Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03) (NCT NCT03239873)
NCT ID: NCT03239873
Last Updated: 2021-01-27
Results Overview
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
600 participants
Primary outcome timeframe
6 weeks (43 days) after vaccination 1
Results posted on
2021-01-27
Participant Flow
Participant milestones
| Measure |
VARIVAX PE34 + M-M-R II
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Overall Study
STARTED
|
300
|
300
|
|
Overall Study
Vaccination 1
|
299
|
300
|
|
Overall Study
Vaccination 2
|
276
|
282
|
|
Overall Study
COMPLETED
|
268
|
273
|
|
Overall Study
NOT COMPLETED
|
32
|
27
|
Reasons for withdrawal
| Measure |
VARIVAX PE34 + M-M-R II
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
15
|
16
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
12
|
11
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Contraindication to study medication
|
1
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Evaluation of Immunogenicity and Safety of VARIVAX® Passage Extension 34 (PE34) Process in Children (V210-A03)
Baseline characteristics by cohort
| Measure |
VARIVAX PE34 + M-M-R II
n=300 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.0 Months
STANDARD_DEVIATION 1.4 • n=5 Participants
|
13.2 Months
STANDARD_DEVIATION 1.7 • n=7 Participants
|
13.1 Months
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
153 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
280 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
147 Participants
n=5 Participants
|
173 Participants
n=7 Participants
|
320 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
46 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
106 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
254 Participants
n=5 Participants
|
237 Participants
n=7 Participants
|
491 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
35 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
237 Participants
n=5 Participants
|
239 Participants
n=7 Participants
|
476 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
23 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (43 days) after vaccination 1Population: The analysis population included the number of participants with seronegative antibody titer (\<1.25 gpELISA units/mL) at baseline and postvaccination serology.
The varicella zoster virus (VZV) antibody response rate was defined as the percentage of participants with VZV antibody titer ≥5 glycoprotein enzyme-linked immunosorbent assay (gpELISA) units/mL among participants who were seronegative to VZV (titers \<1.25 gpELISA units/mL) at baseline.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=245 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=239 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Varicella Zoster Virus Antibody Levels ≥5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
|
98.4 Percentage of Participants
Interval 95.9 to 99.6
|
98.3 Percentage of Participants
Interval 95.8 to 99.5
|
PRIMARY outcome
Timeframe: 6 weeks (43 days) after vaccination 1Population: The analysis population included the number of participants with seronegative antibody titer (\<1.25 gpELISA units/mL) at baseline and postvaccination serology.
The geometric mean titer (GMT) of VZV antibodies after vaccination 1 was assessed. Antibody titers were measured with gpELISA.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=245 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=239 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Geometric Mean Titer of VZV Antibodies
|
18.5 gpELISA units/mL
Interval 17.1 to 20.1
|
19.0 gpELISA units/mL
Interval 17.6 to 20.5
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1; Up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with temperature data at the time of assessment.
The percentage of participants with fever ≥102.2 °F oral equivalent for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
Up to 42 days after Vaccination 1
|
11.8 Percentage of Participants
|
9.8 Percentage of Participants
|
|
Percentage of Participants With Fever (≥102.2 °F Oral Equivalent)
Up to 42 days after Vaccination 2
|
8.9 Percentage of Participants
|
6.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was \>0% in one or more vaccination groups after rounding.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Measles-like rash
|
0.3 Percentage of Participants
|
1.7 Percentage of Participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Rubella-like rash
|
0.3 Percentage of Participants
|
0.0 Percentage of Participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Varicella-like rash
|
2.7 Percentage of Participants
|
1.3 Percentage of Participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 1 (Incidence > 0%)
Zoster-like rash
|
0.0 Percentage of Participants
|
0.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with measles-like, rubella-like, varicella-like, zoster-like rash, and mumps-like symptoms after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was \>0% in one or more vaccination groups after rounding.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=276 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=282 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
Measles-like rash
|
1.4 Percentage of Participants
|
0.4 Percentage of Participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
Varicella-like rash
|
0.4 Percentage of Participants
|
0.7 Percentage of Participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like, Zoster-like Rash, and Mumps-like Symptoms After Vaccination 2 (Incidence > 0%)
Zoster-like rash
|
0.4 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccination 1Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with solicited (on a Vaccine Report Card) injection-site erythema, injection-site swelling, or injection-site pain/tenderness was assessed.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
Injection site erythema
|
9.7 Percentage of Participants
|
10.7 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
Injection site pain
|
13.4 Percentage of Participants
|
12.7 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, or Injection-site Pain/Tenderness After Vaccination 1
Injection site swelling
|
3.0 Percentage of Participants
|
5.7 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 5 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with solicited (Vaccine Report Card) injection-site erythema, injection-site swelling, and injection-site pain/tenderness was assessed.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=276 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=282 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Injection site erythema
|
19.6 Percentage of Participants
|
19.9 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Injection site pain
|
8.7 Percentage of Participants
|
10.3 Percentage of Participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 2
Injection site swelling
|
10.1 Percentage of Participants
|
8.2 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol - specified procedure, whether or not considered related to the medicinal product or protocol - specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally associated with the use of the Sponsor's product, is also an AE. The percentage of participants with one or more adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Adverse Events
|
90.0 Percentage of Participants
|
88.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~180 days after vaccination 2 (Up to ~285 days)Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
A serious adverse event (SAE) is defined as an adverse event that resulted in death, was life threatening, resulted in persistent or significant disability or incapacity, resulted in or prolonged a hospitalization, is a congenital anomaly or birth defect, is a cancer, was an overdose, or was an important medical event based on appropriate medical judgment. The percentage of participants with one or more SAEs \~180 days after vaccination 2 was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Serious Adverse Events
|
2.0 Percentage of Participants
|
2.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with one or more vaccine-related adverse events for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Vaccine-Related Adverse Events
|
56.2 Percentage of Participants
|
54.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 1. The percentage of participants with one or more systemic adverse events (incidence ≥4 participants in one or more of the vaccination groups) was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 1 (Incidence ≥ 4)
|
76.6 Percentage of Participants
|
74.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
All systemic adverse events were recorded on an electronic vaccination report card (eVRC) for Day 1 through Day 42 after vaccination 2. The percentage of participants with one or more systemic adverse events was assessed. A specific adverse event was reported only if its incidence was \>0% in one or more vaccination groups after rounding.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=276 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=282 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Systemic Adverse Events After Vaccination 2 (Incidence > 0)
|
60.9 Percentage of Participants
|
59.9 Percentage of Participants
|
SECONDARY outcome
Timeframe: 6 weeks (~43 days) after vaccination 1Population: The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.
The percentage of participants with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and postvaccination serology contributing to the per-protocol analysis was assessed. Confidence interval is calculated if there are at least 5 subjects who are seropositive. Antibody titers were assessed using gpELISA.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=31 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=40 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Immunogenicity to Varicella Zoster Virus in Participants Initially Seropositive to Varicella Zoster Virus Antibody (≥ 5gpELISA Units/mL)
|
100.0 Percentage of Participants
Interval 88.8 to 100.0
|
97.5 Percentage of Participants
Interval 86.8 to 99.9
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks (~43 days) after vaccination 1Population: The analysis population consisted of all participants with with seropositive antibody titer (≥1.25gpELISA units/mL) at baseline and with available postvaccination serology data.
Blood samples were taken at pre-vaccination (baseline) and approximately 43 days after vaccination 1 to determine the geometric mean titer (GMT) of VZV antibodies via gpELISA. The geometric mean fold rise (GMFR) was calculated as GMT post vaccination 1/GMT pre-vaccination (baseline). Confidence interval is calculated if there are at least 5 subjects who are seropositive.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=31 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=40 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Geometric Mean Fold Rise From Baseline in Varicella Zoster Virus Antibody Titer in Participants Initially Seropositive to Varicella Zoster Virus Antibody
|
6.5 Ratio
Interval 5.0 to 8.5
|
7.2 Ratio
Interval 5.9 to 8.9
|
SECONDARY outcome
Timeframe: Baseline and 6 weeks (~43 days) after vaccination 1Population: The analysis population consisted of all participants with seropositive antibody titer (≥1.25gpELISA units/mL) and available postvaccination serology data.
The percentage of participants with a geometric mean ≥4-fold rise from baseline of ≥1.25gpELISA units/mL in VZV antibody titer at approximately 43 days after vaccination 1 was assessed.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=31 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=40 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With a ≥4-fold Rise From Baseline in Varicella Zoster Virus Antibody Titers in Participants Initially Seropositive to Varicella Zoster Virus Antibody
|
80.6 Percentage of Participants
Interval 62.5 to 92.5
|
82.5 Percentage of Participants
Interval 67.2 to 92.7
|
SECONDARY outcome
Timeframe: Up to ~180 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with one or more vaccine-related serious adverse events up to \~180 days after vaccination 2 was reported. The study investigator determines whether the serious adverse event is related to the vaccine.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Vaccine-Related Serious Adverse Events
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1 and up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants discontinued from the study due to an adverse event for Day 1 through Day 42 after vaccination 1 and Day 1 through Day 42 after vaccination 2 was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants Who Discontinued From the Study Due to an Adverse Event
|
0.0 Percentage of Participants
|
0.0 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 1Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 1 was assessed. A specific adverse event was reported only if its incidence was \>0% in one or more vaccination groups after rounding.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=299 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 1 (Incidence > 0%)
|
8.0 Percentage of Participants
|
9.3 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to 42 days after vaccination 2Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with unsolicited injection-site adverse events (or AEs not superficially listed on eVRC) for Day 1 through Day 42 after vaccination 2 was assessed. A specific adverse event was reported only if its incidence was \>0% in one or more vaccination groups after rounding.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=276 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=282 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With One or More Unsolicited Injection-Site Adverse Events After Vaccination 2 (Incidence > 0%)
|
1.4 Percentage of Participants
|
2.1 Percentage of Participants
|
SECONDARY outcome
Timeframe: Up to ~180 days after vaccination 2 (Up to ~285 days)Population: The analysis population consisted of all randomized/allocated participants who received at least 1 vaccination of study treatment with data at the time of assessment.
The percentage of participants with medically-attended AEs up to \~180 days after vaccination 2 that did not meet the definition of serious adverse event (incidence ≥5% in one or more vaccination groups) was reported.
Outcome measures
| Measure |
VARIVAX PE34 + M-M-R II
n=275 Participants
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=282 Participants
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Medically-Attended Adverse Events (Incidence ≥5%)
|
29.5 Percentge of Participants
|
26.6 Percentge of Participants
|
Adverse Events
VARIVAX PE34 + M-M-R II
Serious events: 6 serious events
Other events: 255 other events
Deaths: 0 deaths
VARIVAX (2016 CP) + M-M-R II
Serious events: 6 serious events
Other events: 240 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VARIVAX PE34 + M-M-R II
n=299 participants at risk
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 participants at risk
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Infections and infestations
Adenovirus infection
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Croup infectious
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Gastroenteritis
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.67%
2/299 • Number of events 2 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Enterovirus infection
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Osteomyelitis
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Pharyngeal abscess
|
0.33%
1/299 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.00%
0/300 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Nervous system disorders
Febrile convulsion
|
0.00%
0/299 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
0.33%
1/300 • Number of events 1 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
Other adverse events
| Measure |
VARIVAX PE34 + M-M-R II
n=299 participants at risk
VARIVAX® Passage Extension 34 (PE34) Process 0.5 mL administered in the left arm or thigh and M-M-R®II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX (2016 CP) + M-M-R II
n=300 participants at risk
2016 Commercial Process vaccine 0.5 mL administered in the left arm or thigh and M-M-R® II vaccine 0.5 mL administered in the right arm or thigh by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.7%
26/299 • Number of events 33 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
6.7%
20/300 • Number of events 30 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Gastrointestinal disorders
Teething
|
9.0%
27/299 • Number of events 34 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
16.7%
50/300 • Number of events 63 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Gastrointestinal disorders
Vomiting
|
12.0%
36/299 • Number of events 40 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
14.0%
42/300 • Number of events 47 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
General disorders
Injection site bruising
|
4.0%
12/299 • Number of events 14 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
5.3%
16/300 • Number of events 19 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
General disorders
Injection site erythema
|
28.4%
85/299 • Number of events 158 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
29.0%
87/300 • Number of events 157 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
General disorders
Injection site pain
|
18.4%
55/299 • Number of events 129 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
19.7%
59/300 • Number of events 125 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
General disorders
Injection site swelling
|
15.7%
47/299 • Number of events 66 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
14.3%
43/300 • Number of events 64 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
General disorders
Pyrexia
|
32.4%
97/299 • Number of events 134 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
25.0%
75/300 • Number of events 111 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Hand-foot-and-mouth disease
|
5.7%
17/299 • Number of events 18 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
3.3%
10/300 • Number of events 10 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Nasopharyngitis
|
11.0%
33/299 • Number of events 38 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
14.7%
44/300 • Number of events 49 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Otitis media
|
11.7%
35/299 • Number of events 41 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
8.7%
26/300 • Number of events 29 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Otitis media acute
|
8.0%
24/299 • Number of events 24 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
9.0%
27/300 • Number of events 29 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Infections and infestations
Upper respiratory tract infection
|
12.4%
37/299 • Number of events 41 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
16.3%
49/300 • Number of events 58 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Psychiatric disorders
Irritability
|
16.7%
50/299 • Number of events 74 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
17.0%
51/300 • Number of events 70 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
17.7%
53/299 • Number of events 66 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
18.7%
56/300 • Number of events 68 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
16.1%
48/299 • Number of events 76 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
14.7%
44/300 • Number of events 50 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
13.0%
39/299 • Number of events 46 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
11.0%
33/300 • Number of events 44 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.4%
25/299 • Number of events 38 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
9.0%
27/300 • Number of events 37 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
11.7%
35/299 • Number of events 40 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
21.7%
65/300 • Number of events 78 • Up to 42 days after vaccination 1 and up to 42 days after vaccination 2 for all non-serious adverse events; Up to 180 days after vaccination 2 for all serious adverse events.
The analysis population consisted of all randomized/allocated participants who received at least 1 dose of trial treatment.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER