Who is sponsoring NCT00644059?

NCT00644059 is sponsored by Novartis.

What condition does NCT00644059 study?

NCT00644059 studies Influenza, Human.

What drugs are being tested in NCT00644059?

Interventions: Adjuvanted trivalent inactivated subunit influenza vaccine, Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine, Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine.

What is the status of NCT00644059?

NCT00644059 is currently COMPLETED.

Last reviewed 2015-08-31 · How we verify

A Phase III, Randomized, Observer-blind, Controlled, Multi-center Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of One and Two Intramuscular Doses of Influenza Vaccine Versus Control Vaccines in Healthy Subject Aged 6 to <72 Months

NCT00644059 Phase 3 COMPLETED Results posted

This study will evaluate the efficacy, safety and immunogenicity of one or two 0.25 mL or 0.5 mL intramuscular injections of an adjuvanted influenza vaccine compared with non-influenza and non-adjuvanted influenza control vaccines in subjects 6 to \<72 months of age.

Details

Lead sponsor	Novartis
Phase	Phase 3
Status	COMPLETED
Enrolment	4902
Start date	2007-11
Completion	2010-08

Conditions

Influenza, Human

Interventions

Adjuvanted trivalent inactivated subunit influenza vaccine
Non-adjuvanted trivalent inactivated subunit influenza vaccine or non-adjuvanted trivalent inactivated split influenza vaccine
Meningococcal C conjugate vaccine or tick-borne encephalitis vaccine

Primary outcomes

Number of Subjects (Unprimed) 6 to <36 Months Age With Local and Systemic Reactions After Any Vaccination for All Seasons, Comparison of Adjuvanted Trivalent Influenza Vaccine (aTIV) and Flu Vaccine Control. — 7 days post-vaccination
Safety was assessed in terms of number of subjects experiencing each of the local and systemic reactions within 7-days after any vaccination for all seasons, comparison of adjuvanted Trivalent influenza vaccine (aTIV) and flu vaccine control.
Percentage of Subjects (Unprimed) Aged 6 to <36 Months With Virus-Confirmed Influenza, Comparison of aTIV and Non-flu Vaccine Control (Men C/TBE Vaccine) — 3 weeks after 2nd vaccination
Virus-confirmed influenza illnesses were assessed and compared between the adjuvanted influenza vaccine (TIV-adj) and non-influenza vaccines (Non-flu control) in 6 to \<36 month unprimed subjects for Absolute Efficacy. This primary endpoint is only for homologous strains.

Countries

Finland, Germany, Italy