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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

Page last updated: August 23, 2015

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