Phase 2
N=1,551
ProQuad Dose Selection Study (V221-011)(COMPLETED)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00986232 ↗Enrolled (actual)
1,551
Serious AEs
0.4%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units — 198; 299; 253; 303 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (Biological); Comparator: M-M-R II (Biological); Comparator: PUVV (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Apr 2000
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer ≥ 5 gpELISA Units |
198; 299; 253; 303; 272; 306 | — |
| SECONDARY Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥ 207.5 mIU/mL |
321; 311; 338; 327; 321; 326 | — |
| SECONDARY Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥ 2.0 Ab Units/mL |
333; 322; 344; 330; 325; 335 | — |
| SECONDARY Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥ 10 IU/mL |
335; 319; 343; 332; 326; 335 | — |
| SECONDARY Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) |
5.7; 167.7; 10.5; 381.0; 11.9; 469.4 | — |
| SECONDARY Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) |
251.8; 549.7; 309.5; 783.0; 315.4; 747.9 | — |
| SECONDARY Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) |
102.0; 277.7; 106.3; 244.1; 114.7; 286.0 | — |
| SECONDARY Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) |
131.4; 263.7; 122.5; 230.7; 115.5; 254.2 | — |
Summary
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
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
- Immune globulin or any blood product administered in the past 3 months
Data sourced from ClinicalTrials.gov (NCT00986232). 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.