Safety, Tolerability, and Immunogenicity of an Investigational Vaccine With Recombinant Human Albumin (rHA) in Children 12 to 18 Months of Age (V205C-009)(COMPLETED)
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
2 other identifiers
interventional
1,210
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2001
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2001
CompletedFirst Submitted
Initial submission to the registry
September 22, 2004
CompletedFirst Posted
Study publicly available on registry
September 27, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2005
CompletedMarch 15, 2017
March 1, 2017
3.5 years
September 22, 2004
March 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination
6 weeks postvaccination
Secondary Outcomes (1)
Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination
6 weeks postvaccination
Interventions
Eligibility Criteria
You may qualify if:
- Healthy children 12 to 18 months of age
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Wiedmann RT, Reisinger KS, Hartzel J, Malacaman E, Senders SD, Giacoletti KE, Shaw E, Kuter BJ, Schodel F, Musey LK. M-M-R((R))II manufactured using recombinant human albumin (rHA) and M-M-R((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.
PMID: 25796337BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2004
First Posted
September 27, 2004
Study Start
December 1, 2001
Primary Completion
June 1, 2005
Study Completion
June 1, 2005
Last Updated
March 15, 2017
Record last verified: 2017-03