A Phase III, randomized, observer-blind, controlled, multi-center clinical study to evaluate the efficacy, safety and immunogenicity of one and two intramuscular doses of FLUAD versus control vaccines in unprimed healthy subjects aged between 6 and up to 72 months.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 3500

Inclusion Criteria

1) Children of 6 to <36 months of age, whose parents/legal guardians have given written informed consent prior to study entry,

2) 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) Administration of licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. All routine vaccines should be given according to local recommendations: routine vaccines or any other vaccines not foreseen in the protocol can be given after the active trial phase (i.e. 3 weeks after last vaccination in the respective season) has been concluded.
2) Receipt of another investigational vaccine or any investigational agent within 30 days prior to study start.
3) Administration of any other investigational agent (other than the study vaccine) throughout the entire study period.
4) 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).
5) Any severe acute respiratory disease and infection requiring systemic antibiotic or antiviral therapy ongoing or resolved within 2 days prior to study start (chronic antibiotic therapy for urinary tract prophylaxis is acceptable)
6) Fever (defined as axillary temperature = 38°C/rectal temperature = 38.5°C) within the 2 days before enrollment
7) 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
8) Known or suspected impairment/alteration of immune function, for example, resulting from:
a.receipt of immunosuppressive therapy (corticosteroid -except topical or inhaled steroids- or cancer chemotherapy),
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
9) Bleeding diathesis
10) History of hypersensitivity to any component of the study medication or chemically related substances
11) History of any anaphylaxis, serious vaccine reactions, or allergy to eggs, egg products or any other vaccine component
12) Laboratory confirmed influenza disease in the past 6 months
13) History of neurological disorder or seizures (febrile seizures allowed)
14) Ever received any influenza vaccine
15) Major surgery planned during the study period
16) Any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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