Pediatric Safety and Immunogenicity Study of Cell-Culture Derived and Egg-based Subunit Influenza Vaccines in Healthy Children and Adolescents

Completed · Phase 2/Phase 3

Conditions studied: Influenza

In brief

The present study is the first study designed to evaluate safety, tolerability and immunogenicity of the cell culture-derived influenza vaccine in healthy children and adolescents aged 3 to 17 years. A step-down approach is utilized in which reactogenicity and safety will be assessed in children and adolescents 9 to 17 years of age (Cohort 1) prior to enrolling additional children and adolescents 9 to 17 years of age (Cohort 2) and children 3 to 8 years of age (Cohort 3).

Key facts

Study ID

NCT00645411

Run by

Novartis

People needed

3604

Starts

2007-10-01

Expected to finish

2008-07-01

Last updated by the study team

2015-11-23

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects aged 9 to 17 years (Cohorts 1 and 2) and 3 to 8 years (Cohort 3), whose parents/legal guardians have given written informed consent prior to study entry. Assent will be obtained from subjects according to age requirements of the ECs/IRBs;
• In good health as determined by:
• medical history,
• physical examination,
• clinical judgment of the Investigator;
• Able to comply with all study procedures and available for all clinic visits and telephone calls scheduled in the study.

You may not qualify if…

• Any serious disease, such as:
• cancer,
• autoimmune disease (including rheumatoid arthritis),
• diabetes mellitus,
• chronic pulmonary disease,
• acute or progressive hepatic disease,
• acute or progressive renal disease;
• History of any anaphylaxis or serious reaction following administration of vaccine, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials;
• Known or suspected impairment/alteration of immune function, including:
• use of immunosuppressive therapy such as systemic corticosteroids known to be associated with the suppression of hypothalamic-pituitary-adrenal (HPA) axis or chronic use of inhaled high-potency corticosteroids within 60 days prior to Visit 1,
• cancer chemotherapy,
• receipt of immunostimulants within 60 days prior to Visit 1,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
• known HIV infection or HIV-related disease;
• History of Guillain-Barré syndrome;
• Bleeding diathesis;
• Surgery planned during the study period;
• Receipt of another investigational agent within 90 days, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
• Receipt of another vaccine within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to Visit 1;
• Laboratory-confirmed influenza disease within 6 months prior to Visit 1;
• For subjects aged 3 to 8 years old, ever received two doses of an influenza vaccine in one influenza season;
• Receipt of an influenza vaccine within 6 months prior to Visit 1;
• Experienced a temperature 38.0°C [100.4°F]) and/or any acute illness within 3 days prior to Visit 1;
• Pregnant or nursing mother;
• Female of childbearing potential who is sexually active and has not used acceptable birth control measures for at least 2 months prior to study entry and who does not plan to use acceptable birth control measures during the 3 weeks following vaccination or refuses to have a urine pregnancy test prior to enrollment. Oral, injected, inserted or implanted hormonal contraceptive, diaphragm or condom with spermicidal agent or intrauterine device are considered acceptable forms of birth control;

Where it is running

• Site 10 — Downey, California, United States
• Site 02 — Bardstown, Kentucky, United States
• Site 14 — Metairie, Louisiana, United States
• Site 01 — St Louis, Missouri, United States
• Site 11 — Omaha, Nebraska, United States
• Site 04 — Edison, New Jersey, United States
• Site 05 — Endwell, New York, United States
• Site 16 — Fort Worth, Texas, United States
• Site 13 — San Angelo, Texas, United States
• Site 12 — San Antonio, Texas, United States
• Site 08 — Bountiful, Utah, United States
• Site 07 — Salt Lake City, Utah, United States
• Site 03 — Salt Lake City, Utah, United States
• Site 06 — Burke, Virginia, United States
• Site 15 — Spokane, Washington, United States
• Site 27:Institute of Public Health — Zagreb, City of Zagreb, Croatia
• Site 29: Institute of Public Health — Zagreb, City of Zagreb, Croatia
• Site 40:Spec. Pediatric Dispensary — Zagreb, City of Zagreb, Croatia
• Site 49: Spec. Pediatric Dispensary — Zagreb, City of Zagreb, Croatia
• Site 50: Spec. Pediatric Dispensary — Zagreb, City of Zagreb, Croatia
• Site 86: Spec. Pediatric Dispensary — Zagreb, City of Zagreb, Croatia
• Site 44:Spec. Pediatric Dispensary — Đakovo, Dakovo, Croatia
• Site 43: Spec. Pediatric Dispensary — Sisak, Sisak, Croatia
• Site 83 — Ljudevita Gaja 2, Djakovo, Croatia
• Site 09 — Fayetteville, Arkansas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.