Influenza, Human, Novel 2009 Influenza H1N1
Conditions
Keywords
Influenza, Pandemic vaccine, Seasonal vaccine, Prevention, Influenza vaccine, Influenza in humans, Pandemic influenza in humans, Influenza vaccine for children, Influenza vaccine for adolescents, Seasonal vaccine for children, Seasonal vaccine for adolescents
Brief summary
This is a single-blind, reference drug controlled study to assess safety and tolerability of FLUVAL P H1N1 monovalent influenza vaccine (whole virus, inactivated, adjuvanted with alumn phosphate gel) containing 6 mcgHA per 0.5mL active ingredient in children and adolescents. To assess, as secondary objective, the efficacy (immunogenicity) of the vaccine by serology testing.
Detailed description
Primary Objective: * To assess tolerability/safety (incidence of adverse events 21-28 days following vaccination) of the study drug. Secondary Objectives: * To assess the efficacy (immunogenicity) of the study drug by serology testing of blood samples taken at Day 21-28 after immunization in groups and age groups. * To assess long term (180-210 days following vaccination) tolerability/safety (incidence of adverse events) of the study drug.
Interventions
* 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/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose.
BIOLOGICALVaccination with Fluval AB
* Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose.
BIOLOGICALVaccination with Fluval AB Novo
* Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant. * Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose.
Sponsors
Fluart Innovative Vaccine Ltd, Hungary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Children aged 3 to 12 years, adolescents aged 12 to 18 years, 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)m such that, in the opinion of the investigator, the significance of the disease will not compromise the subject's participation in the study. * Female volunteers of childbearing potential with a negative result from the urine pregnancy test prior to vaccination who agrees to use an acceptable contraception method (includes implants, injectibles, combined oral contraceptives, effective intrauterine devices /IUDs/, sexual abstinence, or a vasectomized partner) or abstinence throughout the trial and not become pregnant for the duration of the study. * Capability of adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers to understand and comply with planned study procedures; * Absence of existence of any
Exclusion criteria
.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 21-28 days after vaccination |
Secondary
| Measure | Time frame |
|---|---|
| Post vaccination HI antibody titer | 21-28 days after vaccination |
| Incidence of adverse events | 180-210 days after vaccination |
Countries
Hungary
Outcome results
None listed