Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
This study will compare Measles, Mumps, Rubella, and Varicella Vaccine (V221) and concomitant administration of Varivax and M-M-R II vaccines in healthy children.
Interventions
a single 0.5 mL subcutaneous injection of V221 at Day 0 and Day 90
BIOLOGICALComparator: Placebo
a single 0.5 mL subcutaneous placebo injection at Day 0
BIOLOGICALComparator: Varivax
a single 0.5 mL subcutaneous injection of Varivax at Day 0
BIOLOGICALComparator: M-M-R II
a single 0.5 mL subcutaneous injection of M-M-R II at Day 0
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Months to 23 Months
Healthy volunteers
Yes
Inclusion criteria
* In good health * Negative clinical history of varicella, shingles, measles, mumps, and rubella
Exclusion criteria
* Previous receipt of measles, mumps, rubella and/or varicella vaccine either alone or in combination * Any immune impairment or deficiency * Exposure to measles, mumps, rubella, varicella, or zoster in the 4 weeks prior to vaccination * Vaccination with an inactive vaccine with in the past 14 days * Vaccination with a live vaccine within the past 30 days * Immune globulin or any blood product administered in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | 6 weeks Postvaccination | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | 6 weeks Postvaccination | Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<207.8 mIU/mL) to Measles at Baseline |
| Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline | 6 weeks Postvaccination | Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline |
| Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | 6 weeks Postvaccination | Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<2.0 Ab Units/mL) to Mumps at Baseline |
| Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 6 weeks Postvaccination | Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline |
Participant flow
Recruitment details
2 clinical sites in the United States Date of first participant visit: 24-Mar-1998 Date of last participant visit: 05-Jan-1999
Participants by arm
| Arm | Count |
|---|---|
| ProQuad™ + Placebo Followed by ProQuad™ ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (\
40,000 PFU/0.5 mL-dose) with a standard measles component (\
3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (\
40,000 PFU/0.5 mL-dose) with a standard measles component (\
3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose. | 323 |
| M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0. | 157 |
| Total | 480 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 1 |
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 3 |
Baseline characteristics
| Characteristic | M-M-R™ II + VARIVAX™ | Total | ProQuad™ + Placebo Followed by ProQuad™ |
|---|---|---|---|
| Age, Continuous | 14.0 Months STANDARD_DEVIATION 1.7 | 14.1 Months STANDARD_DEVIATION 1.8 | 14.1 Months STANDARD_DEVIATION 1.9 |
| Race/Ethnicity, Customized African American | 21 participants | 62 participants | 41 participants |
| Race/Ethnicity, Customized Asian/Pacific | 9 participants | 39 participants | 30 participants |
| Race/Ethnicity, Customized Caucasian | 107 participants | 318 participants | 211 participants |
| Race/Ethnicity, Customized Hispanic | 16 participants | 46 participants | 30 participants |
| Race/Ethnicity, Customized Other | 4 participants | 15 participants | 11 participants |
| Sex: Female, Male Female | 87 Participants | 260 Participants | 173 Participants |
| Sex: Female, Male Male | 70 Participants | 220 Participants | 150 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 238 / 321 | 190 / 308 | 110 / 156 |
| serious Total, serious adverse events | 0 / 321 | 1 / 308 | 1 / 156 |
Outcome results
Primary
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer of \<0.6 gpELISA units/mL) to Varicella at Baseline
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | 228 Participants |
| ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | 237 Participants |
| M-M-R™ II + VARIVAX™ (1 Injection) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL for Subjects Initially Seronegative (a Titer of <0.6 gpELISA Units/mL) to Varicella at Baseline | 118 Participants |
Secondary
Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL
Antibody Response to Measles at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<207.8 mIU/mL) to Measles at Baseline
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) | Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | 290 Participants |
| ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) | Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | 284 Participants |
| M-M-R™ II + VARIVAX™ (1 Injection) | Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL | 145 Participants |
Secondary
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL
Antibody Response to Mumps at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<2.0 Ab Units/mL) to Mumps at Baseline
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | 292 Participants |
| ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | 283 Participants |
| M-M-R™ II + VARIVAX™ (1 Injection) | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL | 148 Participants |
Secondary
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL
Antibody Response to Rubella at 6 Weeks Postvaccination for Subjects Initially Seronegative (a titer \<10 IU/mL) to Rubella at Baseline
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 289 Participants |
| ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 275 Participants |
| M-M-R™ II + VARIVAX™ (1 Injection) | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL | 142 Participants |
Secondary
Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline
Antibody Response to Varicella at 6 Weeks Postvaccination for Subjects Initially With Varicella Antibody Titer \<1.25 gpELISA units/mL at Baseline
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, Varicella Antibody Titer \<1.25 gpELISA units/mL at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline | 264 Participants |
| ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline | 275 Participants |
| M-M-R™ II + VARIVAX™ (1 Injection) | Number of Participants With Postvaccination Varicella Antibody Titer ≥5 gpELISA Units/mL for Subjects Initially With Varicella Antibody Titer <1.25 gpELISA Units/mL at Baseline | 134 Participants |