A Randomised, Double-Blind, Double Observer, Study to Assess the Safety, Tolerability and Immunogenicity of Repeated Intramuscular Administration of Two Different Formulations of an Influenza A Vaccine (FP-01.1)

Immune Targeting Systems Ltd1 site in 1 country48 target enrollmentJanuary 2012

ConditionsInfluenza A

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Influenza A
Sponsor: Immune Targeting Systems Ltd
Enrollment: 48
Locations: 1
Primary Endpoint: Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study has been designed to evaluate the safety and immunogenicity of two different formulations of FP-01.1 as well as build on the data set from the first in human study FP-01.1_CS_01. It is anticipated that the results of this Phase I study will inform the best formulation of the vaccine to evaluate in efficacy studies.

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

September 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Immune Targeting Systems Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 to 55 years inclusive at the time of consent
•Willing to comply with the applicable contraceptive requirements of the protocol
•For male subjects, agreement to use a barrier method (condom) as a method of birth control in addition to any contraceptive measures normally taken by his partner until completion of the Day 57 visit, and refrain from fathering a child at least until completion ofthe Day 57 visit. Male subjects do not need to use contraception if their partner has been through the menopause, or has had her womb or both her ovaries removed.
•For female subjects of childbearing potential, be surgically sterile or using an insertable, injectable, transdermal, or combination oral contraceptive approved by the TGA combined with a barrier contraceptive through to completion of the Day 57 visit study and have negative results on a serum or urine pregnancy test done before administration of study medication (women who are postmenopausal \[no menses for at least 2 years\] are also eligible to participate)
•Satisfactory medical assessment with no clinically significant or relevant abnormalities in medical history, physical examination, vital signs, ECG and laboratory evaluation (haematology, biochemistry or urinalysis) as assessed by the Investigator.
•An understanding, ability and willingness to fully comply with study procedures and restrictions
•Ability to provide written, personally signed and dated informed consent to participate in the study.
•The subject has a body mass index (BMI) within the range 19.0-32.0 kg/m2 and falls within the weight range of 50.0-100.0 kg.
•The subject is willing to present a study prepared letter to a General Practitioner (GP) if visiting for any purpose
•Subject is willing to refrain from consuming alcohol for 24h prior to all visits.

Exclusion Criteria

•As a result of the medical screening process, the Principal Investigator or Co-Investigator considers the subject unfit for the study.
•Current, chronic or recurrent disease (e.g. cardiovascular, respiratory, endocrine, renal, liver, gastrointestinal, autoimmune, immune suppression, malignancy or other conditions) that could affect the action, absorption or disposition of the IMP or could affect clinical or laboratory assessments.
•Significant illness as judged by the Principal Investigator or Co-Investigator within 2 weeks of the first dose of IMP.
•Subjects with a history of allergies or allergic conditions including anaphylactic reactions, asthmatics, hay fever and eczema sufferers requiring medication which in the opinion of the Principal Investigator or Co-Investigator will affect their participation in the study.
•Subjects receiving medications that affect the immune system including systemic steroids and patients on chronic medications where the dose has not been stable for at least 3 months.
•Known or suspected intolerance or hypersensitivity to the IMP, or closely related compounds or any of the stated ingredients
•History of alcohol or other substance abuse within the last year. A positive screen for alcohol or drugs of abuse.
•Male subjects who consume more than 21 units of alcohol per week and female subjects who consume more than 14 units of alcohol per week.
•A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core antibody, or Hepatitis C antibody screen
•Subjects who have significant scarring, tattoos, abrasions, cuts or infections, that in the opinion of the Investigator could interfere with evaluation of injection site local reactions, over the deltoid region of both arms as these will be the dose site.