Influenza, Human

A Study to Evaluate the Immunogenicity and Safety of Seqirus Quadrivalent Influenza Vaccine (QIV) in a Pediatric Population 6 Months Through 59 Months of Age.

NCT02914275 | PHASE 3 | INTERVENTIONAL

This is a study to assess the immune (antibody) response and safety of a Seqirus split virion, inactivated Quadrivalent Influenza Vaccine (Seqirus QIV), in comparison with a US licensed 2016/2017 Quadrivalent Influenza Vaccine (comparator QIV) in a healthy pediatric population 6 months through 59 months of age.

39 Sites

2250 Participants

Recruiting

6 Months to 59 Months

If interested, contact clinicaltrials@cslbehring.com for more information

CSL Behring respects your privacy. For an explanation of how CSL Behring will use the information you are submitting, please view our Privacy Policy

Find closest sites:

SUBMIT

Site

Birmingham,Alabama,United States,35205

Site

Mobile,Alabama,United States,36608

Site

Anaheim,California,United States,92804

Site

Anaheim,California,United States,92804

Site

Downey,California,United States,90241

Site

Ontario,California,United States,91762

Site

Paramount,California,United States,90723

Site

Sacramento,California,United States,95822

Site

San Diego,California,United States,92103

Site

Miami,Florida,United States,33175

Site

Miami,Florida,United States,33176

Site

Meridian,Idaho,United States,83642

Site

Augusta,Kansas,United States,67010

Site

Newton,Kansas,United States,67114

Site

Wichita,Kansas,United States,67205

Site

Louisville,Kentucky,United States,40202

Site

Louisville,Kentucky,United States,40291

Site

Louisville,Kentucky,United States,40291

Site

Metairie,Louisiana,United States,70002

Site

Metairie,Louisiana,United States,70006

Site

Binghamton,New York,United States,13901

Site

Asheboro,North Carolina,United States,27203

Site

Cincinnati,Ohio,United States,45229

Site

Dayton,Ohio,United States,45419

Site

Charleston,South Carolina,United States,29407

Site

Spartanburg,South Carolina,United States,29303

Site

Bristol,Tennessee,United States,37620

Site

Kingsport,Tennessee,United States,37660

Site

Austin,Texas,United States,78705

Site

Fort Worth,Texas,United States,76135

Site

San Angelo,Texas,United States,76904

Site

Layton,Utah,United States,84041

Site

Salt Lake City,Utah,United States,84109

Site

Salt Lake City,Utah,United States,84121

Site

Salt Lake City,Utah,United States,84124

Site

West Jordan,Utah,United States,84084

Site

West Jordan,Utah,United States,84088

Site

West Jordan,Utah,United States,84088

Site

Charlottesville,Virginia,United States,22902

Study Eligibility Criteria

Inclusion Criteria

* Male or female subject 6 months through to 59 months of age at the time of first vaccination and born between 36 and 42 weeks of gestation;
* Parent or legally acceptable representative able to provide written informed consent and be willing and able to adhere to all protocol requirements including blood draws.
* Subject is in generally good health as per the Investigator's medical judgment

Exclusion Criteria

* History of allergic reactions to egg proteins or any components of the Study Vaccines;
* History of serious adverse reactions to any influenza vaccines;
* History of Guillain-Barré syndrome or other demyelinating disease such as encephalomyelitis and transverse myelitis;
* History of licensed or investigational influenza vaccination in the last 6 months;
* Clinical signs of active infection and/or an axillary temperature of ≥ 99.5°F / (≥ 37.5 °C) on the day of vaccination or within 48 hours preceding vaccination.
* Current or recent, acute or chronic medical conditions that in the opinion of the Investigator are clinically significant and/or unstable
* History of any seizures, with the exception of a single febrile seizure;
* Self-reported or known seropositivity suggestive of acute or chronic viral infection for human immunodeficiency virus, hepatitis B or hepatitis C;
* Known or suspected congenital or acquired immunosuppressive conditions;
* Current or recent immunosuppressive or immunomodulatory therapy
* Current or medical history of malignant neoplasms;
* Administration of immunoglobulin and/or any blood products within the previous 90 days preceding the administration of the Study Vaccine or planned administration during the study;
* Participation in a clinical trial or use of an investigational compound within 28 days prior to or 28 days after receiving the Study Vaccine, or plans to enter a study during this period;
* Vaccination with a licensed vaccine 21 days (for live or inactivated vaccines) prior to receiving the Study Vaccine, or plans to receive any licensed vaccine prior to the Study Exit Visit.
* Medical conditions or treatment contraindicating intramuscular vaccination due to increased risk of bleeding.
* Family members of the employees of the Investigator or study center with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study center.

Additional Studies

Additional studies can be found at ClinicalTrials.gov