Phase 3
N=3,927
Safety, Tolerability, and Immunogenicity of 3 Frozen ProQuad Consistency Lots in Healthy Children (V221-012)(COMPLETED)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00985153 ↗Enrolled (actual)
3,927
Serious AEs
0.9%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL — 726; 718; 736; 772 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological); Comparator: Varivax (Biological); Comparator: M-M-R II (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2001
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postvaccination Varicella Antibody Titer ≥ 5 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL |
726; 718; 736; 772 | — |
| PRIMARY Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 120 mIU/mL |
790; 753; 753; 800 | — |
| PRIMARY Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 10 Ab Units/mL |
825; 796; 788; 854 | — |
| PRIMARY Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL |
852; 821; 828; 859 | — |
| PRIMARY Antibody Response to Varicella for Subjects Initially With Varicella Antibody Titer < 1.25 gpELISA Units/mL at Baseline - Geometric Mean Titer |
16.0; 18.4; 19.7; 17.6 | — |
| PRIMARY Antibody Response to Measles for Subjects Initially Seronegative (a Titer < 120 mIU/mL) to Measles at Baseline - Geometric Mean Titer |
3031.6; 2939.3; 2852.2; 2095.6 | — |
| PRIMARY Antibody Response to Mumps for Subjects Initially Seronegative (a Titer < 10 Ab Units/mL) to Mumps at Baseline - Geometric Mean Titer |
100.5; 102.3; 85.6; 89.7 | — |
| PRIMARY Antibody Response to Rubella for Subjects Initially Seronegative (a Titer < 10 IU/mL) to Rubella at Baseline - Geometric Mean Titer |
113.5; 114.8; 114.2; 132.6 | — |
| PRIMARY Number of Participants With Serious Vaccine-related CAEs |
2; 1; 2; 1; 967; 949 | — |
Summary
This study will compare three consistency lots of ProQuad to each other as well as to M-M-R II and Varivax, administered concomitantly at different injection sites, with respect to immunogenicity, safety, and tolerability.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00985153). 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.