Phase 3
N=1,027
V221 Concomitant Use Study With Pneumococcal Conjugate Vaccine (V221-019)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT00109343 ↗Enrolled (actual)
1,027
Serious AEs
0.4%
Results posted
Feb 2010
Primary outcome: Primary: Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL — 395; 203 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Comparator: ProQuad™ (V221) (Biological); Comparator: PREVNAR™ (pneumococcal 7-valent conjugate vaccine) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Sep 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer ≥255 mIU/mL |
395; 203 | — |
| PRIMARY Number of Participants With Postvaccination Mumps ELISA Antibody Titer ≥10 Ab Units/mL |
390; 205 | — |
| PRIMARY Number of Participants With Postvaccination Rubella ELISA Antibody Titer ≥10 IU/mL |
372; 191 | — |
| PRIMARY Number of Participants With Postvaccination Varicella Antibody Titer ≥1.25 Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Units/mL and ≥5 gpELISA Units/mL |
374; 187; 350; 169 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 4 - Geometric Mean Titer |
1.54; 1.34 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 6B - Geometric Mean Titer |
9.17; 8.22 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 9V - Geometric Mean Titer |
2.98; 2.71 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 14 - Geometric Mean Titer |
6.88; 5.61 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 18C - Geometric Mean Titer |
2.35; 2.23 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 19F - Geometric Mean Titer |
3.59; 3.22 | — |
| PRIMARY Antibody Response to S. Pneumoniae Serotype 23F - Geometric Mean Titer |
4.24; 3.71 | — |
Summary
The study is being conducted to demonstrate that V221 may be administered concomitantly with pneumococcal conjugate vaccine without impairing the safety or immunogenicity of measles, mumps, rubella, varicella, or the 7 serotypes of S. pneumoniae.
Eligibility Criteria
Inclusion Criteria
- In good health
- 12 to 15 months of age
- Negative clinical history to measles, mumps, rubella, varicella and/or zoster
- Received only the 3-dose primary series of a pneumococcal conjugate vaccine with at least 2 months prior to the receipt of any of the study vaccines
- Signed consent
Exclusion Criteria
- Previous administration of any measles, mumps, rubella, or varicella vaccine either alone or in any combination
- Any condition resulting in depressed immunity
- Any allergy to any vaccine component as stated in the package circulars
- Exposure to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
- History of seizure disorder
- Receipt of an inactivated vaccine within 14 days prior to enrollment or live vaccine within 30 days
- Recent febrile illness
Data sourced from ClinicalTrials.gov (NCT00109343). 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.