Influenza
Conditions
Keywords
Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children
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.
Interventions
BIOLOGICALVaccination with FLUVAL P
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant. Dose: 0.25 ml (total 3 μg HA), single dose.
Sponsors
Fluart Innovative Vaccine Ltd, Hungary
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
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
.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 28 days after vaccination | To assess tolerability/safety (incidence of adverse events) of the study drug after Day 28 following the vaccination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 180-210 days after vaccination | To assess safety of the study drug after Day 180-210 following the vaccination. |
| Efficacy of the study drug | 180-210 days after vaccination | To assess the efficacy of the study drug by epidemiological follow-up of the participants until Day 180-210 following the vaccination. |
Countries
Hungary
Outcome results
None listed