Phase 3
N=480
ProQuad™ Versus M-M-R II™ and VARIVAX™ in Healthy Children (V221-009)(COMPLETED)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00975507 ↗Enrolled (actual)
480
Serious AEs
0.3%
Results posted
Feb 2010
Primary outcome: 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 — 228; 237; 118 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological); Comparator: Placebo (Biological); Comparator: Varivax (Biological); Comparator: M-M-R II (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jan 1999
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
228; 237; 118 | — |
| SECONDARY Number of Participants With Postvaccination Measles ELISA Antibody Titer ≥207.8 mIU/mL |
290; 284; 145 | — |
| 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 |
264; 275; 134 | — |
| SECONDARY Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥2.0 Ab Units/mL |
292; 283; 148 | — |
| SECONDARY Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL |
289; 275; 142 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00975507). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.