Safety and Immunogenicity Study of Fluval AB-Like Flu Vaccines With 3.5, 6, 9 or 15 μg HA in Adult and Elderly People

Influenza Clinical Trial

Official title:

A Randomized, Double Blind, Multicentre Study to Evaluate Safety and Immunogenicity of Four Fluval AB-Like Influenza Vaccines With 3.5 μgHA, 6 μgHA, 9 μgHA Or 15 μgHA Of A/H1N1, A/H3N2 and B Influenza Antigens in Adult and Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01408290
• Other study ID #: FluvalAB-H-14
• Secondary ID: 2011-003166-32
• Status: Completed
• Phase: N/A
• First received: August 1, 2011
• Last updated: May 18, 2012
• Start date: September 2011
• Est. completion date: October 2011

Study information

• Verified date: May 2012
• Source: Omninvest Vaccine Manufacturing, Researching and Trading Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hungary: National Institute of Pharmacy
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the immunogenicity, tolerability and dose-effect relationship of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens in adults and elderly people.

Description:

Primary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL intramuscular (IM) injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by haemagglutination inhibition (HI) test 21 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.

• To determine dose-effect relationship between one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens and immune response provoked 21 days after vaccination in terms of pre- and postimmunization HA titers as measured by HI test.

Secondary immunogenicity objectives

• To assess immunogenicity of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA, 9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens, as measured by HI test 14 days after vaccination in compliance with the requirements of the current European Union recommendations as determined in CPMP/BWP/214/96.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 21 days after vaccination.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of post-immunization HA titers as measured by HI test 14 days after vaccination.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 21 after vaccination.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of the percentage of subjects achieving seroconversion or significant increase in antibody titer at day 14 after vaccination.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 21/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.

• To find the highest dose of FLUVAL AB-like trivalent influenza vaccine among 3.5μgHA, 6μgHA and 9μgHA the response of which differs from that of dose 15μgHA in terms of Day 14/Day 0 geometric mean titer ratios (GMTRs) as determined by HI.

Safety and tolerability objective

• To evaluate the safety of the administration of one 0.5 mL IM injection of four FLUVAL AB-like trivalent influenza vaccines containing either 3.5μgHA, 6μgHA,9μgHA or 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• male and female adult volunteers aged 18 years or older,

• mentally competent,

• able to understand and comply with all study requirements,

• willing and able to give written informed consent prior to initiation of study procedures,

• in good health (as determined by clinical judgement of the investigator on the basis of medical history 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 subjects aged 18 to 60 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.

• 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.

• Hypersensitivity to eggs, chicken protein, thiomersal, formaldehyde, gentamycin, ciprofloxacin, neomycin or any other component of the vaccine;

• History of anaphylactic shock or neurological symptoms or signs following administration of any vaccine;

• History of Guillain-Barré syndrome;

• 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 the past 36 months;

• Concomitant corticosteroid therapy, including high-dose inhaled corticosteroids;

• Receipt of immunostimulants;

• Receipt of parenteral immunoglobulin, blood products and/or plasma derivates within the past 3 months;

• Suspected or known HIV, HBV or HCV infection;

• Acute disease and/or axillary temperature =37oC within the past 3 days;

• Vaccine therapy within the past 4 weeks;

• Influenza vaccination (any kind) within the past 6 months;

• Experimental drug therapy within the past 4 weeks;

• 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 subject that upon judgement of the investigator may have effect on the objective decision-making of the subject;

• Alcohol or drug abuse of the subject.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Vaccination with FAB-3511
One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
• Vaccination with FAB-6011
One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
• Vaccination with FAB-9011
One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
• Vaccination with FluvalAB
One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15µgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.

Locations

Country	Name	City	State
Hungary	Family Doctor's Office	Budapest
Hungary	Family Doctor's Office	Budapest
Hungary	Family Doctor's Office	Dunakeszi	Pest
Hungary	Family Doctor's Office	Szentendre	Pest

Sponsors (1)

Lead Sponsor	Collaborator
Omninvest Vaccine Manufacturing, Researching and Trading Ltd.

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MEASURES OF IMMUNOGENICITY	The measures of immunogenicity, for all evaluable subjects by using HI test are: the GMTs at Day 0, at Day 14 and at Day 21 as determined by HI; the Day 14/Day 0, the Day 21/Day 0 and the Day 21/Day 14 geometric mean titer ratios (GMTRs) as determined by HI; the percentage of subjects achieving seroconversion1 or significant increase in antibody titer2 at Day 14 an at Day 21, as determined by HI; the percentage of subjects achieving a titer =40 at Day 0, at Day 14 and at Day 21 as determined by HI.	21-28 days following vaccination	No
Secondary	MEASURES OF SAFETY	Number and percentage of subjects with at least one local reaction between Day 0 and Day 7 after vaccination.; Number and percentage of subjects with at least one systemic reaction between Day 0 and Day 7 after vaccination.; Number and percentage of subjects with at least one adverse event between Day 0 and the study termination visit at Day 21.	21-28 days following vaccination	Yes