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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01677676




Registration number
NCT01677676
Ethics application status
Date submitted
24/08/2012
Date registered
3/09/2012
Date last updated
29/07/2013

Titles & IDs
Public title
Safety, Tolerability and Immunogenicity of Two Different Formulations of an Influenza A Vaccine (FP-01.1)
Scientific title
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)
Secondary ID [1] 0 0
FP-01.1_CS_02
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza A 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - FP-01.1
Other interventions - FP-01.1-Adjuvant

Active Comparator: Group 2 - FP-01.1 (250µg/peptide)

Active Comparator: Group 3 - FP-01.1-Adjuvant (150µg/peptide / 10.8mg)

Active Comparator: Group 4 - FP-01.1-Adjuvant (250µg/peptide / 18mg)

Active Comparator: Group 1 - FP-01.1 (150µg/peptide)


Other interventions: FP-01.1
IM injection

Other interventions: FP-01.1-Adjuvant
IM injection
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number and proportion of subjects reporting solicited local reactions and severity of the local reactions
Timepoint [1] 0 0
Day 1-57
Primary outcome [2] 0 0
To assess and compare the immunogenicity response between groups
Timepoint [2] 0 0
Day 1-57
Primary outcome [3] 0 0
Number and proportion of subjects reporting solicited systemic events
Timepoint [3] 0 0
Day 1-57, optional safety FU day 209
Primary outcome [4] 0 0
Number and proportion of subjects reporting unsolicited AEs and Serious Adverse Events (SAEs)
Timepoint [4] 0 0
Day 1-57, optional safety follow up at day 209
Primary outcome [5] 0 0
Number and proportion of subjects with abnormal haematology, blood chemistry lab assessments
Timepoint [5] 0 0
Day 1-57
Primary outcome [6] 0 0
Number and proportion of subjects with abnormal vital signs/ECG assessments
Timepoint [6] 0 0
Day 1-57
Secondary outcome [1] 0 0
Exploratory immunogenicity tests on samples obtained from subjects
Timepoint [1] 0 0
Day 1-57

Eligibility
Key inclusion criteria
1. Age 18 to 55 years inclusive at the time of consent

2. 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.

OR

• 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)

3. 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.

4. An understanding, ability and willingness to fully comply with study procedures and
restrictions

5. Ability to provide written, personally signed and dated informed consent to
participate in the study.

6. 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.

7. The subject is willing to present a study prepared letter to a General Practitioner
(GP) if visiting for any purpose

8. Subject is willing to refrain from consuming alcohol for 24h prior to all visits.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. As a result of the medical screening process, the Principal Investigator or
Co-Investigator considers the subject unfit for the study.

2. 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.

3. Significant illness as judged by the Principal Investigator or Co-Investigator within
2 weeks of the first dose of IMP.

4. 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.

5. 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.

6. Known or suspected intolerance or hypersensitivity to the IMP, or closely related
compounds or any of the stated ingredients

7. History of alcohol or other substance abuse within the last year. A positive screen
for alcohol or drugs of abuse.

8. 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.

9. A positive HIV antibody screen, Hepatitis B surface antigen, Hepatitis B core
antibody, or Hepatitis C antibody screen

10. 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.

11. Donation of blood or blood products (e.g. plasma, platelets) within 90 days prior to
or intention to donate blood during the entire study.

12. Use of another investigational medicinal product within 90 days prior to receiving the
first dose of IMP or intention to enrol in another clinical study throughout the
entire study (up to and including Day 57), including the 6 month follow-up period for
those subjects who consent to remain on study for this follow-up.

13. Subject with suspected recent (=12 months) pre-exposure to the influenza A virus - flu
like symptoms associated with = 2 days off normal daily activities

14. Subjects who have received a flu vaccine in the last 12 months or who anticipate
receiving it within the duration of the clinical phase of the study (ie up to
completion of Day 57) or the period up to the 6 month safety follow-up telephone call,
for the subjects who consent to remain on study for this follow-up.

15. Any clinically significant abnormalities, in the opinion of the Principal Investigator
or Co-Investigator, on electrocardiograms (ECGs), as assessed against the clinical
site's reference range.

In addition, for each subject, a completed medical history questionnaire will be taken as
part of the consented study procedure.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2012
Sample size
Target
Accrual to date
Final
48
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Q-Pharm Pty Ltd - Brisbane
Recruitment postcode(s) [1] 0 0
4006 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Immune Targeting Systems Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
INCResearch Australia Pty Limited
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01677676
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joanne Marjason
Address 0 0
Q-Pharm Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01677676