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| ID | Type | Description | Link |
|---|---|---|---|
| V210-058 | Other Identifier | Merck Protocol Number | |
| 2019-003903-36 | EudraCT Number |
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The purpose of this study was to evaluate the immunogenicity and safety of VARIVAX™ vaccine in healthy Russian children, adolescents, and adults. No formal hypothesis was tested.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VARIVAX™ | Experimental | All participants will receive one dose subcutaneous (SC) VARIVAX™ on Day 1. Adult participants and adolescent participants 13 years and older will also receive a second SC dose VARIVAX™ on Day 43. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VARIVAX™ | Biological | VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants). |
| Measure | Description | Time Frame |
|---|---|---|
| Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was <1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
| Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
| VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer <1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a Vaccine Report Card (VRC). The percentage of participants who experienced solicited injection-site AEs after Vaccination 1 (up to approximately 5 days post-vaccination) was summarized for all study arms. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Republican Clinical Infectious Hospital n.a. A.F. Agafonov ( Site 5816) | Kazan' | 420140 | Russia | |||
| Research Institute of Children Infections ( Site 5801) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34702124 | Derived | Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Wittke F, Jotterand V. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy infants, children, and adolescents. Hum Vaccin Immunother. 2021 Nov 2;17(11):4183-4189. doi: 10.1080/21645515.2021.1975451. Epub 2021 Oct 26. | |
| 34473594 |
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150 participants were enrolled and received VARIVAX™ on study. Adults and Adolescents received 2 vaccinations on study and children received 1 vaccination.
This study enrolled healthy Russians aged 12 months and older. Additional inclusion criteria applied.
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| ID | Title | Description |
|---|---|---|
| FG000 | VARIVAX Adults (18 to 75 Years) | Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| FG001 | VARIVAX™ Adolescents 13 to 17 Years of Age | Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| FG002 | VARIVAX™ Children 7 to 12 Years of Age | Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
| FG003 | VARIVAX™ Children 12 Months to 6 Years of Age | Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VARIVAX Adults (18 to 75 Years) | Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | VZV antibody titers were measured using a glycoprotein enzyme-linked immunosorbent assay (gpELISA). The VZV antibody response rate was defined as the percentage of participants with a post-vaccination VZV antibody titer ≥5 gpELISA units/mL for participants whose baseline VZV antibody titer was <1.25 gpELISA units/mL. VZV antibody response rate was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seronegative at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
Adverse Events: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days); All-Cause Mortality: Up to approximately 16 months
All-Cause Mortality, Serious adverse events (AEs), and Other AE tables include all allocated participants. All allocated participants on study received at least 1 dose of study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VARIVAX Adults (18 to 75 Years) | Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 18, 2019 | Mar 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline | GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group. | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
| Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline | GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group. | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
| Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline | GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group. | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
| Up to approximately 5 days post-Vaccination 1 |
| Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a VRC. The percentage of participants who experienced solicited injection-site AEs after Vaccination 2 (up to approximately 5 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days) |
| Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to approximately 42 days post-Vaccination 1 |
| Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
| Percentage of Participants With Elevated Temperature Post-Vaccination 1 | The participant's temperature was taken in the evening after Vaccination 1 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 1 (up to approximately 28 days post-vaccination) was summarized for all study arms. | Up to 28 days post-Vaccination 1 |
| Percentage of Participants With Elevated Temperature Post-Vaccination 2 | The participant's temperature was taken in the evening after Vaccination 2 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 2 (up to approximately 28 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | Up to 28 days post-Vaccination 2 (up to approximately 71 days) |
| Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1 | The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to approximately 42 days post-Vaccination 1 |
| Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2 | The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
| Percentage of Participants With Systemic AEs Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to approximately 42 days post-Vaccination 1 |
| Percentage of Participants With Systemic AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
| Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event. The percentage of participants who experienced one or more SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
| Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced one or more vaccine-related SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
| Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced a vaccine-related SAE that resulted in death after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
| Saint Petersburg |
| 197022 |
| Russia |
| SPb Pasteur RI of Epidemiology and Microbiology ( Site 5817) | Saint Petersburg | 197101 | Russia |
| Smolensk State Medical University ( Site 5814) | Smolensk | 214019 | Russia |
| Smolensk State Medical University ( Site 5815) | Smolensk | 214019 | Russia |
| Paradis EM, Tikhonov O, Cao X, Kharit SM, Fokin A, Platt HL, Banniettis N. Phase 3, open-label, Russian, multicenter, single-arm trial to evaluate the immunogenicity of varicella vaccine (VARIVAX) in healthy adults. Hum Vaccin Immunother. 2021 Nov 2;17(11):4177-4182. doi: 10.1080/21645515.2021.1957414. Epub 2021 Sep 2. |
| VARIVAX™ Adolescents 13 to 17 Years of Age |
Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| BG002 | VARIVAX™ Children 7 to 12 Years of Age | Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
| BG003 | VARIVAX™ Children 12 Months to 6 Years of Age | Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| Serostatus for Varicella-Zoster Virus (VZV) | VZV seronegative status at baseline was VZV antibody titer <1.25 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL at baseline. A VZV seropositive status at baseline was a VZV antibody titer ≥1.25 gpELISA units/mL). | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | VARIVAX Adults (18 to 75 Years) | Participants aged 18 to 75 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| OG001 | VARIVAX™ Adolescents 13 to 17 Years of Age | Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. |
| OG002 | VARIVAX™ Children 7 to 12 Years of Age | Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
| OG003 | VARIVAX™ Children 12 Months to 6 Years of Age | Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. |
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| Primary | Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seronegative at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
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| Primary | VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline | VZV antibody levels were measured using a gpELISA. The VZW antibody seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL in participants with a baseline VZV antibody titer <1.25 gpELISA units/mL. VZW antibody seroconversion was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seronegative to VZW at baseline. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seronegative at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days) |
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| Primary | GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline | GMTs of VZV antibodies were measured post-vaccination using a gpELISA. GMT was calculated at each time point by taking the log of the titers, averaging over all participants values, and then back-transforming to the original scale. GMT was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, confidence intervals (CIs) were only calculated when there were at least 5 participants who were seropositive in a treatment group. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seropositive at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
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| Primary | Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline | GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the GMFR was calculated as the ratio of the VZV GMT at 6 weeks post last vaccination to the VZV GMT at Day 1 (baseline). The GMFR from Day 1 was reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents) for participants who were seropositive to VZW at baseline. Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seropositive at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Geometric Mean | 95% Confidence Interval | Ratio | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
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| Primary | Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post Last Vaccination Among Participants Who Were Seropositive at Baseline | GMTs were measured using a gpELISA. For participants who were seropositive at baseline (baseline VZV antibody titer ≥1.25 gpELISA units/mL), the percentage of participants with a ≥4-fold rise in VZV antibody titer from Day 1 (baseline) to post-vaccination was assessed and reported for all study arms at 6 weeks post last vaccination (Vaccination 1 for children and Vaccination 2 for adults and adolescents). Per protocol, CIs were only calculated when there were at least 5 participants who were seropositive in a treatment group. | All allocated participants without deviations from the protocol that would substantially affect the results of the immunogenicity outcome measures (Per-Protocol population) who were seropositive at baseline and who received Vaccination 1 (children) or Vaccination 1 and Vaccination 2 (adults and adolescents) were analyzed. | Posted | Number | 95% Confidence Interval | Percentage of participants | Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents) |
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| Secondary | Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a Vaccine Report Card (VRC). The percentage of participants who experienced solicited injection-site AEs after Vaccination 1 (up to approximately 5 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to approximately 5 days post-Vaccination 1 |
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| Secondary | Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Solicited injection-site AEs, which included erythema, pain, and swelling, were recorded on a VRC. The percentage of participants who experienced solicited injection-site AEs after Vaccination 2 (up to approximately 5 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. Per protocol, the two children study arms did not receive a second vaccination and were excluded from this analysis. | Posted | Number | Percentage of participants | Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days) |
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| Secondary | Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 1 |
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| Secondary | Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. Per protocol, the two children study arms did not receive a second vaccination and were excluded from this analysis. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
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| Secondary | Percentage of Participants With Elevated Temperature Post-Vaccination 1 | The participant's temperature was taken in the evening after Vaccination 1 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 1 (up to approximately 28 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to 28 days post-Vaccination 1 |
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| Secondary | Percentage of Participants With Elevated Temperature Post-Vaccination 2 | The participant's temperature was taken in the evening after Vaccination 2 and daily through Day 28, and was recorded on a VRC. An elevated temperature was defined as ≥39.0 °C (102.2 °F). The percentage of participants with elevated temperature after Vaccination 2 (up to approximately 28 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. Per protocol, the two children study arms did not receive a second vaccination and were excluded from this analysis. | Posted | Number | Percentage of participants | Up to 28 days post-Vaccination 2 (up to approximately 71 days) |
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| Secondary | Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1 | The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 1 |
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| Secondary | Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2 | The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants who experienced varicella-like and herpes zoster-like rashes after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. Per protocol, the two children study arms did not receive a second vaccination and were excluded from this analysis. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
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| Secondary | Percentage of Participants With Systemic AEs Post-Vaccination 1 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 1 (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 1 |
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| Secondary | Percentage of Participants With Systemic AEs Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A systemic AE was defined as any non-injection-site AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE after Vaccination 2 (up to approximately 42 days post-vaccination) was summarized for all study arms receiving a second vaccination (adults and adolescents). | All allocated participants who received two doses of study vaccine (adults and adolescents) and who had some safety follow-up data after the respective vaccination were analyzed. Per protocol, the two children study arms did not receive a second vaccination and were excluded from this analysis. | Posted | Number | Percentage of participants | Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days) |
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| Secondary | Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event. The percentage of participants who experienced one or more SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
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| Secondary | Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced one or more vaccine-related SAEs after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
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| Secondary | Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2 | An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. A vaccine-related SAE was an AE that resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or another important medical event, that was considered at least possibly related to the study vaccine. The percentage of participants who experienced a vaccine-related SAE that resulted in death after either vaccination (up to approximately 42 days post-vaccination) was summarized for all study arms. | All allocated participants who received at least one dose of study vaccine and who had some safety follow-up data after the respective vaccination were analyzed. | Posted | Number | Percentage of participants | Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days) |
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| 0 |
| 50 |
| 0 |
| 50 |
| 40 |
| 50 |
| EG001 | VARIVAX Adolescents (13 to 17 Years) | Participants aged 13 to 17 years of age received 2 doses of VARIVAX™ administered approximately six weeks apart: one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1, and a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. | 0 | 30 | 0 | 30 | 17 | 30 |
| EG002 | VARIVAX Children (7 to 12 Years) | Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | 0 | 33 | 1 | 33 | 15 | 33 |
| EG003 | VARIVAX Children (12 Months to 6 Years) | Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | 0 | 37 | 0 | 37 | 16 | 37 |
| Injection site haemorrhage | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site pain | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Respiratory tract infection viral | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Body temperature increased | Investigations | MedDRA 23.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
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| Rash vesicular | Skin and subcutaneous tissue disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site erythema | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Injection site swelling | General disorders | MedDRA 23.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 23.0 | Systematic Assessment |
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The Sponsor will comply with the requirements for publication of study results. In accordance with standard editorial and ethical practice, the Sponsor will generally support publication of multicenter studies only in their entirety and not as individual site data. If publication activity is not directed by the Sponsor, investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| D007239 | Infections |
| D045424 |
| Complex Mixtures |
| Post Last Vaccination |
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| Injection-site pain |
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| Injection-site swelling |
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| Injection-site swelling |
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| Herpes zoster-like rash |
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