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NCT00092404 Clinical Trial

Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)

Measles Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00092404
Other study ID # V205C-009
Secondary ID 2004_074
Status Completed
Phase Phase 2
First received September 22, 2004
Last updated March 14, 2017
Start date December 2001
Est. completion date June 2005

Study information
Verified date March 2017
Source Merck Sharp & Dohme Corp.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Description:

The duration of treatment is 6 weeks.

Recruitment information / eligibility
Status Completed
Enrollment 1210
Est. completion date June 2005
Est. primary completion date June 2005
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 18 Months
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• measles, mumps, and rubella virus vaccine live

• Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination 6 weeks postvaccination
Secondary Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination 6 weeks postvaccination
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