Evaluate the Safety, Tolerability, and Immunogenicity of Fluad and Agriflu
- Conditions
- Prevent the attack rates of influenza during both pandemic and interpandemic periods..Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2014-005053-40-Outside-EU/EEA
- Lead Sponsor
- ovartis Vaccines and Diagnostics S.r.l
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 5750
Children 6 months to 72 months of age
Are the trial subjects under 18? yes
Number of subjects for this age range: 5750
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
1.Who had been hospitalized at the time of enrollment
2.Who had any serious reaction or hypersensitivity to any vaccine component, eggs, or chicken protein
3.Who had known impairment of the immune function
4.Who had fever interfering with normal daily activities at the time of enrollment
5.Who had received licensed vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in the study
6.Concomitant participation in another clinical study
7.Who had surgery planned during the study period that in the investigator's opinion would have interfered with the study visits schedule.
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