Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles; Mumps; Rubella; Varicella
Intervention: measles, mumps, and rubella virus vaccine live (Biological); Comparator: Measles, Mumps, and Rubella Virus Vaccine Live (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
The purpose of this trial is to study the safety and immune response to measles, mumps, and
rubella in children who were vaccinated with an investigational measles-mumps-rubella live
vaccine made with artificially made human protein.
Clinical Details
Official title: A Comparison of the Safety, Tolerability, and Immunogenicity of V205C Manufactured With Recombinant Human Albumin (rHA) Versus V205C Manufactured With Pooled-Donor Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age
Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination
Secondary outcome: Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination
Detailed description:
The duration of treatment is 6 weeks.
Eligibility
Minimum age: 12 Months.
Maximum age: 18 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Healthy children 12 to 18 months of age
Exclusion Criteria:
- History or prior exposure to measles, mumps, or rubella
- History of allergic reactions to any component of the vaccines as evaluated by the
study doctor
Locations and Contacts
Additional Information
Related publications: Wiedmann RT, Reisinger KS, Hartzel J, Malacaman E, Senders SD, Giacoletti KE, Shaw E, Kuter BJ, Schödel F, Musey LK. M-M-R(®)II manufactured using recombinant human albumin (rHA) and M-M-R(®)II manufactured using human serum albumin (HSA) exhibit similar safety and immunogenicity profiles when administered as a 2-dose regimen to healthy children. Vaccine. 2015 Apr 27;33(18):2132-40. doi: 10.1016/j.vaccine.2015.03.017. Epub 2015 Mar 18.
Starting date: December 2001
Last updated: April 29, 2015
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