| Primary | Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL | The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers <1.25 gpELISA units/mL) at baseline. | The analysis population included the number of participants with seronegative antibody titer (<1.25 gpELISA units/mL) at baseline and postvaccination serology. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 6 weeks (43 days) after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG00098.4(95.9 to 99.6)
- OG00198.3(95.8 to 99.5)
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| | Miettinen and Nurminen | | <0.001 | | Risk Difference (RD) | 0.0 | | | 2-Sided | 95 | -2.7 | 2.8 | | | | | Non-Inferiority | The conclusion of non-inferiority (similarity) is based on the lower bound of the 2-sided 95% CI on the risk difference excluding a decrease equal to or more than the prespecified criterion of 10.0 percentage points for Varicella zoster virus. | | |
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| Primary | Geometric Mean Titer of VZV Antibodies | The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA. | The analysis population included the number of participants with seronegative antibody titer (<1.25 gpELISA units/mL) at baseline and postvaccination serology. | Posted | | Geometric Mean | 95% Confidence Interval | gpELISA units/mL | | 6 weeks (43 days) after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Fever (≥102.2 °F Oral Equivalent) | The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with temperature data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1; Up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%) | The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%) | The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1 | The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 5 days after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2 | The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 5 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Adverse Events | An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II |
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| Secondary | Percentage of Participants With One or More Serious Adverse Events | A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs ~180 days after vaccination 2 was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to ~180 days after vaccination 2 (Up to ~285 days) | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Vaccine-Related Adverse Events | The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4) | All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0) | All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL) | The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA. | The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data. | Posted | | Number | 95% Confidence Interval | Percentage of Participants | | 6 weeks (~43 days) after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody | Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive. | The analysis population consisted of all participants with with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data. | Posted | | Geometric Mean | 95% Confidence Interval | Ratio | | Baseline and 6 weeks (~43 days) after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody | The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed. | The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) and available postvaccination serology data. | Posted | | Geometric Mean | 95% Confidence Interval | Percentage of Participants | | Baseline and 6 weeks (~43 days) after vaccination 1 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Vaccine-Related Serious Adverse Events | The percentage of participants with one or more vaccine-related serious adverse events up to ~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to ~180 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants Who Discontinued From the Study Due to an Adverse Event | The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 | | | | ID | Title | Description |
|---|
| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%) | The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 1 | | | | ID | Title | Description |
|---|
| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%) | The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was >0% in one or more vaccination groups after rounding. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentage of Participants | | Up to 42 days after vaccination 2 | | | | ID | Title | Description |
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| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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| Secondary | Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%) | The percentage of participants with medically-attended AEs up to ~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported. | The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment. | Posted | | Number | | Percentge of Participants | | Up to ~180 days after vaccination 2 (Up to ~285 days) | | | | ID | Title | Description |
|---|
| OG000 | VARIVAX PE34 + M-M-R II | VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. | | OG001 | VARIVAX (2016 CP) + M-M-R II | 2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91. |
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