Last updated on November 2017

A New Clinical Research Study Comparing a Half and Full Dose of Influenza Vaccine in Healthy Children

Brief description of study

A New Clinical Research Study Comparing a Half and Full Dose of Influenza Vaccine in Healthy Children

Detailed Study Description

Your child can be part of an important clinical study of influenza vaccine.

You probably know how important vaccinations are in helping to prevent infectious diseases. By participating in this research study, your child can play an important role in helping researchers learn about other ways we might be able to help protect against influenza (the flu).

What is the purpose of the study?

The purpose of this study is to see if an investigational full dose (0.5-mL) of a certain influenza vaccine is as safe and offers as much protection against the flu virus as a half dose (0.25-mL) in children 6 through 35 months of age. The half dose (0.25-mL) of the vaccine being studied is already approved by the US Food and Drug Administration (FDA) for use in children 6 through 35 months of age, while the investigational full dose (0.5-mL) is approved only for use in children 3 years of age and older.

What is influenza (the flu)?

Influenza, or the flu, is an infection of the nose, throat, and lungs that is caused by influenza virus. The flu is contagious and usually spreads from person to person when virus-containing droplets travel through the air after someone with the flu sneezes or coughs. The symptoms of the flu, which include fever, cough, sore throat, body aches, and weakness, can last from several days to a week or more.

How is influenza (the flu) prevented?

Getting a flu vaccine yearly is the best way to help prevent the flu or at least lessen its severity. Because the viruses that cause the flu usually change each season, the flu vaccine usually changes from year to year, too. This is one reason why we need to get vaccinated against the flu every year.

Clinical Study Identifier: TX145797


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