A Phase IV, Single-Centre, Observer-Blind, Controlled, Randomized Study to Compare the Safety and Immunogenicity of Fluvirin® to Influvac® Administered to Healthy Children 3 to 12 Years of Age. - Fluvirin Paediatric Trial
- Conditions
- Prophylaxis of influenza
- Registration Number
- EUCTR2006-002649-35-GB
- 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
- 0
Subjects eligible for enrollment into this Phase IV trial are male and female paediatric subjects who are:
1) children of 3 years to <12 years of age, whose parents or legal guardians have given written informed consent prior to study entry
2) available for all the visits scheduled in the study
3) 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
Individuals are not to be enrolled into the study if:
1) they have any serious disease including, for example:
a. cancer (except for benign or localized skin cancer not presently treated with chemotherapy)
b. autoimmune disease (including rheumatoid arthritis),
c. advanced arteriosclerotic disease or complicated diabetes mellitus,
d. chronic obstructive pulmonary disease (COPD) that requires oxygen therapy,
e. acute or progressive hepatic disease,
f. acute or progressive renal disease
g. congestive heart failure
2) they have a history of any anaphylaxis, serious vaccine reactions, they are hypersensitive to ovalbumin, chicken protein, chicken feathers, influenza viral protein, thiomersal, neomycin or polymyxin or any other component of the vaccine
3) they have a known or suspected impairment/alteration of immune function, resulting from:
a. receipt of immunosuppressive therapy (corticosteroids -except topical or inhaled steroids- or cancer chemotherapy/radiotherapy) within the past 60 days and for the full length of the study
b. receipt of immunostimulants
c. high risk for developing an immunocompromising disease (suspected or known HIV infection or HIV-related disease)
4) receipt of parenteral immunoglobulin preparation, blood products and/or plasma derivates within the past 3 months and for the full length of the study;
5) within the past six months they have had laboratory confirmed influenza disease
6) have ever received influenza vaccine
7) within the past four weeks they have received another vaccine or any investigational agent
8) within the past 7 days, they have experienced:
· any acute disease;
· infections requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable);
9) within the past 3 days they have experienced fever (defined as axillary temperature =38°C)
10) any condition which, in the opinion of the investigator, might interfere with the evaluation of the study objectives
11) participation to another clinical trial
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