Trial Outcomes & Findings for Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063) (NCT NCT02062502)
NCT ID: NCT02062502
Last Updated: 2018-10-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
611 participants
Primary outcome timeframe
6 weeks (43 days) after vaccination 1
Results posted on
2018-10-30
Participant Flow
Participant milestones
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Overall Study
STARTED
|
306
|
305
|
|
Overall Study
Vaccinated Dose 1
|
306
|
305
|
|
Overall Study
COMPLETED
|
263
|
270
|
|
Overall Study
NOT COMPLETED
|
43
|
35
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Immunogenicity and Safety of VARIVAX™ New Seed Process (NSP) in Children (V210-063)
Baseline characteristics by cohort
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=306 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=305 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
Total
n=611 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.9 Months
STANDARD_DEVIATION 1.9 • n=5 Participants
|
12.8 Months
STANDARD_DEVIATION 1.7 • n=7 Participants
|
12.9 Months
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
140 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
279 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks (43 days) after vaccination 1Population: The analysis population is participants with a seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=254 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=254 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 Glycoprotein Enzyme-linked Immunosorbent Assay (gpELISA) Units/mL
|
97.2 Percentage of participants
|
97.2 Percentage of participants
|
PRIMARY outcome
Timeframe: 6 weeks (43 days) after vaccination 1Population: The analysis population is participants with seronegative antibody titer at baseline and postvaccination serology contributing to the per-protocol analysis.
Antibody titers were measured with gpELISA.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=254 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=254 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Geometric Mean Titer of VZV Antibodies
|
16.28 gpELISA units/mL
Interval 15.11 to 17.55
|
17.2 gpELISA units/mL
Interval 15.86 to 18.65
|
SECONDARY outcome
Timeframe: Up to 42 days after Vaccination 1 and Vaccination 2 (up to 133 days)Population: The analysis population is All Subjects as Treated with temperature data at the time of assessment.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=291 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=293 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm 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: n=285, 287
|
9.5 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Fever (>=102.2 °F Oral Equivalent)
Up to 42 days after Vaccination 2: n=258, 267
|
8.1 Percentage of participants
|
8.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after Vaccination 1Population: The analysis population is All Subjects as Treated with results after Vaccination 1.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=291 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=293 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Measles-like Rash
|
0.3 Percentage of participants
|
2.4 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Rubella-like Rash
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Varicella-like Rash
|
0.0 Percentage of participants
|
0.3 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Mumps-like Symptoms
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 1
Injection-site Rash
|
0.3 Percentage of participants
|
1.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 42 days after Vaccination 2Population: The analysis population is All Subjects as Treated with results after vaccination 2
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=277 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=276 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Measles-like Rash
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Rubella-like Rash
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Varicella-like Rash
|
0.4 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Mumps-like Symptoms
|
0.0 Percentage of participants
|
0.0 Percentage of participants
|
|
Percentage of Participants With Systemic Measles-like, Rubella-like, Varicella-like Rash, Mumps-like Symptoms, and Injection-site Rash After Vaccination 2
Injection-site Rash
|
0.7 Percentage of participants
|
0.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after Vaccination 1Population: The analysis population is All Subjects as Treated with results after Vaccination 1.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=291 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=293 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm 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 1
Injection-site Erythema
|
20.3 Percentage of participants
|
19.8 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Injection-site Swelling
|
10.0 Percentage of participants
|
10.6 Percentage of participants
|
|
Percentage of Participants With Solicited Injection-site Erythema, Injection-site Swelling, and Injection-site Pain/Tenderness After Vaccination 1
Injection-site Pain/Tenderness
|
29.9 Percentage of participants
|
28.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 5 days after Vaccination 2Population: The analysis population is All Subjects as Treated with results after vaccination 2.
Outcome measures
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=277 Participants
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=276 Participants
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm 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
|
20.6 Percentage of participants
|
22.5 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
|
16.2 Percentage of participants
|
12.0 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/Tenderness
|
22.4 Percentage of participants
|
24.3 Percentage of participants
|
Adverse Events
VARIVAX™ New Seed Process + M-M-R II™
Serious events: 6 serious events
Other events: 225 other events
Deaths: 0 deaths
VARIVAX™ 2007 Process + M-M-R II™
Serious events: 9 serious events
Other events: 224 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=291 participants at risk
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=293 participants at risk
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
General disorders
Drowning
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
1.0%
3/293 • Number of events 3 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Gastroenteritis
|
0.69%
2/291 • Number of events 2 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.00%
0/293 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Lobar pneumonia
|
0.34%
1/291 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.00%
0/293 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Otitis media acute
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Pneumonia
|
0.34%
1/291 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.00%
0/293 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.69%
2/291 • Number of events 2 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.34%
1/291 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.34%
1/291 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.00%
0/293 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.34%
1/291 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.00%
0/293 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Status asthmaticus
|
0.00%
0/291 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
0.34%
1/293 • Number of events 1 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
Other adverse events
| Measure |
VARIVAX™ New Seed Process + M-M-R II™
n=291 participants at risk
VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
VARIVAX™ 2007 Process + M-M-R II™
n=293 participants at risk
VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
12.7%
37/291 • Number of events 42 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
7.5%
22/293 • Number of events 25 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Gastrointestinal disorders
Vomiting
|
9.6%
28/291 • Number of events 34 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
6.1%
18/293 • Number of events 21 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
General disorders
Injection site erythema
|
32.6%
95/291 • Number of events 181 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
32.1%
94/293 • Number of events 190 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
General disorders
Injection site pain
|
36.4%
106/291 • Number of events 272 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
39.9%
117/293 • Number of events 270 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
General disorders
Injection site swelling
|
21.0%
61/291 • Number of events 110 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
20.1%
59/293 • Number of events 96 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
General disorders
Pyrexia
|
20.6%
60/291 • Number of events 86 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
20.5%
60/293 • Number of events 87 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Conjunctivitis
|
4.1%
12/291 • Number of events 12 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
5.1%
15/293 • Number of events 15 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Otitis media
|
12.0%
35/291 • Number of events 38 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
11.3%
33/293 • Number of events 36 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Otitis media acute
|
7.9%
23/291 • Number of events 24 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
4.8%
14/293 • Number of events 16 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.8%
46/291 • Number of events 59 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
15.0%
44/293 • Number of events 51 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Infections and infestations
Viral rash
|
2.1%
6/291 • Number of events 6 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
5.8%
17/293 • Number of events 18 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Psychiatric disorders
Irritability
|
5.8%
17/291 • Number of events 18 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
4.4%
13/293 • Number of events 18 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.2%
18/291 • Number of events 20 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
8.5%
25/293 • Number of events 29 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.1%
9/291 • Number of events 9 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
5.8%
17/293 • Number of events 18 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
10.7%
31/291 • Number of events 37 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
8.9%
26/293 • Number of events 35 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
8.6%
25/291 • Number of events 28 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
9.2%
27/293 • Number of events 30 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.9%
23/291 • Number of events 27 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
4.8%
14/293 • Number of events 14 • SAEs: up to Day 271; Other AEs: up to 42 days after vaccination 1 or 2, injection-site AEs up to 5 days after vaccination 1 or 2
The at-risk safety population is All Subjects as Treated with safety results.
|
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.
- Publication restrictions are in place
Restriction type: OTHER