Trial Outcomes & Findings for Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed) (NCT NCT00822237)
NCT ID: NCT00822237
Last Updated: 2017-04-12
Results Overview
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
598 participants
Primary outcome timeframe
6 weeks following first vaccination
Results posted on
2017-04-12
Participant Flow
Participant milestones
| Measure |
VARIVAX 2007 Process + M-M-R II
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
VARIVAX 1999 Process + M-M-R II
VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
|---|---|---|
|
Dose 1 Vaccination
STARTED
|
299
|
299
|
|
Dose 1 Vaccination
COMPLETED
|
274
|
273
|
|
Dose 1 Vaccination
NOT COMPLETED
|
25
|
26
|
|
Dose 2 Vaccination
STARTED
|
274
|
273
|
|
Dose 2 Vaccination
COMPLETED
|
270
|
262
|
|
Dose 2 Vaccination
NOT COMPLETED
|
4
|
11
|
Reasons for withdrawal
| Measure |
VARIVAX 2007 Process + M-M-R II
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
VARIVAX 1999 Process + M-M-R II
VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
|---|---|---|
|
Dose 1 Vaccination
Not vaccinated
|
3
|
0
|
|
Dose 1 Vaccination
Withdrawal by Subject
|
13
|
14
|
|
Dose 1 Vaccination
Lost to Follow-up
|
9
|
12
|
|
Dose 2 Vaccination
Withdrawal by Subject
|
2
|
2
|
|
Dose 2 Vaccination
Lost to Follow-up
|
2
|
9
|
Baseline Characteristics
Study to Test the Safety and Immunogenicity of VARIVAX (2007 Process) (Study V210-057) (Completed)
Baseline characteristics by cohort
| Measure |
VARIVAX 2007 Process + M-M-R II
n=299 Participants
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
VARIVAX 1999 Process + M-M-R II
n=299 Participants
VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
Total
n=598 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.0 months
STANDARD_DEVIATION 1.83 • n=5 Participants
|
13.0 months
STANDARD_DEVIATION 1.83 • n=7 Participants
|
13.0 months
STANDARD_DEVIATION 1.83 • n=5 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=5 Participants
|
138 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
161 Participants
n=7 Participants
|
302 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeks following first vaccinationPopulation: Per protocol population
Percent of participants with varicella antibody titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) units/mL in participants with baseline varicella antibody titer \< 1.25 gpELISA units/mL. Results for the VARIVAX (1999 Process) arm are not included in this table because the primary outcome measure is for the VARIVAX (2007 Process) arm only.
Outcome measures
| Measure |
VARIVAX 2007 Process + M-M-R II
n=246 Participants
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection \~6 weeks apart
|
|---|---|
|
Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
|
96.3 Percent of participants
|
Adverse Events
VARIVAX 2007 Process + M-M-R II
Serious events: 1 serious events
Other events: 189 other events
Deaths: 0 deaths
VARIVAX 1999 Process + M-M-R II
Serious events: 1 serious events
Other events: 156 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VARIVAX 2007 Process + M-M-R II
n=296 participants at risk
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection \~6 weeks apart
|
VARIVAX 1999 Process + M-M-R II
n=299 participants at risk
VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection \~6 weeks apart
|
|---|---|---|
|
Infections and infestations
Croup infectious
|
0.34%
1/296 • Number of events 1
Number of participants at risk for the 2007 process is the number who received the first dose.
|
0.00%
0/299
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
0.00%
0/296
Number of participants at risk for the 2007 process is the number who received the first dose.
|
0.33%
1/299 • Number of events 1
Number of participants at risk for the 2007 process is the number who received the first dose.
|
Other adverse events
| Measure |
VARIVAX 2007 Process + M-M-R II
n=296 participants at risk
VARIVAX (2007 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection \~6 weeks apart
|
VARIVAX 1999 Process + M-M-R II
n=299 participants at risk
VARIVAX (1999 process) in two 0.5 mL doses by injection \~6 weeks apart
M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by
injection \~6 weeks apart
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
24/296 • Number of events 27
Number of participants at risk for the 2007 process is the number who received the first dose.
|
5.7%
17/299 • Number of events 24
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
20/296 • Number of events 23
Number of participants at risk for the 2007 process is the number who received the first dose.
|
4.3%
13/299 • Number of events 15
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
General disorders
Injection site erythema
|
22.6%
67/296 • Number of events 134
Number of participants at risk for the 2007 process is the number who received the first dose.
|
21.4%
64/299 • Number of events 137
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
General disorders
Injection site pain
|
28.4%
84/296 • Number of events 205
Number of participants at risk for the 2007 process is the number who received the first dose.
|
23.4%
70/299 • Number of events 167
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
General disorders
Injection site swelling
|
10.8%
32/296 • Number of events 69
Number of participants at risk for the 2007 process is the number who received the first dose.
|
11.7%
35/299 • Number of events 63
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
General disorders
Irritability
|
9.1%
27/296 • Number of events 34
Number of participants at risk for the 2007 process is the number who received the first dose.
|
5.0%
15/299 • Number of events 21
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
General disorders
Pyrexia
|
25.0%
74/296 • Number of events 110
Number of participants at risk for the 2007 process is the number who received the first dose.
|
21.7%
65/299 • Number of events 92
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Infections and infestations
Otitis media
|
10.5%
31/296 • Number of events 33
Number of participants at risk for the 2007 process is the number who received the first dose.
|
7.4%
22/299 • Number of events 25
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.8%
20/296 • Number of events 24
Number of participants at risk for the 2007 process is the number who received the first dose.
|
6.7%
20/299 • Number of events 22
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.1%
12/296 • Number of events 17
Number of participants at risk for the 2007 process is the number who received the first dose.
|
5.4%
16/299 • Number of events 18
Number of participants at risk for the 2007 process is the number who received the first dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.1%
21/296 • Number of events 24
Number of participants at risk for the 2007 process is the number who received the first dose.
|
5.0%
15/299 • Number of events 16
Number of participants at risk for the 2007 process is the number who received the first dose.
|
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 study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
- Publication restrictions are in place
Restriction type: OTHER