Immunogenicity and Tolerability Study of Fluval AB Novo Suspension for Injection for Children and Adolescents

NCT02387294 | Completed Phase 3 Results DMC

• 1 other identifier: FABNovo-H-16
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Influenza

Keywords

immunogenicity; reduced dose; Phase III; tolerability; safety

Outcome Measures

Primary Outcomes (9)

• Increase in Geometric Mean Titre Ratio, A/H1N1 Strain

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5

  21-28 days after vaccination

• Increase in Geometric Mean Titre Ratio, A/H3N2 Strain

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5

  21-28 days after vaccination

• Increase in Geometric Mean Titre Ratio, B Strain

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement: \> 2.5

  21-28 days after vaccination

• Seroconversion, A/H1N1 Strain

  Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %

  21-28 days after vaccination

• Seroconversion, A/H3N2 Strain

  Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %

  21-28 days after vaccination

• Seroconversion, B Strain

  Proportion of subjects seroconverted or had a significant increase in titres Requirement: \> 40 %

  21-28 days after vaccination

• Seroprotection, A/H1N1 Strain

  Proportion of subjects seroprotected Requirement: \> 70 %

  21-28 days after vaccination

• Seroprotection, A/H3N2 Strain

  Proportion of subjects seroprotected Requirement: \> 70 %

  21-28 days after vaccination

• Seroprotection, B Strain

  Proportion of subjects seroprotected Requirement: \> 70 %

  21-28 days after vaccination

Study Arms (2)

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.

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

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.

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

Interventions

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

vaccination

Also known as: Fluval AB Novo suspension for injection

Age group 1: children (3-11 years)

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

vaccination

Age group 2: adolescents (12-18 years)

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Fluart Innovative Vaccine Ltd, Hungary: lead

MeSH Terms

Conditions

Influenza, Human

Interventions

Vaccination; Injections

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Immunotherapy, Active; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques; Primary Prevention; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Drug Administration Routes; Drug Therapy

Results Point of Contact

• Title: Zsolt Németh
• Organization: Fluart Innovative Vaccines Ltd

info@fluart.hu

+3620

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel-group study in two paediatric age groups

Study Record Dates

• First Submitted: October 16, 2014
• First Posted: March 13, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 11, 2021
• Results First Posted: March 11, 2021

Record last verified: 2015-03