search
Back to results

Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Vaccination with Fluval P and Fluval AB influenza vaccines
Vaccination with Fluval P monovalent influenza vaccine
Sponsored by
Fluart Innovative Vaccine Ltd, Hungary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring pandemic, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Adults aged 18 to 60 years, elderly people aged over 60 years, from both sexes, with full contractual capacity;
  • 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;
  • Femal 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.
  • Capable of understanding and complying with study protocol requirements;
  • The volunteers provide written informed consent prior to initiation of study procedures;
  • Absence of existence of any exclusion criteria.

Exclusion Criteria:

  • Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination;
  • Known allergy to eggs or other components of the vaccine (in particular mercury);
  • History of Guillain-Barré syndrome;
  • Active neoplasm;
  • Immunosuppressive therapy in the preceding 36 months;
  • Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;
  • Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination;
  • Documented HIV, HBV or HCV infection;
  • Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse;
  • Acute febrile respiratory illness within one week prior to vaccination;
  • Vaccine therapy within 4 weeks prior to vaccination;
  • Influenza vaccination within 6 months prior to vaccination;
  • Experimental drug therapy within 1 month prior to vaccination;
  • Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer;
  • Alcohol or drug abuse of the participant.

Sites / Locations

  • District Doctor's Office
  • Fourmed Kft. Gyogyhaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Influenza vaccination

Influenza vaccination and co-vaccination

Arm Description

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose).

Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).

Outcomes

Primary Outcome Measures

Post vaccination HI antibody titer
Incidence of adverse reactions

Secondary Outcome Measures

Incidence of adverse reactions

Full Information

First Posted
November 7, 2009
Last Updated
May 18, 2012
Sponsor
Fluart Innovative Vaccine Ltd, Hungary
search

1. Study Identification

Unique Protocol Identification Number
NCT01010893
Brief Title
Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine
Official Title
Tolerability and Immunogenicity Study of FLUVAL P Monovalent Influenza Vaccine in Adults and Elderly Persons
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fluart Innovative Vaccine Ltd, Hungary

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the tolerability and immunogenicity of FLUVAL P monovalent influenza vaccine in adults and elderly people, with the objective to verify efficacy and tolerability of the study drug.
Detailed Description
Primary Objective: To assess tolerability/safety (incidence of adverse events) of the study drug. 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. Secondary Objectives: To assess the long-term safety of the study drug 50-60 days after immunization. To determine the tolerability of simultaneous administration of FLUVAL P monovalent pandemic influenza vaccine and FLUVAL AB trivalent seasonal influenza vaccine in case of adults and elderly people. To assess the efficacy of the study drug by optional epidemiological follow-up of the participants until the end of the influenza season. To assess the immunogenicity of the study drug by optional cross-reactive immunity tests performed with non-homologous influenza A and B virus strains.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
pandemic, prevention, influenza, infection, influenza vaccine, vaccine, influenza in humans

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
355 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Influenza vaccination
Arm Type
Experimental
Arm Description
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose).
Arm Title
Influenza vaccination and co-vaccination
Arm Type
Experimental
Arm Description
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Intervention Type
Biological
Intervention Name(s)
Vaccination with Fluval P and Fluval AB influenza vaccines
Other Intervention Name(s)
Influenza, Pandemic vaccine, Seasonal vaccine, Co-vaccination, Prevention, Innfluenza vaccine, Influenza in humans
Intervention Description
Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 6 μg HA/ in both age groups, single dose) AND with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant (dose: 0.5 ml /total 3x15 μg HA/ in both age groups, single dose).
Intervention Type
Biological
Intervention Name(s)
Vaccination with Fluval P monovalent influenza vaccine
Other Intervention Name(s)
pandemic, influenza, prevention, vaccine, influenza vaccine, influenza in humans
Intervention Description
Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant
Primary Outcome Measure Information:
Title
Post vaccination HI antibody titer
Time Frame
21-28 days after vaccination
Title
Incidence of adverse reactions
Time Frame
21-28 days after vaccination
Secondary Outcome Measure Information:
Title
Incidence of adverse reactions
Time Frame
50-60 days after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults aged 18 to 60 years, elderly people aged over 60 years, from both sexes, with full contractual capacity; 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; Femal 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. Capable of understanding and complying with study protocol requirements; The volunteers provide written informed consent prior to initiation of study procedures; Absence of existence of any exclusion criteria. Exclusion Criteria: Pregnancy or breast feeding or positive urine pregnancy test at baseline prior to vaccination; Known allergy to eggs or other components of the vaccine (in particular mercury); History of Guillain-Barré syndrome; Active neoplasm; Immunosuppressive therapy in the preceding 36 months; Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids; Immunoglobulin (or similar blood product) therapy within 3 months prior to vaccination; Documented HIV, HBV or HCV infection; Chronic illness that, in the opinion of the investigator, may interfere with the evaluation of the immunoresponse; Acute febrile respiratory illness within one week prior to vaccination; Vaccine therapy within 4 weeks prior to vaccination; Influenza vaccination within 6 months prior to vaccination; Experimental drug therapy within 1 month prior to vaccination; Past or current psychiatric disease of the volunteer that upon judgement of the investigator may have effect on the objective decision-making of the volunteer; Alcohol or drug abuse of the participant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ferenc Tamas, MD
Organizational Affiliation
Pilisvorosvar District Doctor's Office
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anna Osi, Dr.
Organizational Affiliation
Omninvest Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
District Doctor's Office
City
Pilisvorosvar
ZIP/Postal Code
H-2085
Country
Hungary
Facility Name
Fourmed Kft. Gyogyhaz
City
Veszprem
ZIP/Postal Code
H-8200
Country
Hungary

12. IPD Sharing Statement

Citations:
PubMed Identifier
20018367
Citation
Vajo Z, Tamas F, Sinka L, Jankovics I. Safety and immunogenicity of a 2009 pandemic influenza A H1N1 vaccine when administered alone or simultaneously with the seasonal influenza vaccine for the 2009-10 influenza season: a multicentre, randomised controlled trial. Lancet. 2010 Jan 2;375(9708):49-55. doi: 10.1016/S0140-6736(09)62039-0. Epub 2009 Dec 15.
Results Reference
derived

Learn more about this trial

Tolerability and Immunogenicity of Fluval P Monovalent Influenza Vaccine

We'll reach out to this number within 24 hrs