Tolerability and Immunogenicity Study of Fluval AB Suspension for Injection

NCT01863849 | Completed Phase 4 Results

• 1 other identifier: FluvalAB-H-YL2013
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

Brief Summary

To assess immunogenicity of a single intramuscular injection of Fluval AB suspension for injection (trivalent, seasonal influenza vaccine, active ingredient content: 15 μgHA/0.5mL of seasonal A/H1N1, A/H3N2 and B influenza antigens each), as measured by haemagglutination inhibition (HI) test.

Conditions

Influenza Prophylaxis

Keywords

uncontrolled; open; multi-centre; immunogenicity and tolerability; two groups according to age (18-59 years and ≥60 years)

Outcome Measures

Primary Outcomes (9)

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

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

  21-28 days after vaccination

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

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

  21-28 days after vaccination

• Change in Geometric Mean Titre Ratio, B Strain

  Ratio of Day 0 and Day 21-28 antihaemagglutination inhibition titres Requirement (Age group 1): ≥ 2.5 Requirement (Age group 2): ≥ 2.0

  21-28 days after vaccination

• Seroconversion, A/H1N1 Strain

  Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %

  21-28 days after vaccination

• Seroconversion, A/H3N2 Strain

  Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %

  21-28 days after vaccination

• Seroconversion, B Strain

  Percentage of subjects seroconverted or had a significant increase in titres Requirement (Age group 1): \> 40 % Requirement (Age group 2): \> 30 %

  21-28 days after vaccination

• Seroprotection, A/H1N1 Strain

  Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %

  21-28 days after vaccination

• Seroprotection, A/H3N2 Strain

  Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %

  21-28 days after vaccination

• Seroprotection, B Strain

  Percentage of subjects seroprotected Requirement (Age group 1): \> 70 % Requirement (Age group 2): \> 60 %

  21-28 days after vaccination

Study Arms (2)

Age group 1: adults (18-59 years)

EXPERIMENTAL

Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.

Biological: Vaccination with Fluval AB suspension for injection

Age group 2: elderly (> 60 years)

EXPERIMENTAL

Intervention: Vaccination with Fluval AB suspension for injection. Dosage: A single dose (0.5 ml) vaccine, administered intramuscularly.

Biological: Vaccination with Fluval AB suspension for injection

Interventions

Vaccination with Fluval AB suspension for injection BIOLOGICAL

Single intramuscular injection with Fluval AB suspension for injection in both age groups

Age group 1: adults (18-59 years); Age group 2: elderly (> 60 years)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult persons aged 18 to 59 years, elderly persons aged ≥60 years from both sexes, mentally competent;
• 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 aged 18-59 years (i.e. participants 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 participants to understand and comply with planned study procedures;
• Participants 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, chicken protein, 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

Study Sites (3)

Family Doctor's Office

Budapest, 1083, Hungary

Location

District Doctor's Office

Pilisvörösvár, H-2085, Hungary

Location

District Doctor's Office

Szentendre, H-2000, Hungary

Location

MeSH Terms

Interventions

Vaccination; Injections

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

Study Officials

• Zsolt Németh

  Fluart Innovative Vaccines Ltd.

  STUDY CHAIR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: parallel-group, in two age groups

Study Record Dates

• First Submitted: May 23, 2013
• First Posted: May 29, 2013
• Study Start: August 22, 2013
• Primary Completion: September 17, 2013
• Study Completion: September 17, 2013
• Last Updated: April 5, 2021
• Results First Posted: April 5, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3)