Phase 3
N=801
A Study of ProQuad in Healthy 4 to 6 Year Old Children (V221-014)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00985166 ↗Enrolled (actual)
801
Serious AEs
0.1%
Results posted
Jan 2010
Primary outcome: Primary: Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer — 322.2; 209.3 gpELISA units/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ProQuad (Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live) (Biological); Comparator: M-M-R II (Biological); Comparator: Varivax (Biological); Comparator: Placebo (Biological)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2002
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Antibody Response to Varicella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer |
322.2; 209.3 | — |
| PRIMARY Antibody Response to Measles for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer |
1985.9; 2046.9; 2084.3 | — |
| PRIMARY Antibody Response to Mumps for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer |
206.0; 308.5; 295.9 | — |
| PRIMARY Antibody Response to Rubella for Subjects Who Had Previously Received M-M-R II + VARIVAX - Geometric Mean Titer |
217.3; 174.0; 154.1 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00985166). 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.