Influenza Clinical Trial
Official title:
Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 6 Months to 36 Months |
Eligibility |
Inclusion Criteria: - Children aged 6 to 36 months, both sexes; - Are in good health (as determined by vital signs and existing medical condition) or are in stable medical condition. Subjects will not be excluded with known adequately treated clinically significant organ or systemic diseases (e.g. asthma or diabetes), such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study; - Capability of the legitimate representative of the volunteer to understand and comply with planned study procedures; - Legitimate representative of the volunteer provide written informed consent prior to initiation of study procedures; - Absence of existence of any exclusion criteria. Exclusion Criteria: - Known allergy to eggs or other components of the vaccine (in particular mercury); - History of Guillain-Barré syndrome; - Active neoplasm; - Former or on-going immunosuppressive therapy; - Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids; - Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; - Documented HIV, HBV or HCV infection; - Chronic illness that, in the opinion of the investigator, may have effect on the participation in the study; - Acute febrile respiratory illness within one week prior to vaccination; - Vaccine therapy within 4 weeks prior to vaccination; - Influenza vaccination within 6 months prior to vaccination; - Experimental drug therapy within 1 month prior to vaccination; - Past or current psychiatric disease of the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the legitimate representative; - Alcohol or drug abuse of the legitimate representative. |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Hungary | "Csolnoky Ferenc" Veszprém County Hospital | Veszprém |
Lead Sponsor | Collaborator |
---|---|
Omninvest Vaccine Manufacturing, Researching and Trading Ltd. |
Hungary,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of adverse events | To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination. | 28 days after vaccination | Yes |
Secondary | Incidence of adverse events | To assess safety of the study drug after Day 180-210 following the vaccination. | 180-210 days after vaccination | Yes |
Secondary | Efficacy of the study drug | To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination. | 180-210 days after vaccination | No |
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