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Therapeutic Areas: Immunology | Pediatrics/Neonatology | Vaccines
Disease Category: Vaccines
Location: United States, UT

Clinical Trial Details

Overview

Research Study Summary

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

Purpose

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.

To Learn more

CW ID: 219883
Date Last Changed: October 24, 2016

Clinical Trial Snapshot

Phase
4
Gender
Both Male and Female
Age
6 to 36 Months
Overall Status
Recruiting
Lead Sponsor
Sanofi Pasteur, a Sanofi Company
Facility Type
Out-Patient

Eligibility

What will happen if I enroll my child?

By enrolling your child in this study, he or she will receive influenza study vaccine either as a half dose (0.25-mL) or a full dose (0.5-mL). Your child may receive 1 or 2 doses of study vaccine, based on recommendations that take into account your child’s history of flu vaccination. The study doctor will be able to explain the study in more details.

What are the requirements?

In order to be considered for this study, your child must be, at a minimum:

  • At least 6 months of age but younger than 3 years of age at the time of vaccination
  • In good health and not have any condition (past or present) that would pose a health risk to him or her, or interfere with the evaluation of the vaccine

Please be aware that there are other requirements that your child will need to meet in order to participate.

More Info

How do I enroll my child?

Ask the study doctor about participating. He or she will be able to go over the study details with you and determine whether your child meets all the requirements necessary to enroll in the study.

Contact

Olga Mayurova, Recruitment Manager
Advanced Clinical Research, UT
3590 West 9000 South Suite 300
Salt Lake City, UT 84088
Phone: 801-542-8198
Fax: 801-542-8190

View Map

Research Center Information:

Advanced Clinical Research, UT

Volunteer for this Trial

If you would like to learn more about participating in this research study, please email the trial contact using the form below. We value your privacy and your information will only be used by the research center to contact you regarding this study.

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