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Completed

NCT Number: NCT00109278

A Measles, Mumps, and Rubella Investigational Vaccine Trial (V205C-010)(COMPLETED)

The purpose of this study is to test the safety of a measles, mumps, and rubella study vaccine made from a new measles stock seed (a component of the vaccine made in 2003) with rHA (recombinant human albumin).

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Key information

Conditions

Measles Infections Mononegavirales Infections Morbillivirus Infections Paramyxoviridae Infections RNA Virus Infections 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

  • Previous receipt of measles, mumps, rubella and/or varicella vaccine.
  • Prior infection or exposure to (within last 4 weeks) measles, mumps, rubella, varicella and/or zoster.
  • Any medical condition that might interfere with the immune response to the given vaccines (including HIV infection and/or cancer) or has undergone immunosuppressive (weakens your body's ability to fight infection) therapy.
  • History of seizures (convulsions)
  • Allergies to any component of the vaccine, including sorbitol, gelatin, or neomycin.
  • A recent (within the last 3 days) illness resulting in a fever (underarm temperature greater than 99.5° F [37.5° C]).

Treatment and study plan

V205C, measles, mumps, and rubella virus vaccine live

Biological

Comparator: Measles, Mumps, and Rubella Virus Vaccine Live

Biological

Primary outcomes

  1. Antibody response rate to measles at 6 weeks postvaccination

Secondary outcomes

  1. Geometric mean titers to measles by ELISA at 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 From the 2003 Measles Stock Seed With Recombinant Human Albumin (rHA) Versus Currently Licensed V205C Manufactured From the 1967 Measles Stock Seed With Human Serum Albumin (HSA) in Healthy Children 12 to 18 Months of Age

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Apr 26, 2005
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.

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