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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02381418




Registration number
NCT02381418
Ethics application status
Date submitted
3/03/2015
Date registered
6/03/2015
Date last updated
22/12/2016

Titles & IDs
Public title
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the Southern Hemisphere 2015 Season
Scientific title
Immunogenicity, Reactogenicity and Safety of the Trivalent Influenza Subunit Vaccine Influvac® for the Southern Hemisphere Season 2015. An Open-Label, Baseline-Controlled Study in Two Age Groups: Adult Subjects = 18 and = 60 Years and Elderly Subjects = 61 Years of Age
Secondary ID [1] 0 0
INFL3014
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Trivalent influenza subunit vaccine Influvac

Experimental: 1 - Trivalent influenza subunit vaccine Influvac. "3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "


Other interventions: Trivalent influenza subunit vaccine Influvac
"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. - Seroprotection and Seroconversion Rate for A/H1N1, A/H3N2, and B Strains 3 weeks After Vaccination in non-elderly adults and elderly adults.
Timepoint [1] 0 0
3 weeks post vaccination
Primary outcome [2] 0 0
the Serum Antihemagglutinin Antibody Titers and the Derived Parameters Defined in the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance on Harmonization of Requirements for Influenza Vaccines for Influenza Vaccines. - Mean fold increase in HI antibody titer 3 weeks After Vaccination in non-elderly adults and elderly adults.
Timepoint [2] 0 0
3 weeks post vaccination
Secondary outcome [1] 0 0
Safety (Unsolicited Adverse Events) and Tolerability (Reactogenicity and Overall Inconvenience) of Influvac®.
Timepoint [1] 0 0
up to 3 weeks post vaccination

Eligibility
Key inclusion criteria
- Willing and able to give informed consent and able to adhere to all protocol required
study procedures.

- Men and women aged = 18 and = 60 years or = 61 years of age at the day of study
vaccination.

- Being in good health as judged by medical history, physical examination (if needed)
and clinical judgment of the Investigator
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of
the vaccine.

- A serious adverse reaction after a previous (influenza) vaccination.

- Presence of any significant condition that may prohibit inclusion as determined by the
investigator.

- Seasonal or pandemic influenza vaccination or laboratory confirmed seasonal or
pandemic influenza infection within the previous six months before study vaccination
or planned vaccination during the study period.

- A history of Guillain-Barré syndrome or active neurological disease.

Study design
Purpose of the study
Prevention
Allocation to intervention
N/A
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Research Facility ID ORG-001075 - Maroubra
Recruitment postcode(s) [1] 0 0
NSW 2035 - Maroubra

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Abbott
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Influenza (flu) viruses change continuously, therefore also the parts of viruses used in
influenza vaccines can vary from year to year. The current study is a phase III A clinical
trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. The
objective of this study is to investigate the immunogenicity and safety and tolerability of
the changed influenza vaccine virus composition in two groups of subjects in good health:
subjects aged >= 18 and <= 60 years and subjects >= 61 years of age (elderly).
Trial website
https://clinicaltrials.gov/show/NCT02381418
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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
Other publications