 3695.0 (3318.2 to 4114.6) |
| Anti-measles, Year 1 | 4993.7 (4714.7 to 5289.2) | 2856.8 (2658.6 to 3069.7) | 2885.7 (2520.7 to 3303.5) |
| Anti-measles, Year 2 | 4709.6 (4407.1 to 5033.0) | 2624.5 (2423.6 to 2842.2) | 2677.9 (2302.5 to 3114.5) |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-measles, Day 0 | 2 | 7 | 2 |
| Anti-measles, Day 42 | 676 | 682 | 225 |
| Anti-measles, Day 84 | 703 | 702 | 230 |
| Anti-measles, Year 1 | 628 | 621 | 198 |
| Anti-measles, Year 2 | 584 | 583 | 183 |
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
| U/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-mumps, Day 0 | 117.5 (115.4 to 119.7) | 119.1 (116.2 to 122.2) | 118.1 (114.4 to 122.0) |
| Anti-mumps, Day 42 | 896.6 (827.0 to 972.0) | 925.0 (859.4 to 995.7) | 945.2 (839.0 to 1064.9) |
| Anti-mumps, Day 84 | 1496.8 (1407.7 to 1591.7) | 759.8 (705.5 to 818.3) | 1547.9 (1408.0 to 1701.6) |
| Anti-mumps, Year 1 | 1008.6 (928.8 to 1095.2) | 875.9 (805.8 to 952.2) | 1089.6 (944.0 to 1257.5) |
| Anti-mumps, Year 2 | 1050.6 (957.5 to 1152.7) | 882.0 (805.6 to 965.6) | 989.4 (848.3 to 1153.9) |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-mumps, Day 0 | 4 | 6 | 2 |
| Anti-mumps, Day 42 | 584 | 613 | 208 |
| Anti-mumps, Day 84 | 683 | 608 | 225 |
| Anti-mumps, Year 1 | 569 | 554 | 182 |
| Anti-mumps, Year 2 | 527 | 520 | 171 |
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
| IU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-rubella, Day 0 | 2.1 (2.0 to 2.1) | 2.0 (2.0 to 2.1) | 2.1 (2.0 to 2.2) |
| Anti-rubella, Day 42 | 57.6 (54.2 to 61.2) | 74.0 (69.9 to 78.3) | 71.0 (64.8 to 77.8) |
| Anti-rubella, Day 84 | 104.7 (99.8 to 109.8) | 122.1 (116.2 to 128.2) | 111.9 (103.5 to 120.9) |
| Anti-rubella, Year 1 | 88.7 (83.9 to 93.8) | 103.7 (97.8 to 110.0) | 98.0 (88.7 to 108.3) |
| Anti-rubella, Year 2 | 71.8 (67.5 to 76.4) | 79.1 (74.2 to 84.3) | 71.8 (64.0 to 80.5) |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-rubella, Day 0 | 7 | 5 | 2 |
| Anti-rubella, Day 42 | 688 | 693 | 230 |
| Anti-rubella, Day 84 | 704 | 710 | 231 |
| Anti-rubella, Year 1 | 630 | 628 | 200 |
| Anti-rubella, Year 2 | 589 | 590 | 186 |
The number of subjects with confirmed cases of herpes zoster is reported.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster | 0 | 0 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| All Fever, Dose 1 | 503 | 439 | 132 |
| Related Fever, Dose 1 | 332 | 240 | 82 |
| Related Fever ≥ 38°C, Dose 1 | 332 | 240 | 82 |
| Related Fever > 38.5°C, Dose 1 | 222 | 147 | 46 |
| Related Fever > 39°C, Dose 1 | 141 | 90 | 29 |
| Related Fever > 39.5°C, Dose 1 | 71 | 48 | 13 |
| Related Fever > 40°C, Dose 1 | 22 | 18 | 5 |
| Fever ≥ 38°C, Dose 1 | 503 | 439 | 132 |
| Fever > 38.5°C, Dose 1 | 359 | 297 | 84 |
| Fever > 39°C, Dose 1 | 249 | 191 | 55 |
| Fever > 39.5°C, Dose 1 | 139 | 100 | 29 |
| Fever > 40°C, Dose 1 | 49 | 43 | 15 |
| Fever Medical Advice, Dose 1 | 203 | 177 | 46 |
| All Fever, Dose 2 | 303 | 313 | 103 |
| Related Fever, Dose 2 | 136 | 144 | 41 |
| Related Fever ≥ 38°C, Dose 2 | 136 | 144 | 41 |
| Related Fever > 38.5°C, Dose 2 | 78 | 88 | 25 |
| Related Fever > 39°C, Dose 2 | 51 | 54 | 20 |
| Related Fever > 39.5°C, Dose 2 | 25 | 32 | 11 |
| Related Fever > 40°C, Dose 2 | 9 | 9 | 3 |
| Fever ≥ 38°C, Dose 2 | 303 | 313 | 103 |
| Fever > 38.5°C, Dose 2 | 212 | 205 | 69 |
| Fever > 39°C, Dose 2 | 136 | 132 | 54 |
| Fever > 39.5°C, Dose 2 | 66 | 74 | 30 |
| Fever > 40°C, Dose 2 | 20 | 25 | 8 |
| Fever Medical Advice, Dose 2 | 112 | 119 | 44 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| All Fever, Dose 1 | 450 | 354 | 102 |
| Related Fever, Dose 1 | 328 | 226 | 69 |
| Related Fever ≥ 38°C, Dose 1 | 328 | 226 | 69 |
| Related Fever > 38.5°C, Dose 1 | 216 | 134 | 36 |
| Related Fever > 39°C, Dose 1 | 135 | 82 | 23 |
| Related Fever > 39.5°C, Dose 1 | 67 | 42 | 10 |
| Related Fever > 40°C, Dose 1 | 19 | 15 | 4 |
| Fever ≥ 38°C, Dose 1 | 449 | 349 | 101 |
| Fever > 38.5°C, Dose 1 | 300 | 213 | 54 |
| Fever > 39°C, Dose 1 | 196 | 124 | 34 |
| Fever > 39.5°C, Dose 1 | 101 | 58 | 16 |
| Fever > 40°C, Dose 1 | 30 | 21 | 6 |
| Fever Medical Advice, Dose 1 | 140 | 100 | 26 |
| All Fever, Dose 2 | 189 | 201 | 55 |
| Related Fever, Dose 2 | 118 | 125 | 32 |
| Related Fever ≥ 38°C, Dose 2 | 118 | 125 | 32 |
| Related Fever > 38.5°C, Dose 2 | 60 | 73 | 18 |
| Related Fever > 39°C, Dose 2 | 34 | 41 | 16 |
| Related Fever > 39.5°C, Dose 2 | 17 | 22 | 9 |
| Related Fever > 40°C, Dose 2 | 6 | 5 | 3 |
| Fever ≥ 38°C, Dose 2 | 184 | 200 | 51 |
| Fever > 38.5°C, Dose 2 | 101 | 110 | 30 |
| Fever > 39°C, Dose 2 | 62 | 65 | 24 |
| Fever > 39.5°C, Dose 2 | 28 | 35 | 14 |
| Fever > 40°C, Dose 2 | 8 | 11 | 4 |
| Fever Medical Advice, Dose 2 | 43 | 48 | 13 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Any Pain, Dose 1 | 74 | 83 | 20 |
| Grade 3 Pain, Dose 1 | 1 | 2 | 0 |
| Any Redness, Dose 1 | 137 | 154 | 36 |
| Grade 3 Redness, Dose 1 | 3 | 3 | 0 |
| Any Swelling, Dose 1 | 38 | 37 | 6 |
| Grade 3 Swelling, Dose 1 | 3 | 0 | 0 |
| Any Pain, Dose 2 | 91 | 63 | 16 |
| Grade 3 Pain, Dose 2 | 0 | 1 | 1 |
| Any Redness, Dose 2 | 188 | 106 | 23 |
| Grade 3 Redness, Dose 2 | 26 | 3 | 0 |
| Any Swelling, Dose 2 | 72 | 31 | 3 |
| Grade 3 Swelling, Dose 2 | 4 | 0 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Any Meningism, Dose 1 | 1 | 0 | 0 |
| Grade 3 Meningism, Dose 1 | 1 | 0 | 0 |
| Related Meningism, Dose 1 | 1 | 0 | 0 |
| Any Meningism, Dose 2 | 0 | 1 | 0 |
| Grade 3 Meningism, Dose 2 | 0 | 0 | 0 |
| Related Meningism, Dose 2 | 0 | 0 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Any Parotitis, Dose 1 | 4 | 5 | 1 |
| Grade 3 Parotitis, Dose 1 | 2 | 1 | 0 |
| Related Parotitis, Dose 1 | 3 | 3 | 0 |
| Any Parotitis, Dose 2 | 0 | 2 | 0 |
| Grade 3 Parotitis, Dose 2 | 0 | 1 | 0 |
| Related Parotitis, Dose 2 | 0 | 1 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Any Localized or Generalized,Dose 1 | 82 | 84 | 30 |
| Any Localized, Dose 1 | 14 | 15 | 6 |
| Localized Admin. site, Dose 1 | 0 | 1 | 0 |
| Localized Other site, Dose 1 | 14 | 14 | 6 |
| Any Generalized, Dose 1 | 68 | 69 | 24 |
| Generalized With fever, Dose 1 | 41 | 41 | 14 |
| Generalized Measles/Rubella, Dose 1 | 30 | 24 | 9 |
| Generalized Grade 3/4, Dose 1 | 9 | 12 | 7 |
| Generalized Grade 4, Dose 1 | 2 | 2 | 4 |
| Generalized Related, Dose 1 | 27 | 32 | 13 |
| Any Localized or Generalized,Dose 2 | 42 | 36 | 9 |
| Any Localized, Dose 2 | 5 | 12 | 4 |
| Localized Admin. site, Dose 2 | 0 | 2 | 0 |
| Localized Other site, Dose 2 | 5 | 10 | 4 |
| Any Generalized, Dose 2 | 37 | 24 | 5 |
| Generalized With fever, Dose 2 | 9 | 11 | 4 |
| Generalized Measles/Rubella, Dose 2 | 8 | 4 | 0 |
| Generalized Grade 3/4, Dose 2 | 5 | 6 | 1 |
| Generalized Grade 4, Dose 2 | 2 | 1 | 0 |
| Generalized Related, Dose 2 | 12 | 6 | 1 |
Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Meningism including febrile convulsions, Dose 1 | 1 | 0 | 0 |
| Meningism including febrile convulsions, Dose 2 | 0 | 1 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Any AE(s), Dose 1 | 301 | 303 | 82 |
| Any AE(s), Dose 2 | 239 | 258 | 90 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs) | 473 | 480 | 148 |
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).
| Hours | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Time lost from work [hours] | 31.5 ± 22.9 | 40.5 ± 31.4 | 48.1 ± 35.3 |
| Time lost for subjects [hours] | 66.4 ± 86.0 | 49.5 ± 31.9 | 54.5 ± 36.4 |
| Time of requested assistance [hours] | 34.0 ± 31.1 | 35.2 ± 51.6 | 35.4 ± 31.3 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase B: Number of Subjects With Confirmed Varicella Case | 38 | 225 | 149 |
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).
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case | 6 | 67 | 176 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase B: Number of Subjects With Probable or Confirmed Varicella Case | 49 | 237 | 152 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Number of varicella cases by subject, 1 | 38 | 223 | 148 |
| Number of varicella cases by subject, 2 | 0 | 2 | 1 |
| Varicella type, Any | 38 | 225 | 149 |
| Varicella type, Confirmed | 38 | 225 | 149 |
| Varicella type, Confirmed PCR | 31 | 207 | 140 |
| Varicella type, Confirmed EPI | 7 | 18 | 9 |
| Varicella type, Confirmed or Probable | 38 | 225 | 149 |
| Varicella type, No case | 0 | 0 | 0 |
| Rash: number of lesions, 1-50 | 32 | 173 | 76 |
| Rash: number of lesions, 51-100 | 5 | 35 | 39 |
| Rash: number of lesions, 101-500 | 1 | 15 | 27 |
| Rash: number of lesions, 501+ | 0 | 0 | 7 |
| Rash: number of lesions, Missing | 0 | 2 | 0 |
| Character of most lesions, Macular | 4 | 6 | 1 |
| Character of most lesions, Papular | 16 | 108 | 63 |
| Character of most lesions, Vesicular | 16 | 100 | 81 |
| Character of most lesions, Haemorragic | 2 | 6 | 4 |
| Character of most lesions, Missing | 0 | 5 | 0 |
| Duration of rash, 0 days | 0 | 0 | 0 |
| Duration of rash, 1-5 days | 23 | 140 | 68 |
| Duration of rash, 6-10 days | 10 | 67 | 61 |
| Duration of rash, 11-15 days | 5 | 13 | 19 |
| Duration of rash, 16+ days | 0 | 0 | 0 |
| Duration of rash, Missing | 0 | 5 | 1 |
| Max. number of lesions [investigator], 1-50 | 32 | 173 | 76 |
| Max. number of lesions [investigator], 51-100 | 5 | 35 | 39 |
| Max. number of lesions [investigator], 101-500 | 1 | 15 | 27 |
| Max. number of lesions [investigator], 501+ | 0 | 0 | 7 |
| Max. number of lesions [investigator], Missing | 0 | 2 | 0 |
| Fever, No fever | 37 | 212 | 100 |
| Fever, 38.8°C to 39.9°C | 1 | 13 | 43 |
| Fever, 40+ °C | 0 | 0 | 6 |
| Systemic sign, Pain in back or abdomen | 6 | 27 | 27 |
| Systemic sign, Interstitial pneumonia | 0 | 0 | 0 |
| Systemic sign, Encephalitis | 0 | 0 | 0 |
| Assessment by investigator, Does not appear ill | 28 | 159 | 62 |
| Assessment by investigator, Moderately ill | 10 | 64 | 80 |
| Assessment by investigator, Severely ill | 0 | 1 | 6 |
| Assessment by investigator, Missing | 0 | 1 | 1 |
| Complications, Yes | 0 | 0 | 0 |
| Complications, No | 38 | 222 | 147 |
| Complications, Missing | 0 | 3 | 2 |
| Treatment, Yes | 15 | 115 | 91 |
| Treatment, No | 23 | 106 | 56 |
| Treatment, Missing | 0 | 4 | 2 |
| Outcome, Recovered/resolved | 38 | 224 | 148 |
| Outcome, Recovered/resolved with sequelae | 0 | 0 | 0 |
| Outcome, Missing | 0 | 1 | 1 |
| Intensity of severity, Mild | 34 | 198 | 91 |
| Intensity of severity, Moderately severe | 4 | 27 | 54 |
| Intensity of severity, Severe | 0 | 0 | 4 |
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
| mIU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-VZV, Year 4 | 501.3 (467.8 to 537.1) | 272.7 (246.2 to 302.1) | 32.4 (26.1 to 40.4) |
| Anti-VZV, Year 6 | 680.6 (635.7 to 728.8) | 417.6 (379.9 to 459.0) | 91.8 (66.3 to 126.9) |
| Anti-VZV, Year 8 | 512.5 (480.3 to 546.8) | 418.5 (383.2 to 457.1) | 146.9 (99.6 to 216.6) |
| Anti-VZV, Year 10 | 471.3 (443.2 to 501.2) | 404.6 (373.0 to 438.8) | 219.6 (149.2 to 323.3) |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-VZV, Year 4 | 1330 | 1061 | 73 |
| Anti-VZV, Year 6 | 1289 | 986 | 97 |
| Anti-VZV, Year 8 | 1142 | 806 | 78 |
| Anti-VZV, Year 10 | 1164 | 818 | 81 |
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
| mIU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-measles, Year 4 | 3290.9 (3025.8 to 3579.2) | 1803.5 (1635.8 to 1988.5) | 1724.4 (1431.7 to 2077.0) |
| Anti-measles, Year 6 | 2795.9 (2544.7 to 3072.0) | 1727.7 (1514.3 to 1971.1) | 1369.0 (1125.7 to 1665.0) |
| Anti-measles, Year 8 | 2342.0 (2115.3 to 2593.0) | 1575.1 (1296.9 to 1913.1) | 1175.5 (963.6 to 1434.0) |
| Anti-measles, Year 10 | 1857.2 (1664.0 to 2072.8) | 997.5 (726.7 to 1369.1) | 913.6 (747.0 to 1117.4) |
The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-measles, Year 4 | 407 | 402 | 131 |
| Anti-measles, Year 6 | 402 | 218 | 128 |
| Anti-measles, Year 8 | 353 | 121 | 113 |
| Anti-measles, Year 10 | 339 | 39 | 109 |
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
| U/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-mumps, Year 4 | 1088.9 (974.9 to 1216.3) | 905.3 (810.0 to 1011.9) | 1059.1 (878.9 to 1276.3) |
| Anti-mumps, Year 6 | 999.7 (897.4 to 1113.7) | 920.5 (800.3 to 1058.8) | 1030.3 (879.1 to 1207.6) |
| Anti-mumps, Year 8 | 875.7 (781.9 to 980.9) | 865.7 (718.3 to 1043.3) | 869.1 (723.3 to 1044.2) |
| Anti-mumps, Year 10 | 889.3 (794.4 to 995.6) | 1054.0 (797.2 to 1393.6) | 912.7 (759.5 to 1096.8) |
The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-mumps, Year 4 | 368 | 357 | 123 |
| Anti-mumps, Year 6 | 360 | 196 | 127 |
| Anti-mumps, Year 8 | 305 | 107 | 108 |
| Anti-mumps, Year 10 | 305 | 36 | 108 |
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).
| IU/mL | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-rubella, Year 4 | 44.4 (40.9 to 48.3) | 50.8 (46.8 to 55.2) | 49.0 (42.9 to 55.9) |
| Anti-rubella, Year 6 | 30.1 (27.9 to 32.4) | 34.0 (30.6 to 37.7) | 33.3 (29.2 to 37.9) |
| Anti-rubella, Year 8 | 20.8 (19.0 to 22.9) | 26.7 (22.7 to 31.5) | 23.3 (19.8 to 27.3) |
| Anti-rubella, Year 10 | 18.8 (17.0 to 20.7) | 29.2 (22.7 to 37.7) | 20.8 (17.6 to 24.6) |
The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Anti-rubella, Year 4 | 407 | 408 | 137 |
| Anti-rubella, Year 6 | 402 | 222 | 136 |
| Anti-rubella, Year 8 | 347 | 120 | 116 |
| Anti-rubella, Year 10 | 334 | 39 | 112 |
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.
| Participants | OKAH Group | MMR Group |
|---|---|---|
| Rash: number of lesions, 1-50 | 4 | 2 |
| Rash: number of lesions, 51-100 | 0 | 0 |
| Rash: number of lesions, 101-500 | 0 | 0 |
| Rash: number of lesions, 501+ | 0 | 0 |
| Character of most lesions, Macular | 0 | 0 |
| Character of most lesions, Papular | 2 | 1 |
| Character of most lesions, Vesicular | 2 | 1 |
| Character of most lesions, Haemorrhagic | 0 | 0 |
| Duration of rash, 0 days | 0 | 0 |
| Duration of rash, 1-5 days | 0 | 1 |
| Duration of rash, 6-10 days | 1 | 0 |
| Duration of rash, 11-15 days | 3 | 1 |
| Duration of rash, 16+ days | 0 | 0 |
| Max. number of lesions [investigator], 1-50 | 4 | 2 |
| Max. number of lesions [investigator], 51-100 | 0 | 0 |
| Max. number of lesions [investigator], 101-500 | 0 | 0 |
| Max. number of lesions [investigator], 501+ | 0 | 0 |
| Fever, No fever | 4 | 2 |
| Fever, 38.8°C to 39.9°C | 0 | 0 |
| Fever, 40+ °C | 0 | 0 |
| Systemic signs, Pain in back or abdomen | 2 | 1 |
| Systemic signs, Interstitial pneumonia | 0 | 0 |
| Systemic signs, Encephalitis | 0 | 0 |
| Assessment by investigator, Does not appear ill | 3 | 2 |
| Assessment by investigator, Moderately ill | 1 | 0 |
| Assessment by investigator, Severely ill | 0 | 0 |
| Complications, Yes | 0 | 0 |
| Complications, No | 4 | 2 |
| Treatment, Yes | 2 | 1 |
| Treatment, No | 2 | 1 |
| Outcome, Recovered/resolved | 4 | 2 |
| Outcome, Recovered/resolved with sequelae | 0 | 0 |
| Intensity of severity, Mild | 4 | 2 |
| Intensity of severity, Moderately severe | 0 | 0 |
| Intensity of severity, Severe | 0 | 0 |
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.
| Participants | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs) | 290 | 317 | 93 |
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).
| Hours | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Time lost from work [hours] | 42.8 ± 44.1 | 44.6 ± 31.1 | 57.8 ± 36.8 |
| Time lost for subjects [hours] | 40.7 ± 35.6 | 48.0 ± 34.1 | 57.2 ± 36.1 |
| Time of requested assistance [hours] | 0 ± 0 | 45.7 ± 21.5 | 49.4 ± 50.0 |
Collected over Solicited local AEs: 4-days (Days 0-3) post dose 1 (Day 0) and dose 2 (Day 42). Solicited general and unsolicited AEs: 43-days (Days 0-42) post dose 1 (Day 0) and dose 2 (Day 42). Serious adverse events: From Day 0 up to the end of study (Year 10).. Non-serious events are listed at a 4.98% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MMRV Group | 1/2,489 (0%) | 649/2,489 (26.1%) | 666/2,489 (26.8%) |
| OKAH Group | 1/2,487 (0%) | 681/2,487 (27.4%) | 641/2,487 (25.8%) |
| MMR Group | 0/827 (0%) | 208/827 (25.2%) | 204/827 (24.7%) |
| Event | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| Adenoidal hypertrophyRespiratory, thoracic and mediastinal disorders | 111/2489 | 123/2487 | 39/827 |
| PneumoniaInfections and infestations | 70/2489 | 63/2487 | 30/827 |
| GastroenteritisInfections and infestations | 67/2489 | 71/2487 | 26/827 |
| BronchitisInfections and infestations | 47/2489 | 51/2487 | 15/827 |
| LaryngitisInfections and infestations | 39/2489 | 45/2487 | 8/827 |
| Gastroenteritis rotavirusInfections and infestations | 27/2489 | 42/2487 | 13/827 |
| GastritisGastrointestinal disorders | 31/2489 | 22/2487 | 9/827 |
| ConcussionInjury, poisoning and procedural complications | 23/2489 | 26/2487 | 7/827 |
| TonsillitisInfections and infestations | 23/2489 | 18/2487 | 7/827 |
| Febrile convulsionNervous system disorders | 21/2489 | 20/2487 | 4/827 |
| Event | MMRV Group | OKAH Group | MMR Group |
|---|---|---|---|
| PyrexiaGeneral disorders | 604/2489 | 574/2487 | 188/827 |
| Injection site erythemaGeneral disorders | 244/2489 | 183/2487 | 43/827 |
| Injection site painGeneral disorders | 124/2489 | 111/2487 | 31/827 |
| Age, Continuous(Months) | MMRV Group | OKAH Group | MMR Group | Total |
|---|---|---|---|---|
| Mean | 14.3 ± 2.5 | 14.2 ± 2.5 | 14.2 ± 2.5 | 14.2 ± 2.5 |
| Sex: Female, Male(Participants) | MMRV Group | OKAH Group | MMR Group | Total |
|---|---|---|---|---|
| Female | 1154 | 1223 | 401 | 2778 |
| Male | 1335 | 1264 | 426 | 3025 |
| Race/Ethnicity, Customized(Participants) | MMRV Group | OKAH Group | MMR Group | Total |
|---|---|---|---|---|
| Race — American hispanic | 1 | 5 | 2 | 8 |
| Race — Arabic/north african | 24 | 7 | 3 | 34 |
| Race — Black | 9 | 9 | 1 | 19 |
| Race — East/south east asian | 8 | 7 | 1 | 16 |
| Race — Japanese | 1 | 0 | 0 | 1 |
| Race — Other | 13 | 11 | 1 | 25 |
| Race — South asian | 3 | 2 | 1 | 6 |
| Race — White/caucasian | 2430 | 2446 | 818 | 5694 |
Showing the first 100 of 104 sites across 10 countries. Choose a country and city above to see the rest.
Plan to share: Yes — IPD for this study will be made available via the Clinical Study Data Request site.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Access criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
Data sharing details ↗ · clinicalstudydatarequest.com
Ran from Sep 2005 to primary completion in Oct 2006, 13 months.
Results were first posted in Sep 2019, 12 years 11 months after primary completion.
Of 35 industry-sponsored phase 3 interventional studies under Chickenpox, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 15. This study's 13 months is close to that.
Counting every sponsor, half of 39 studies reached it within 13 months; a quarter within 9 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Measles-Mumps-Rubella Vaccine · Chickenpox Vaccine