Clinical Study to Evaluate the Safety, Immunogenicity and Efficacy of Investigational Flu Vaccine Compared to Approved Flu Vaccine in Children.

Completed · Phase 3

Conditions studied: Influenza Virus

In brief

Safety, Immunogenicity and Efficacy of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children ≥6 to \<72 Months of Age. The study was conducted during the 2013/2014 and 2014/2015 northern hemisphere influenza season.

Key facts

Study ID

NCT01964989

Run by

Seqirus

People needed

10644

Starts

2013-11-01

Expected to finish

2016-08-01

Last updated by the study team

2023-03-27

Who can join

Age: 1 and older, up to 6. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Children, males and females, healthy or at high risk of complications from influenza, between ≥6 months to <72 months of age
• Documented consent provided by the subject's parent(s)/legal guardian(s)
• Subjects and/or subject's parent(s)/legal guardian(s) able to comply with all study procedures.

You may not qualify if…

• Children with history of allergy to vaccine components.
• Additional eligibility criteria may be discussed by contacting the site

Where it is running

• 267, Novartis Investigational Site — Harrisburg, Arkansas, United States
• 259, Novartis Investigational Site — Anaheim, California, United States
• 280, Novartis Investigational Site — Anaheim, California, United States
• 213, Novartis Investigational Site — Baldwin Park, California, United States
• 407, Novartis Investigational Site — Downey, California, United States
• 238, Novartis Investigational Site — La Puente, California, United States
• 411, Novartis Investigational Site — Ontario, California, United States
• 202, Novartis Investigational Site — Paramount, California, United States
• 250, Novartis Investigational Site — San Diego, California, United States
• 293, Novartis Investigational Site — San Francisco, California, United States
• 243, Novartis Investigational Site — Colorado Springs, Colorado, United States
• 249, Novartis Investigational Site — Denver, Colorado, United States
• 229, Novartis Investigational Site — Boca Raton, Florida, United States
• 416, Novartis Investigational Site — Hialeah, Florida, United States
• 287, Novartis Investigational Site — Hialeah, Florida, United States
• 412, Novartis Investigational Site — Homestead, Florida, United States
• 224, Novartis Investigational Site — Melbourne, Florida, United States
• 417, Novartis Investigational Site — Miami, Florida, United States
• 404, Novartis Investigational Site — Miami, Florida, United States
• 285, Novartis Investigational Site — Miami, Florida, United States
• 277,Novartis Investigational Site — Miami, Florida, United States
• 234, Novartis Investigational Site — Opa-locka, Florida, United States
• 297, Novartis Investigational Site — Orlando, Florida, United States
• 297, Novartis Investigational vaccine — Orlando, Florida, United States
• 222, Novartis Investigational Site — Chandler, Arizona, United States

Full record on ClinicalTrials.gov

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