Measles Clinical Trial
Official title:
A Dose Selection Study in Healthy Children Comparing Measles Mumps, Rubella, and Varicella (ProQuad) Vaccine to M-M-R II Given Concomitantly With Process Upgrade Varicella Vaccine (PUVV) in Separate Injections
Verified date | March 2015 |
Source | Merck Sharp & Dohme Corp. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
A Study comparing three different doses of ProQuad to concomitant administration of M-M-R II and PUVV (Process Upgrade Varicella Vaccine) vaccines.
Status | Completed |
Enrollment | 1551 |
Est. completion date | September 2000 |
Est. primary completion date | April 2000 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 12 Months to 23 Months |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Merck Sharp & Dohme Corp. |
Shinefield H, Black S, Williams WR, Marchant C, Reisinger K, Stewart T, Meissner HC, Guerrero J, Klopfer SO, Xu J, Schödel F, Kuter BJ; Dose Selection Study Group for Proquad. Dose-response study of a quadrivalent measles, mumps, rubella and varicella vac — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants With Varicella Glycoprotein Enzyme-Linked Immunosorbent Assay (gpELISA) Antibody Titer = 5 gpELISA Units | Antibody response to Varicella at 6 weeks postvaccination in participants with baseline titer <1.25 gpELISA units | 6 weeks postvaccination | No |
Secondary | Number of Participants With Postvaccination Measles Enzyme-Linked Immunosorbent Assay (ELISA) Antibody Titer = 207.5 mIU/mL | Antibody response to measles at 6 weeks postvaccination in participants initially seronegative (a titer <207.5 mIU/mL) to measles at baseline | 6 weeks postvaccination | No |
Secondary | Number of Participants With Postvaccination Mumps ELISA Antibody Titer = 2.0 Ab Units/mL | Antibody response to Mumps at 6 weeks postvaccination in participants initially seronegative (a titer < 2.0 Ab units/mL) to Mumps at baseline | 6 weeks Postvaccination | No |
Secondary | Number of Participants With Postvaccination Rubella ELISA Antibody Titer = 10 IU/mL | Antibody response to Rubella at 6 weeks postvaccination in participants initially seronegative (a titer <10 IU/mL) to Rubella at baseline | 6 weeks Postvaccination | No |
Secondary | Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences (CAEs) | Participants with a serious vaccine-related CAE (an AE which is assessed by an investigator/qualified physician as being related to study vaccine and results in death, persistent or significant disability/incapacity, prolongs an existing inpatient hospitalization, is life-threatening, a congenital anomaly/birth defect, a cancer, or an overdose). | 6 weeks Postvaccination Visit 1 or Visit 2 | Yes |
Secondary | Antibody Response to Varicella at 6 Weeks Postvaccination in Participants With Baseline Titer < 1.25 gpELISA Units - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Varicella antibody. (Titers measured using Varicella zoster virus (VZV) gpELISA.) | 6 weeks Postvaccination | No |
Secondary | Antibody Response to Measles at 6 Weeks Postvaccination in Participants Initially Seronegative to Measles at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Measles antibody. (Titers measured using Measles ELISA.) | 6 weeks Postvaccination | No |
Secondary | Antibody Response to Mumps at 6 Weeks Postvaccination in Participants Initially Seronegative to Mumps at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Mumps antibody. (Titer measured using Mumps ELISA.) | 6 weeks Postvaccination | No |
Secondary | Antibody Response to Rubella at 6 Weeks Postvaccination in Participants Initially Seronegative to Rubella at Baseline - Geometric Mean Titer (GMT) | Postvaccination observed Geometric Mean Titer (GMT) of Rubella antibody. (Titers measured using Rubella ELISA.) | 6 weeks postvaccination | No |
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