Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
Interventions
a single 0.5 mL subcutaneous injection of ProQuad (low, middle, or high dose) at Day 0 and Day 90
BIOLOGICALComparator: M-M-R II
A single 0.5 mL subcutaneous injection at Day 0
BIOLOGICALComparator: PUVV
A single 0.5 mL subcutaneous injection 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 measles, mumps, rubella, varicella, and zoster
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 Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 6 weeks postvaccination | Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 in participants 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 in participants initially seronegative (a titer \<10 IU/mL) to Rubella at baseline |
| Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | 6 weeks Postvaccination Visit 1 or Visit 2 | Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose). |
| Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 6 weeks postvaccination | Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \<207.5 mIU/mL) to measles at baseline |
| Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.) |
| Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.) |
| Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 6 weeks postvaccination | Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.) |
| Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.) |
Participant flow
Recruitment details
18 clinical sites in the United States Date first participant visit: 08-Apr-1999 Date last participant visit: 03-Apr-2000
Participants by arm
| Arm | Count |
|---|---|
| ProQuad™ (Low Dose) One ProQuad™ (3.48 log10 plaque-forming units \[PFU\]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. | 387 |
| ProQuad™ (Middle Dose) One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. | 393 |
| ProQuad™ (High Dose) One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later. | 381 |
| M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine) One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0. | 390 |
| Total | 1,551 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 | 3 | 0 |
| Overall Study | Incomplete safety follow-up | 3 | 7 | 2 | 2 |
| Overall Study | Lost to Follow-up | 19 | 12 | 12 | 7 |
| Overall Study | Missed one or more bleeds | 13 | 10 | 6 | 7 |
| Overall Study | Protocol Violation | 2 | 3 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 13 | 16 | 12 | 3 |
Baseline characteristics
| Characteristic | Total | ProQuad™ (Low Dose) | ProQuad™ (Middle Dose) | ProQuad™ (High Dose) | M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine) |
|---|---|---|---|---|---|
| Age, Continuous | 12.9 Months STANDARD_DEVIATION 1.5 | 12.9 Months STANDARD_DEVIATION 1.5 | 12.9 Months STANDARD_DEVIATION 1.5 | 12.9 Months STANDARD_DEVIATION 1.5 | 13.0 Months STANDARD_DEVIATION 1.7 |
| Race/Ethnicity, Customized African American | 238 participants | 65 participants | 55 participants | 64 participants | 54 participants |
| Race/Ethnicity, Customized Asian/Pacific | 62 participants | 19 participants | 11 participants | 19 participants | 13 participants |
| Race/Ethnicity, Customized Caucasian | 1021 participants | 241 participants | 267 participants | 251 participants | 262 participants |
| Race/Ethnicity, Customized Hispanic | 125 participants | 34 participants | 44 participants | 22 participants | 25 participants |
| Race/Ethnicity, Customized Native American | 3 participants | 1 participants | 1 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Other | 102 participants | 27 participants | 15 participants | 24 participants | 36 participants |
| Sex: Female, Male Female | 720 Participants | 186 Participants | 181 Participants | 192 Participants | 161 Participants |
| Sex: Female, Male Male | 831 Participants | 201 Participants | 212 Participants | 189 Participants | 229 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 286 / 378 | 286 / 387 | 289 / 377 | 297 / 381 | 253 / 353 | 258 / 361 | 254 / 358 |
| serious Total, serious adverse events | 2 / 378 | 3 / 387 | 1 / 377 | 1 / 381 | 1 / 353 | 0 / 361 | 2 / 358 |
Outcome results
Primary
Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units
Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer \<1.25 gpELISA units
Time frame: 6 weeks postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to varicella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 198 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 299 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 253 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 303 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 272 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 306 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units | 298 Participants |
Secondary
Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 251.8 mcg/mL |
| ProQuad™ (Low Dose) After 2 Injections | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 549.7 mcg/mL |
| ProQuad™ (Middle Dose) After 1 Injection | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 309.5 mcg/mL |
| ProQuad™ (Middle Dose) After 2 Injections | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 783.0 mcg/mL |
| ProQuad™ (High Dose) After 1 Injection | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 315.4 mcg/mL |
| ProQuad™ (High Dose) After 2 Injections | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 747.9 mcg/mL |
| M-M-R™ II + PUVV After 1 Injection | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | 253.5 mcg/mL |
Secondary
Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 102.0 mcg/mL |
| ProQuad™ (Low Dose) After 2 Injections | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 277.7 mcg/mL |
| ProQuad™ (Middle Dose) After 1 Injection | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 106.3 mcg/mL |
| ProQuad™ (Middle Dose) After 2 Injections | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 244.1 mcg/mL |
| ProQuad™ (High Dose) After 1 Injection | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 114.7 mcg/mL |
| ProQuad™ (High Dose) After 2 Injections | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 286.0 mcg/mL |
| M-M-R™ II + PUVV After 1 Injection | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | 97.4 mcg/mL |
Secondary
Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.)
Time frame: 6 weeks postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 131.4 mcg/mL |
| ProQuad™ (Low Dose) After 2 Injections | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 263.7 mcg/mL |
| ProQuad™ (Middle Dose) After 1 Injection | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 122.5 mcg/mL |
| ProQuad™ (Middle Dose) After 2 Injections | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 230.7 mcg/mL |
| ProQuad™ (High Dose) After 1 Injection | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 115.5 mcg/mL |
| ProQuad™ (High Dose) After 2 Injections | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 254.2 mcg/mL |
| M-M-R™ II + PUVV After 1 Injection | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | 128.5 mcg/mL |
Secondary
Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT)
Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.)
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 5.7 mcg/mL |
| ProQuad™ (Low Dose) After 2 Injections | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 167.7 mcg/mL |
| ProQuad™ (Middle Dose) After 1 Injection | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 10.5 mcg/mL |
| ProQuad™ (Middle Dose) After 2 Injections | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 381.0 mcg/mL |
| ProQuad™ (High Dose) After 1 Injection | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 11.9 mcg/mL |
| ProQuad™ (High Dose) After 2 Injections | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 469.4 mcg/mL |
| M-M-R™ II + PUVV After 1 Injection | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | 16.5 mcg/mL |
Secondary
Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL
Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer \<207.5 mIU/mL) to measles at baseline
Time frame: 6 weeks postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to measles at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 321 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 311 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 338 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 327 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 321 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 326 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL | 349 Participants |
Secondary
Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL
Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer \< 2.0 Ab units/mL) to Mumps at baseline
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to mumps at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 333 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 322 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 344 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 330 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 325 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 335 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL | 350 Participants |
Secondary
Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL
Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer \<10 IU/mL) to Rubella at baseline
Time frame: 6 weeks Postvaccination
Population: The per-protocol analysis set included participants who had pre- and post-randomization blood samples within predefined day ranges, were seronegative to rubella at baseline, and followed protocol procedures.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 335 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 319 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 343 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 332 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 326 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 335 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL | 352 Participants |
Secondary
Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs)
Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose).
Time frame: 6 weeks Postvaccination Visit 1 or Visit 2
Population: All participants with follow-up for safety were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 378 Participants |
| ProQuad™ (Low Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 353 Participants |
| ProQuad™ (Low Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 1 Participants |
| ProQuad™ (Middle Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 386 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |
| ProQuad™ (Middle Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 361 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 377 Participants |
| ProQuad™ (High Dose) After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |
| ProQuad™ (High Dose) After 2 Injections | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 358 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Without Serious Vaccine-Related CAEs | 381 Participants |
| M-M-R™ II + PUVV After 1 Injection | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | With Serious Vaccine-Related CAEs | 0 Participants |