A Phase II, Observer-Blind, Randomized, Parallel Groups, Single Center, Exploratory Clinical Study to Evaluate the Immunogenicity and Safety of One and Two 0.25 mL Intramuscular Doses of FLUAD™ versus Two 0.25mL Intramuscular Doses of Vaxigrip™ Influenza Vaccines in Healthy Subjects Aged 6 to <36 Months - n/a

Conditions: Influenza (vaccine trial)
MedDRA version: 8.1Level: PTClassification code 10022000Term: Influenza

Registration Number: EUCTR2006-003181-34-FI

Lead Sponsor: ovartis Vaccines and Diagnostics S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

1) Healthy children of 6 months to 36 months of age, whose parents have given written informed consent prior to the study entry, and in good health as determined by:
a. medical history,
b. physical examination,
c. clinical judgment of the investigator.

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Experience of a severe acute infectious disease in the month prior to study start or experience of a mild acute infection disease in the week prior the study start (untreated common cold is acceptable).
2) Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 30 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
3) Fever within the 7 days before enrollment
4) Any serious disease including, for example:
a. cancer,
b. autoimmune disease (including rheumatoid arthritis),
c. diabetes mellitus,
d. chronic pulmonary disease,
e. acute or progressive hepatic disease,
f. acute or progressive renal disease
5) Known or suspected impairment/alteration of immune function, for example, resulting from:
a. receipt of immunosuppressive
b. receipt of immunostimulants,
c. receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within the past 3 months and for the full length of the study,
d. high risk for developing an immunocompromising disease