Phase 3
N=1,412
Safety, Tolerability, and Immunogenicity of Measles, Mumps, Rubella, and Varicella (MMRV) Vaccine Made With an Alternative Manufacturing Process (AMP)(V221-027)
Measles · Mumps · Rubella · Varicella
Bottom Line
View on ClinicalTrials.gov: NCT01536405 ↗Enrolled (actual)
1,412
Serious AEs
2.9%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL — 97.3; 93.0 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MMRV (AMP) (Biological); MMRV (2006 process) (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Varicella Zoster Virus (VZV) Antibody Levels >=5 gpELISA Units/mL |
97.3; 93.0 | <0.001 sig |
| PRIMARY Percentage of Participants With Measles Virus Antibody Levels >=255 mIU/mL |
96.7; 98.9 | 0.003 sig |
| PRIMARY Percentage of Participants With Mumps Virus Antibody Levels >=10 Units/mL |
98.2; 97.2 | <0.001 sig |
| PRIMARY Percentage of Participants With Rubella Virus Antibody Levels >=10 International Units/mL (IU/mL) |
98.8; 99.3 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of VZV Antibodies |
17.3; 14.4 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of Measles Virus Antibodies |
3426.5; 3719.5 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of Mumps Virus Antibodies |
112.1; 114.0 | <0.001 sig |
| PRIMARY Geometric Mean Titer (GMT) of Rubella Virus Antibodies |
81.8; 80.7 | <0.001 sig |
| PRIMARY Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) |
10.0; 10.6; 5.7; 8.4 | — |
| SECONDARY Percentage of Participants With Fever (>=102.2°F [39.0°C] or Oral Equivalent) |
10.0; 10.6; 5.7; 8.4 | — |
| SECONDARY Percentage of Participants With Zoster-like Rash |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Mumps-like Symptoms |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Measles-like Rash |
0.1; 0.3; 0.2; 0.0 | — |
| SECONDARY Percentage of Participants With Rubella-like Rash |
0.0; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With Varicella-like Rash |
0.6; 0.0; 0.0; 0.0 | — |
| SECONDARY Percentage of Participants With an Injection-site Adverse Event |
36.4; 29.8; 35.5; 29.6 | — |
Summary
This study will compare the safety, tolerability, and immunogenicity of measles, mumps, rubella, and varicella (MMRV) vaccine made with an alternative manufacturing process with those of the 2006 process
Eligibility Criteria
Inclusion Criteria
- Negative clinical history for measles, mumps, rubella, varicella, and zoster
Exclusion Criteria
- Received any measles, mumps, rubella, or varicella vaccine, either alone or in any combination at any time prior to the study, or is anticipated to receive any of these vaccines outside of study protocol, either alone or in any combination, during the study
- Received immune globulin, a blood transfusion or blood-derived products (does not include autologous blood/blood products) within 5 months (150 days) prior to any dose of the study vaccines or plans to receive these products while enrolled in this study
- Exposed to measles, mumps, rubella, varicella, or zoster within 4 weeks prior to the study vaccination
- Any congenital or acquired immune deficiency, neoplastic disease, or depressed immunity, including that resulting from steroid use or other immunosuppressive therapy
- Received 1) systemic immunomodulatory steroids [greater than the
equivalent of 2 mg/kg total daily dose of prednisone] within 3 months prior to
entering the study, or 2) any dose of systemic immunomodulatory steroids within
7 days prior to entering study, or 3) is expected to require systemic immunomodulatory steroids through the course of the study
- History of allergy or anaphylactoid reaction to gelatin, sorbitol, neomycin, egg proteins (eggs or egg products), chicken proteins, or any component of the study vaccines
- Received salicylates (eg, aspirin or aspirin-containing products) within 14 days prior to study vaccination
- Diagnosis of an active neurological disorder. Enrollment may be considered
when the disease process has been stabilized
- History of seizure disorder, including single febrile seizure
- Diagnosis of active untreated tuberculosis
- History of thrombocytopenia
- Born to a human immunodeficiency virus (HIV) infected mother
Data sourced from ClinicalTrials.gov (NCT01536405). 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.