Trial Outcomes & Findings for Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058) (NCT NCT03843632)
NCT ID: NCT03843632
Last Updated: 2021-04-06
Results Overview
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.
COMPLETED
PHASE3
150 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)
2021-04-06
Participant Flow
This study enrolled healthy Russians aged 12 months and older. Additional inclusion criteria applied.
150 participants were enrolled and received VARIVAX™ on study. Adults and Adolescents received 2 vaccinations on study and children received 1 vaccination.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
50
|
30
|
33
|
37
|
|
Overall Study
Vaccination 1
|
50
|
30
|
33
|
37
|
|
Overall Study
Vaccination 2
|
49
|
30
|
0
|
0
|
|
Overall Study
COMPLETED
|
49
|
30
|
33
|
37
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Evaluation of the Immunogenicity and Safety of VARIVAX™ in Healthy Russians (V210-058)
Baseline characteristics by cohort
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.7 years
STANDARD_DEVIATION 6.0 • n=99 Participants
|
15.1 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
9.6 years
STANDARD_DEVIATION 1.6 • n=206 Participants
|
3.2 years
STANDARD_DEVIATION 1.6 • n=7 Participants
|
14.2 years
STANDARD_DEVIATION 9.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
84 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
19 Participants
n=7 Participants
|
66 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
48 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
148 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
50 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
150 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Serostatus for Varicella-Zoster Virus (VZV)
VZV Seronegative
|
26 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
34 Participants
n=7 Participants
|
100 Participants
n=31 Participants
|
|
Serostatus for Varicella-Zoster Virus (VZV)
VZV Seropositive
|
24 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
50 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=26 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=18 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=22 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=34 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Varicella Zoster Virus (VZV) Antibody Response Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
|
100.0 Percentage of participants
Interval 86.8 to 100.0
|
100.0 Percentage of participants
Interval 81.5 to 100.0
|
95.5 Percentage of participants
Interval 77.2 to 99.9
|
100.0 Percentage of participants
Interval 89.7 to 100.0
|
PRIMARY outcome
Timeframe: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=26 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=18 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=22 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=34 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Geometric Mean Titers (GMTs) of VZV Antibodies at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
|
70.7 gpELISA units/mL
95% Confidence Interval 47.9 • Interval 47.9 to 104.2
|
78.6 gpELISA units/mL
95% Confidence Interval 46.5 • Interval 46.5 to 133.0
|
11.3 gpELISA units/mL
95% Confidence Interval 7.3 • Interval 7.3 to 17.5
|
13.9 gpELISA units/mL
95% Confidence Interval 11.2 • Interval 11.2 to 17.2
|
PRIMARY outcome
Timeframe: Adults and Adolescents: 6 weeks post Vaccination 2 (up to approximately 86 days), Children: 6 weeks post Vaccination 1 (up to approximately 43 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=26 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=18 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=22 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=34 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
VZV Antibody Seroconversion Rate at 6 Weeks Post Last Vaccination in Participants Who Were Seronegative at Baseline
|
100.0 Percentage of participants
95% Confidence Interval 86.8 • Interval 86.8 to 100.0
|
100.0 Percentage of participants
95% Confidence Interval 81.5 • Interval 81.5 to 100.0
|
95.5 Percentage of participants
95% Confidence Interval 77.2 • Interval 77.2 to 99.9
|
100.0 Percentage of participants
95% Confidence Interval 89.7 • Interval 89.7 to 100.0
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=23 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=12 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=11 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=3 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
Day 1 (Baseline)
|
71.1 gpELISA units/mL
Interval 31.4 to 161.2
|
13.4 gpELISA units/mL
Interval 5.8 to 31.0
|
24.8 gpELISA units/mL
Interval 7.2 to 85.5
|
4.2 gpELISA units/mL
Per protocol, CIs were not calculated when \<5 participants were seropositive in a treatment group.
|
|
GMTs of VZV Antibodies at Day 1 and 6 Weeks Post Last Vaccination in Participants Who Were Seropositive at Baseline
Post Last Vaccination
|
216.7 gpELISA units/mL
Interval 132.8 to 353.6
|
151.7 gpELISA units/mL
Interval 92.5 to 248.6
|
125.0 gpELISA units/mL
Interval 37.9 to 411.7
|
47.6 gpELISA units/mL
Per protocol, CIs were not calculated when \<5 participants were seropositive in a treatment group.
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=23 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=12 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=11 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=3 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
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
|
3.0 Ratio
Interval 2.0 to 4.8
|
11.3 Ratio
Interval 4.6 to 27.5
|
5.0 Ratio
Interval 2.6 to 9.7
|
11.2 Ratio
Per protocol, CIs were not calculated when \<5 participants were seropositive in a treatment group.
|
PRIMARY outcome
Timeframe: Day 1 (Baseline), 6 weeks post last vaccination (Day 43 for children and Day 84 for adults and adolescents)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=23 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=12 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=11 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=3 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
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
|
60.9 Percentage of participants
Interval 38.5 to 80.3
|
66.7 Percentage of participants
Interval 34.9 to 90.1
|
54.5 Percentage of participants
Interval 23.4 to 83.3
|
100.0 Percentage of participants
Per protocol, CIs were not calculated when \<5 participants were seropositive in a treatment group.
|
SECONDARY outcome
Timeframe: Up to approximately 5 days post-Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
Injection-site erythema
|
16.0 Percentage of participants
|
3.3 Percentage of participants
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
Injection-site pain
|
40.0 Percentage of participants
|
23.3 Percentage of participants
|
30.3 Percentage of participants
|
13.5 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-Site Adverse Events (AEs) Post-Vaccination 1
Injection-site swelling
|
10.0 Percentage of participants
|
0.0 Percentage of participants
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 5 days post-Vaccination 2 (up to approximately 48 days)Population: 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.
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).
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=49 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
Injection-site erythema
|
18.4 Percentage of participants
|
0 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
Injection-site pain
|
49.0 Percentage of participants
|
23.3 Percentage of participants
|
—
|
—
|
|
Percentage of Participants With Solicited Injection-Site AEs Post-Vaccination 2
Injection-site swelling
|
8.2 Percentage of participants
|
3.3 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 1
|
2.0 Percentage of participants
|
3.3 Percentage of participants
|
0.0 Percentage of participants
|
5.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)Population: 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.
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).
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=49 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Unsolicited Injection-Site AEs Post-Vaccination 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days post-Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Elevated Temperature Post-Vaccination 1
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
3.0 Percentage of participants
|
8.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 28 days post-Vaccination 2 (up to approximately 71 days)Population: 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.
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).
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=49 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Elevated Temperature Post-Vaccination 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
Varicella-like rash
|
6.0 Percentage of participants
|
0.0 Percentage of participants
|
6.1 Percentage of participants
|
2.7 Percentage of participants
|
|
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 1
Herpes zoster-like rash
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)Population: 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.
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).
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=49 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Varicella- and Herpes Zoster-Like Rashes Post-Vaccination 2
|
2.0 Percentage of participants
|
0.0 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 1Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic AEs Post-Vaccination 1
|
38.0 Percentage of participants
|
23.3 Percentage of participants
|
36.4 Percentage of participants
|
43.2 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to approximately 42 days post-Vaccination 2 (up to approximately 86 days)Population: 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.
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).
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=49 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
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.
|
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.
|
|---|---|---|---|---|
|
Percentage of Participants With Systemic AEs Post-Vaccination 2
|
28.6 Percentage of participants
|
26.7 Percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With 1 or More Serious Adverse Events (SAEs) Post-Vaccination 1 or Post-Vaccination 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
3.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Vaccine-Related SAEs Post-Vaccination 1 or Post-Vaccination 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days post-Vaccination 1 or post-Vaccination 2 (up to approximately 86 days)Population: 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.
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.
Outcome measures
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 Participants
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.
|
VARIVAX™ Adolescents 13 to 17 Years of Age
n=30 Participants
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.
|
VARIVAX™ Children 7 to 12 Years of Age
n=33 Participants
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX™ Children 12 Months to 6 Years of Age
n=37 Participants
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Percentage of Participants With Vaccine-Related Death Post-Vaccination 1 or Post-Vaccination 2
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
Adverse Events
VARIVAX Adults (18 to 75 Years)
VARIVAX Adolescents (13 to 17 Years)
VARIVAX Children (7 to 12 Years)
VARIVAX Children (12 Months to 6 Years)
Serious adverse events
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 participants at risk
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.
|
VARIVAX Adolescents (13 to 17 Years)
n=30 participants at risk
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.
|
VARIVAX Children (7 to 12 Years)
n=33 participants at risk
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX Children (12 Months to 6 Years)
n=37 participants at risk
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Nervous system disorders
Headache
|
0.00%
0/50 • 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.
|
0.00%
0/30 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
0.00%
0/37 • 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.
|
Other adverse events
| Measure |
VARIVAX Adults (18 to 75 Years)
n=50 participants at risk
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.
|
VARIVAX Adolescents (13 to 17 Years)
n=30 participants at risk
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.
|
VARIVAX Children (7 to 12 Years)
n=33 participants at risk
Participants aged 7 to 12 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
VARIVAX Children (12 Months to 6 Years)
n=37 participants at risk
Participants aged 12 months to 6 years of age received one 0.5 mL dose of VARIVAX™ administered by SC injection on Day 1.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/50 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
5.4%
2/37 • Number of events 2 • 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.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/50 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
5.4%
2/37 • Number of events 2 • 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.
|
|
General disorders
Injection site pain
|
58.0%
29/50 • Number of events 45 • 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.
|
33.3%
10/30 • Number of events 14 • 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.
|
30.3%
10/33 • Number of events 10 • 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.
|
13.5%
5/37 • Number of events 5 • 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.
|
|
Infections and infestations
Respiratory tract infection
|
2.0%
1/50 • Number of events 1 • 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.
|
0.00%
0/30 • 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.
|
6.1%
2/33 • Number of events 2 • 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.
|
13.5%
5/37 • Number of events 5 • 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.
|
|
Infections and infestations
Respiratory tract infection viral
|
2.0%
1/50 • Number of events 1 • 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.
|
6.7%
2/30 • Number of events 2 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
10.8%
4/37 • Number of events 6 • 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.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/50 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
5.4%
2/37 • Number of events 2 • 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.
|
|
Investigations
Body temperature increased
|
12.0%
6/50 • Number of events 11 • 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.
|
16.7%
5/30 • Number of events 10 • 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.
|
6.1%
2/33 • Number of events 2 • 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.
|
24.3%
9/37 • Number of events 13 • 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.
|
|
Nervous system disorders
Headache
|
18.0%
9/50 • Number of events 15 • 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.
|
20.0%
6/30 • Number of events 10 • 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.
|
15.2%
5/33 • Number of events 5 • 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.
|
0.00%
0/37 • 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.
|
|
Skin and subcutaneous tissue disorders
Rash vesicular
|
6.0%
3/50 • Number of events 4 • 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.
|
0.00%
0/30 • 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.
|
6.1%
2/33 • Number of events 2 • 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.
|
2.7%
1/37 • Number of events 1 • 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.
|
|
General disorders
Injection site erythema
|
32.0%
16/50 • Number of events 17 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
0.00%
0/37 • 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.
|
|
General disorders
Injection site swelling
|
14.0%
7/50 • Number of events 9 • 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.
|
3.3%
1/30 • Number of events 1 • 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.
|
3.0%
1/33 • Number of events 1 • 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.
|
0.00%
0/37 • 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.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
6.0%
3/50 • Number of events 6 • 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.
|
0.00%
0/30 • 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.
|
0.00%
0/33 • 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.
|
0.00%
0/37 • 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.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER