Varicella
Conditions
Brief summary
This study will test the safety, tolerability, and immunogenicity of VARIVAX manufactured with the 2007 commercial Varicella-Zoster Virus (VZV) bulk process when concomitantly administered with M-M-R II in healthy children.
Detailed description
This treatment has been approved for sale to the public.
Interventions
BIOLOGICALVaricella Virus Vaccine Live (2007 Process) (Oka/Merck)
VARIVAX (2007 process) in two 0.5 mL doses by injection \ 6 weeks apart
BIOLOGICALComparator: Varicella Virus Vaccine Live (1999 Process) (Oka/Merck)
VARIVAX (1999 process) in two 0.5 mL doses by injection \ 6 weeks apart
BIOLOGICALMeasles, Mumps, and Rubella Virus Vaccine Live (MMR)
M-M-R II in two 0.5 mL doses by injection \ 6 weeks apart
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* Subject is in good health based on medical history * Subject has no history of measles, mumps, rubella, chickenpox, or shingles
Exclusion criteria
* Subject has previously received measles, mumps, rubella, and/or varicella vaccine either alone or in combination * Subject has history of immune disorders * Subject has been exposed to chickenpox/shingles, measles, mumps, rubella or varicella within 4 weeks of study start * Subject has received an inactivated vaccine within 14 days of first dose of study vaccine * Subject has received a live vaccine within 30 days of first dose of study vaccine * Subject has received a blood transfusion or blood-derived products within 3 months of receiving study vaccine * Subject has had a fever within 72 hours of study start
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | 6 weeks following first vaccination | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 299 |
| 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 | 299 |
| Total | 598 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Dose 1 Vaccination | Lost to Follow-up | 9 | 12 |
| Dose 1 Vaccination | Not vaccinated | 3 | 0 |
| Dose 1 Vaccination | Withdrawal by Subject | 13 | 14 |
| Dose 2 Vaccination | Lost to Follow-up | 2 | 9 |
| Dose 2 Vaccination | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | VARIVAX 2007 Process + M-M-R II | VARIVAX 1999 Process + M-M-R II | Total |
|---|---|---|---|
| Age, Continuous | 13.0 months STANDARD_DEVIATION 1.83 | 13.0 months STANDARD_DEVIATION 1.83 | 13.0 months STANDARD_DEVIATION 1.83 |
| Sex: Female, Male Female | 158 Participants | 138 Participants | 296 Participants |
| Sex: Female, Male Male | 141 Participants | 161 Participants | 302 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 189 / 296 | 156 / 299 |
| serious Total, serious adverse events | 1 / 296 | 1 / 299 |
Outcome results
Primary
Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process).
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.
Time frame: 6 weeks following first vaccination
Population: Per protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VARIVAX 2007 Process + M-M-R II | Percent of Participants Who Achieved Varicella Immunogenicity After a Single Dose of VARIVAX (2007 Process). | 96.3 Percent of participants |