Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (Trivalent, Seasonal Influenza Vaccine, Active Ingredient Content: 6 μg HA/Strain/0.5 ml) for Children and Adolescents

Fluart Innovative Vaccine Ltd, Hungary0 sites120 target enrollmentStarted: October 1, 2014Last updated: March 11, 2021

Conditions

Interventions

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: Fluart Innovative Vaccine Ltd, Hungary
Enrollment: 120
Primary Endpoint: Seroconversion, A/H1N1 Strain

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/strain/0.5 ml) for Children and Adolescents.

Detailed Description

STUDY PERIOD:

Length of enrollment: 2 weeks (estimated) Participation per subject: max. 1 month

OBJECTIVES:

Immunogenicity Objectives:

To assess immunogenicity of a single intramuscular injection of Fluval AB Novo suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 6 μg HA/0.5 ml of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Study Design

Study Type: Interventional
Allocation: Non Randomized
Intervention Model: Single Group
Primary Purpose: Prevention
Masking: None

Eligibility Criteria

Ages: 3 Years to 18 Years (Child, Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•Children aged 3 to 11 years, adolescents aged 12 to 18 years from 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;
•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 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;
•Adolescent participants aged 12 to 18 years and the legitimate representative of all volunteers provide written Informed Consent (IC) prior to initiation of study procedures;
•Absence of existence of any

Exclusion Criteria

•Exclusion Criteria:
•Pregnancy, breast feeding or positive urine pregnancy test at baseline prior to vaccination. Female subjects who are able to bear children but not willing to use an acceptable contraception method for the duration of the study.
•Known hypersensitivity to eggs, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin, vancomycin or any other component of the vaccine;
•History of Guillain-Barré syndrome;
•History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
•Serious disease, such as cancer, autoimmune disease, advanced arteriosclerotic disease, complicated diabetes mellitus, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure;
•Immunosuppressive therapy within 36 months prior to vaccination;
•Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
•Receipt of immunostimulants,
•Receipt of parenteral immunoglobulin, blood products and/or plasma derivate within 3 months prior to vaccination;
•Suspected or known HIV, HBV or HCV infection;
•Acute disease and/or axillary temperature ≥37oC within 3 days prior to vaccination;
•Vaccine therapy within 4 weeks prior to vaccination;
•Influenza vaccination (any kind) within 6 months prior to vaccination;
•Experimental drug therapy within 4 weeks prior to vaccination;
•Concomitant participation in another clinical study;
•Any condition which, in the opinion of the investigator, may interfere with the evaluation of the study;
•Past or current psychiatric disease of the volunteer or the legitimate representative that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
•Alcohol or drug abuse of the participant or the legitimate representative.

Arms & Interventions

Age group 1: children (3-11 years)

Experimental

Intervention: Vaccination with Fluval AB Novo suspension for injection.

Dosage: Half dose of a single dose (0.25 ml) vaccine, administered intramuscularly.

Intervention: Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml) (Biological)

Age group 2: adolescents (12-18 years)

Experimental

Intervention: Vaccination with Fluval AB Novo suspension for injection.

Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.

Intervention: Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml) (Biological)