Clinical trial NCT01100294: Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Official title: Tolerability and Safety Study of FLUVAL P Monovalent Influenza Vaccine in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Pandemic vaccine
Seasonal vaccine
Prevention
Influenza vaccine
Influenza in humans
Pandemic influenza in humans
Influenza vaccine for children
Lead sponsor: Fluart Innovative Vaccine Ltd, Hungary
Sponsor class: INDUSTRY
First posted: 2010-04-08
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To determine the tolerability and safety of FLUVAL P monovalent influenza vaccine in children.

Detailed description: This is an open, uncontrolled study to assess safety and tolerability of Fluval P monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children of 6-36 months of age. The vaccination is not repeated.

Tolerability and safety (incidence of adverse events) of the study drug is assessed after Day 28 then after Day 180-210 following the vaccination.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of adverse events
timeFrame: 28 days after vaccination
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 180-210 days after vaccination
measure: Efficacy of the study drug
timeFrame: 180-210 days after vaccination
Other outcomes:
Locations:
city: Veszprém
country: Hungary
facility: "Csolnoky Ferenc" Veszprém County Hospital
Study officials:
affiliation: Omninvest Ltd.
name: Anna Ősi, Dr.
role: STUDY_DIRECTOR
affiliation: "Csolnoky Ferenc" Veszprém County Hospital
name: Éva Szabó, MD
role: PRINCIPAL_INVESTIGATOR
References: