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

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.

Completed

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Key information

Conditions

Measles Chickenpox DNA Virus Infections Herpesviridae Infections Infections Mononegavirales Infections Morbillivirus Infections Mouth Diseases Mumps Paramyxoviridae Infections Parotid Diseases Parotitis RNA Virus Infections Rubella Rubivirus Infections Rubulavirus Infections Salivary Gland Diseases Stomatognathic Diseases Togaviridae Infections Varicella Varicella Zoster Virus Infection Virus Diseases

Age range

12 month–18 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

The duration of treatment is 6 weeks.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measles, Mumps, and Rubella Virus Vaccine Live

Biological

Other names: V205C

Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Biological

Primary outcomes

Antibody response rates to measles, mumps, and rubella at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Secondary outcomes

Geometric mean titers to measles, mumps, and rubella by ELISA at 6 weeks postvaccination

Time frame: 6 weeks postvaccination

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start: 2001
Primary completion: 2005
Study completion: 2005
First posted: Sep 27, 2004
Registry last updated: Mar 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed