Measles, Mumps, Rubella, Varicella
Conditions
Brief summary
The study was conducted to determine if ProQuad may be used in place of the second dose of M-M-R II routinely given to children 4 to 6 years old who were previously immunized with M-M-R II and Varivax.
Interventions
BIOLOGICALProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live)
A Single 0.5 mL subcutaneous injection at Day 1
BIOLOGICALComparator: M-M-R II
A Single 0.5 mL subcutaneous injection at Day 1
BIOLOGICALComparator: Varivax
A Single 0.5 mL subcutaneous injection at Day 1
BIOLOGICALComparator: Placebo
A Single 0.5 mL subcutaneous placebo injection at Day 1
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* In good health * Received primary dose of M-M-R II at less than or equal to 12 months of age * Received primary dose of Varivax at less than or equal to 12 months of age * Negative history of varicella, zoster, measles, mumps, and rubella
Exclusion criteria
* history of receiving more than once dose of M-M-R II or Varivax * 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 * Receipt of immune globulin, or blood product in the past 5 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer of antibody to Varicella |
| Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer of antibody to Measles |
| Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer of antibody to Mumps |
| Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 6 weeks Postvaccination | Postvaccination observed Geometric Mean Titer of antibody to Rubella |
Participant flow
Recruitment details
17 clinical sites in the United States Date of first participant visit: 24-Aug-2000 Date of last participant visit: 06-May-2002
Pre-assignment details
Prior to entering study, all subjects received primary dose of M-M-R II™ and Varivax™ at less than or equal to 12 months of age.
Participants by arm
| Arm | Count |
|---|---|
| ProQuad™ + Placebo ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1. | 399 |
| M-M-R™ II + Placebo M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1. | 205 |
| M-M-R™ II + VARIVAX™ VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1. | 195 |
| Total | 799 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 2 | 2 |
| Overall Study | Other | 1 | 0 | 1 |
| Overall Study | Test not done | 2 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 3 | 2 | 0 |
Baseline characteristics
| Characteristic | ProQuad™ + Placebo | M-M-R™ II + Placebo | M-M-R™ II + VARIVAX™ | Total |
|---|---|---|---|---|
| Age, Continuous | 4.3 years STANDARD_DEVIATION 0.5 | 4.3 years STANDARD_DEVIATION 0.5 | 4.3 years STANDARD_DEVIATION 0.5 | 4.3 years STANDARD_DEVIATION 0.5 |
| Race/Ethnicity, Customized African American | 49 participants | 19 participants | 25 participants | 93 participants |
| Race/Ethnicity, Customized Asian/Pacific | 8 participants | 5 participants | 3 participants | 16 participants |
| Race/Ethnicity, Customized Caucasian | 313 participants | 162 participants | 153 participants | 628 participants |
| Race/Ethnicity, Customized Hispanic | 15 participants | 10 participants | 7 participants | 32 participants |
| Race/Ethnicity, Customized Other | 14 participants | 9 participants | 7 participants | 30 participants |
| Sex: Female, Male Female | 191 Participants | 105 Participants | 77 Participants | 373 Participants |
| Sex: Female, Male Male | 208 Participants | 100 Participants | 118 Participants | 426 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 | 292 / 397 | 150 / 205 | 140 / 193 |
| serious Total, serious adverse events | 1 / 397 | 0 / 205 | 0 / 193 |
Outcome results
Primary
Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Measles
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ + Placebo | Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 1985.9 mIU/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 2046.9 mIU/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 2084.3 mIU/mL |
Primary
Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Mumps
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ + Placebo | Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 206.0 ELISA AB units/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 308.5 ELISA AB units/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 295.9 ELISA AB units/mL |
Primary
Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Rubella
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ + Placebo | Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 217.3 IU/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 174.0 IU/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 154.1 IU/mL |
Primary
Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer
Postvaccination observed Geometric Mean Titer of antibody to Varicella
Time frame: 6 weeks Postvaccination
Population: Per-protocol analysis set includes participants who had pre- and postvaccination blood samples within predefined day ranges, received M-M-R™ II + VARIVAX™ prior to entering the study, and followed protocol procedures.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ProQuad™ + Placebo | Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 322.2 gpELISA units/mL |
| M-M-R™ II + VARIVAX™ | Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer | 209.3 gpELISA units/mL |