Clinical Trial Results:
An Open-Label, Multicenter, Single-arm Study to Evaluate the Immunogenicity of VARIVAX™ in Healthy Russian Individuals 12 Months of Age and Older
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Summary
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EudraCT number |
2019-003903-36 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
19 Jun 2020
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Results information
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Results version number |
v1 |
This version publication date |
20 Dec 2020
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First version publication date |
20 Dec 2020
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
V210-058
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03843632 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Jun 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
19 Jun 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
19 Jun 2020
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The purpose of this study was to evaluate the immunogenicity of VARIVAX™ vaccine in healthy Russians aged 12 months and older. No formal hypothesis was tested.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Mar 2019
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Russian Federation: 100
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Worldwide total number of subjects |
100
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
64
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Adolescents (12-17 years) |
36
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||
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Pre-assignment
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Screening details |
This study enrolled in healthy Russians aged 12 months and older. Additional inclusion criteria applied. | ||||||||||||||||||||
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Period 1
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Period 1 title |
Overall study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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VARIVAX™ Adolescents 13 to 17 years of age | ||||||||||||||||||||
Arm description |
Participants received one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1. Participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
VARIVAX™
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Investigational medicinal product code |
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Other name |
Varicella Virus Vaccine Live
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. Participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43.
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Arm title
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VARIVAX™ Children 7 to 12 years of age | ||||||||||||||||||||
Arm description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
VARIVAX
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Investigational medicinal product code |
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Other name |
Varicella Virus Vaccine Live
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
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Arm title
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VARIVAX™ Children 12 months to 6 years of age | ||||||||||||||||||||
Arm description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | ||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||
Investigational medicinal product name |
VARIVAX
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Investigational medicinal product code |
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Other name |
Varicella Virus Vaccine Live
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
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| Notes [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Only adolescents 13 to 17 years of age received Vaccination 2. [2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left. Justification: Only adolescents 13 to 17 years of age received Vaccination 2. |
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Baseline characteristics reporting groups
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Reporting group title |
VARIVAX™ Adolescents 13 to 17 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1. Participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
VARIVAX™ Children 7 to 12 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
VARIVAX™ Children 12 months to 6 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
VARIVAX™ Adolescents 13 to 17 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by subcutaneous (SC) injection on Day 1. Participants 13 to 17 years of age also received a second 0.5 mL dose of VARIVAX™ by SC injection on Day 43. | ||
Reporting group title |
VARIVAX™ Children 7 to 12 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | ||
Reporting group title |
VARIVAX™ Children 12 months to 6 years of age
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Reporting group description |
Participants received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1. | ||
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End point title |
Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seronegative at Baseline [1] [2] | ||||||||
End point description |
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 VZV antibody titer ≥5 gpELISA units/mL at 6 weeks post-Vaccination 2. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 2
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seronegative at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
VZV Antibody Response Rate at 6 Weeks Post-Vaccination 1 in Children Who Were Seronegative at Baseline [3] [4] | ||||||||||||
End point description |
VZV antibody titers were measured using a gpELISA. The VZV antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 gpELISA units/mL at 6 weeks post-Vaccination 1. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 1
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seronegative at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seronegative at Baseline [5] [6] | ||||||||
End point description |
Geometric mean titers of VZV antibodies were measured at 6 weeks post-Vaccination 2 using a gpELISA. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 2
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [6] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seronegative at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
GMTs of VZV Antibodies at 6 Weeks Post-Vaccination 1 in Children Who Were Seronegative at Baseline [7] [8] | ||||||||||||
End point description |
Geometric mean titers of VZV antibodies were measured at 6 weeks post-Vaccination 1 using a gpELISA. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 1
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seronegative at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
VZV Antibody Seroconversion Rate at 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seronegative at Baseline [9] [10] | ||||||||
End point description |
VZV antibody levels were measured using a gpELISA. The seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL at 6 weeks post-Vaccination 2. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 2
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| Notes [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [10] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seronegative at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
VZV Antibody Seroconversion Rate at 6 Weeks Post-Vaccination 1 in Children Who Were Seronegative at Baseline [11] [12] | ||||||||||||
End point description |
VZV antibody levels were measured using a gpELISA. The seroconversion rate was defined as the percentage of participants with VZV antibodies ≥1.25 gpELISA units/mL at 6 weeks post-Vaccination 1. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seronegative at baseline and received Vaccination 1.
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End point type |
Primary
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End point timeframe |
6 weeks post-Vaccination 1
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| Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seronegative at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seropositive at Baseline [13] [14] | ||||||||||||
End point description |
GMTs of VZV antibodies were measured using a gpELISA. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
Day 1 and 6 weeks post-Vaccination 2
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| Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seropositive at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post-Vaccination 1 in Children Who Were Seropositive at Baseline [15] [16] | ||||||||||||||||||
End point description |
Geometric mean titers of VZV antibodies were measured using a gpELISA. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1. Note: Confidence intervals were only calculated when there were at least 5 participants who were seropositive in a treatment group.
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End point type |
Primary
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End point timeframe |
Day 1 and 6 weeks post-Vaccination 1
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| Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seropositive at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Geometric Mean Fold Rise (GMFR) in VZV Antibody Titers From Day 1 to 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seropositive at Baseline [17] [18] | ||||||||
End point description |
GMTs were measured using a gpELISA. The GMFR was the ratio of the VZV antibody concentration at 6 weeks post-Vaccination 2 to the VZV antibody concentration at Day 1 (baseline). The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
Day 1 (baseline) and 6 weeks post-Vaccination 2
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| Notes [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only adolescents 13 to 17 years of age who were seropositive at baseline and received Vaccination 2 were included in this endpoint. [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seropositive at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
GMFR in VZV Antibody Titers From Day 1 to 6 Weeks Post-Vaccination 1 in Children Who Were Seropositive at Baseline [19] [20] | ||||||||||||
End point description |
GMTs were measured using a gpELISA. The GMFR was the ratio of the VZV antibody concentration at 6 weeks post-Vaccination 1 to the VZV antibody concentration at Day 1 (baseline). The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1. Note: Confidence intervals were only calculated when there were at least 5 participants who were seropositive in a treatment group.
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End point type |
Primary
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End point timeframe |
Day 1 (baseline) and 6 weeks post-Vaccination 1
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| Notes [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint. [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seropositive at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With ≥4-Fold Rise in Antibody Titers From Day 1 to 6 Weeks Post-Vaccination 2 in Adolescents Who Were Seropositive at Baseline [21] [22] | ||||||||
End point description |
The percentage of participants with a ≥4-fold rise from Day 1 baseline (≥1.25gpELISA units/mL) to 6 weeks post-Vaccination 2 was assessed. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1 and Vaccination 2.
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End point type |
Primary
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End point timeframe |
Day 1 (baseline) and 6 weeks post-Vaccination 2
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| Notes [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint. [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who were seropositive at baseline and received Vaccination 2 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Percentage of Participants With ≥4-Fold Rise in VZV Antibody Titers From Day 1 to 6 Weeks Post-Vaccination 1 in Children Who Were Seropositive at Baseline [23] [24] | ||||||||||||
End point description |
The percentage of participants with a ≥4-fold rise from Day 1 baseline (≥1.25gpELISA units/mL) to 6 weeks post-Vaccination 1 was assessed. The analysis population for this endpoint included all randomized participants without deviations from the protocol who were seropositive at baseline and received Vaccination 1. Note: Confidence intervals were only calculated when there were at least 5 participants who were seropositive in a treatment group.
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End point type |
Primary
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End point timeframe |
Day 1 (baseline) and 6 weeks post-Vaccination 1
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| Notes [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: There were no between-group statistical analyses for this endpoint. [24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only children 12 months to 6 years of age and 7 to 12 years of age who were seropositive at baseline and received Vaccination 1 were included in this endpoint. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1 | ||||||||||||||||||||||||||||
End point description |
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 was summarized. The analysis population for this end point included all randomized participants who received Vaccination 1.
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End point type |
Secondary
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End point timeframe |
Up to 5 days post-Vaccination 1
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
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End point title |
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2 [25] | ||||||||||||||
End point description |
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 was summarized. The analysis population for this end point included all randomized participants who received Vaccination 2.
|
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End point type |
Secondary
|
||||||||||||||
End point timeframe |
Up to 5 days post-Vaccination 2
|
||||||||||||||
| Notes [25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who received Vaccination 2 were included in this endpoint. |
|||||||||||||||
|
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| No statistical analyses for this end point | |||||||||||||||
|
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End point title |
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1 | ||||||||||||||||
End point description |
Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 1 was summarized. The analysis population for this end point included all randomized participants who received Vaccination 1.
|
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End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||
End point title |
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2 [26] | ||||||||
End point description |
Unsolicited injection-site AEs were recorded on a VRC. The percentage of participants who experienced unsolicited injection-site AEs after Vaccination 2 was summarized. The analysis population for this end point included all randomized participants who received Vaccination 2.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 42 days post-Vaccination 2
|
||||||||
| Notes [26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who received Vaccination 2 were included in this endpoint. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
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End point title |
Percentage of Participants With Elevated Temperature Post-Vaccination 1 | ||||||||||||||||
End point description |
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 an elevated temperature was summarized. The analysis population for this end point included all randomized participants who received Vaccination 1.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 28 days post-Vaccination 1
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||
End point title |
Percentage of Participants With Elevated Temperature Post-Vaccination 2 [27] | ||||||||
End point description |
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 an elevated temperature was summarized. The analysis population for this end point included all randomized participants who received Vaccination 2.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 28 days post-Vaccination 2
|
||||||||
| Notes [27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who received Vaccination 2 were included in this endpoint |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||||||||||
End point title |
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1 | ||||||||||||||||||||||||
End point description |
The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants with varicella-like and herpes zoster-like rashes was summarized. The analysis population for this end point included all randomized participants who received Vaccination 1.
|
||||||||||||||||||||||||
End point type |
Secondary
|
||||||||||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||||||||||
|
|||||||||
End point title |
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2 [28] | ||||||||
End point description |
The development of varicella-like and herpes zoster-like rashes was recorded on a VRC. The percentage of participants with varicella-like and herpes zoster-like rashes was summarized. The analysis population for this end point included all randomized participants who received Vaccination 2.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 42 days post-Vaccination 2
|
||||||||
| Notes [28] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who received Vaccination 2 were included in this endpoint. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||
End point title |
Percentage of Participants With Systemic AEs Post-Vaccination 1 | ||||||||||||||||
End point description |
A systemic AE was defined as any non-injection-site AE. An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. Systemic AEs were recorded on a VRC. The percentage of participants who experienced a systemic AE was summarized. The analysis population for this end point included all randomized participants who received Vaccination 1.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||
End point title |
Percentage of Participants With Systemic AEs Post-Vaccination 2 [29] | ||||||||
End point description |
A systemic AE was defined as any non-injection-site AE. An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with study drug. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study drug or a protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the study drug or protocol-specified procedure is also an AE. The participant was to record the presence of any VRC-prompted systemic AEs that occurred up to 42 days post-Vaccination 2. The percentage of participants with a systemic AE was summarized. The analysis population for this end point included all randomized participants who received Vaccination 2.
|
||||||||
End point type |
Secondary
|
||||||||
End point timeframe |
Up to 42 days post-Vaccination 2
|
||||||||
| Notes [29] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Only adolescents 13 to 17 years of age who received Vaccination 2 were included in this endpoint. |
|||||||||
|
|||||||||
| No statistical analyses for this end point | |||||||||
|
|||||||||||||||||
End point title |
Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2 | ||||||||||||||||
End point description |
An SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event. The percentage of participants with 1 or more SAEs was summarized. The analysis population for this end point included all randomized participants who received at least 1 dose of study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1 or post-Vaccination 2
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2 | ||||||||||||||||
End point description |
A vaccine-related SAE is an AE that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or another important medical event that is considered at least possibly related to the study vaccine. The percentage of participants that experienced 1 or more vaccine-related SAEs was summarized. The analysis population for this end point included all randomized participants who received at least 1 dose of study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1 or post-Vaccination 2
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||
End point title |
Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2 | ||||||||||||||||
End point description |
The percentage of participants that experienced 1 or more SAEs that were considered at least possibly related to the study vaccine and resulted in a death was summarized. The analysis population for this end point included all randomized participants who received at least 1 dose of study vaccination.
|
||||||||||||||||
End point type |
Secondary
|
||||||||||||||||
End point timeframe |
Up to 42 days post-Vaccination 1 or post-Vaccination 2
|
||||||||||||||||
|
|||||||||||||||||
| No statistical analyses for this end point | |||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
Adverse events information
|
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Timeframe for reporting adverse events |
Up to 42 days post-Vaccination 1 or post-Vaccination 2
|
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Adverse event reporting additional description |
The safety population included all randomized participants who received at least 1 dose of study vaccination.
|
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
23.0
|
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Reporting groups
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Reporting group title |
VARIVAX Children (7 to 12 years)
|
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
VARIVAX Children (12 months to 6 years)
|
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
VARIVAX Adolescents (13 to 17 years)
|
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
||
06 Dec 2012 |
Amendment 1: The primary reason for the amendment was to change the pregnancy/contraceptive follow-up
period text so that it was consistent with the Investigator Brochure and the Product Label. |
||
18 Apr 2013 |
Amendment 2: The primary reasons for this amendment were to update the study design to include the enrollment targets by age groups and specify the primary immunogenicity and
safety endpoints of the study; and to add laboratory tests for
participants 7 years of age and older. |
||
03 Oct 2018 |
Amendment 3: The primary reasons for this amendment were to edit the title of the study remove “safety” and “tolerability” and to align it with the study’s primary focus of immunogenicity, and make its secondary objective that of safety and tolerability. The study design was also revised to include an adult cohort with a target enrollment of 50 participants. This cohort is referred to as Stage 1. Stage 2 would then enroll children and adolescents and follow sequentially after Stage 1. Additionally, the ages of
children and adolescent participants in Stage 2 of the study were specified. |
||
18 Dec 2018 |
Amendment 4: The primary reason for this amendment was to add an exclusion criterion to exclude participants who had (or their parents had) a documented human immunodeficiency virus (HIV) infection, untreated syphilis infection or viral
hepatitis infection (Hepatitis B or C). |
||
30 Jul 2019 |
Amendment 5: The primary reason for this amendment was to align the protocol with the current version of the Common Protocol Template (CPT). |
||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
