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Trial registered on ANZCTR


Registration number
ACTRN12619000118101
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
25/01/2019
Date last updated
25/01/2019
Date data sharing statement initially provided
25/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Clinical Study of Pre and Post Vaccination Serology in Children Receiving the Seasonal Southern Hemisphere Formulation of Inactivated Influenza Vaccine
Scientific title
A Clinical Study of Pre and Post Vaccination Serology in Children Receiving the Seasonal Southern Hemisphere Formulation of Inactivated Influenza Vaccine
Secondary ID [1] 297008 0
Nil known
Universal Trial Number (UTN)
U1111-1226-4042
Trial acronym
FluKids
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 310984 0
Condition category
Condition code
Infection 309642 309642 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A total of 40 children (aged between 6 months and 9 years of age) will be enrolled into this research study. After written and informed parental consent, a 3ml blood sample will be collected to determine the baseline anti-haemagglutination antibody titre. The participant will then be administered the Licensed Quadrivalent Seasonal Influenza vaccine according to the Australian Immunisation Handbook (AIH) guidlines. At the last visit, a second 3ml blood sample will be collected for the determination of post-vaccination antibody titres.

All participants will receive an intramuscular injection of the seasonal licensed southern hemisphere seasonal influenza vaccine according to the Australian Immunisation Handbook recommendation. The World Health Organisation (WHO) provides a recommendation for the composition of the Southern Hemisphere influenza virus vaccines.

For Children aged 6 months to up to 3 years of age
FluQuadri Junior- Sanofi-Aventis Australia Pty Ltd (quadrivalent inactivated influenza virus). Each 0.25mL pre-filled syringe contains 7.5µg haemagglutinin of each of the four recommended influenza virus strains; 50µg formaldehyde; 125µg octoxinol 9; 0.5µg ovalbumin.

For Children aged 3 years of age and older
FluQuadri – Sanofi-Aventis Australia Pty Ltd (quadrivalent inactivated influenza virus). Each 0.5 mL pre-filled syringe contains 15 µg haemagglutinin of each of the four recommended influenza virus strains; 100 µg formaldehyde; 250 µg octoxinol 9; 1 µg ovalbumin.

According to the Australian Immunisation Handbook, children aged 6 months to <9 years receiving influenza vaccine for the first time require two doses, at least 4 weeks apart, to maximize the immune response to vaccine strains. For children who have previously received 1 or more doses of trivalent or quadrivalent influenza vaccine, only 1 dose of influenza vaccine is required in the current season and all seasons thereafter. Therefore participants in the study will receive either 1 or 2 doses of the quadrivalent influenza vaccine depending on whether they have ever received a prior influenza vaccine.

The duration of the study for each participant will be approximately 1-2 months, during which time they will be asked to:
• Attend up to three clinic visits at the Women’s and Children’s Hospital with a duration of up to 30 minutes.
• Receive a licensed seasonal influenza vaccine
• Have 2 blood samples taken (3ml) prior to and approximately 21 days after vaccination

The following study activities will occur as described below:

Visit 1
(Day 0 of the study)
Duration: 30 minutes
Consent process
Questions on age, gender, address, contact details, medical history, previous vaccinations and medications.
Blood draw (3ml).
Vaccination: Licensed Seasonal Influenza vaccine (quadrivalent)
Observation period for 15 mins after vaccination
Please note: children who have never received an influenza vaccine prior to participating in this study will require a third visit for a second dose of influenza vaccine 4 weeks after their first dose to maximise protection against influenza infection. Children who have previously been vaccinated with the seasonal influenza vaccine in previous years will only require 1 dose of the vaccine.

Visit 2 (for participants who have not had a prior influenza vaccine)
Duration: 30 minutes
Vaccination: Licensed Seasonal Influenza vaccine (quadrivalent)
Observation period for 15 mins after vaccination

Final visit (21+ 4 days post vaccination)
Duration: approx 15 min
Blood draw (3ml)
The study staff will ask questions about the participants health and illness (eg any confirmed influenza infections during the study period).
Intervention code [1] 313284 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 318608 0
Antibody titres following seasonal influenza vaccination using serum assays.

Timepoint [1] 318608 0
Baseline and 21 days post vaccination
Primary outcome [2] 318802 0
Proportion achieving seroprotective titres (where a correlate of protection exists) following seasonal influenza vaccination using serum assays.
Timepoint [2] 318802 0
baseline and 21 days post vaccination
Secondary outcome [1] 365522 0
Nil
Timepoint [1] 365522 0
Nil

Eligibility
Key inclusion criteria
• Be healthy males or females, aged between 6 months and 9 years at the time of providing informed consent.
• Plan to be vaccinated with the seasonal Southern Hemisphere formulation of the Inactivated Influenza vaccine
• Have a parent able and willing to provide written informed consent for themselves and child.
• Able to understand, and willing and physically able to comply with study procedures.
• Be able to provide a sample of up to 3mL of venous blood pre-vaccination without undue distress/discomfort.
Minimum age
6 Months
Maximum age
9 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Child has received any licensed or investigational vaccine or receiving any investigational product in the 28 days prior to taking Visit 1 blood sample;
• Child has a confirmed or suspected immunosupporessive condition (including cancer), or a previously diagnosed (congenital or acquired) immunodeficiency disorder including human immunodeficiency virus (HIV) infection at the time of study enrolment;
• Child has undergone chemotherapy or radiotherapy in the last 6 months at the time of study enrolment.
• The child currently (or within the last 90 days prior to blood collection) taking immunosuppressive or immunodulative medication, including systemic corticosteroids. Use of topical, inhalant or intra-articular corticosteroids is permitted prior to the study and during the on study period.
• Child has received immunoglobulin and/or blood product in the 28 days prior to taking Visit 1 blood sample.
• Parental or child participation in a clinical study that may interfere with participation in this study
• Anything that would place the individual at increased risk or preclude the individual’s full compliance with or completion of the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This study has not been designed to test any formal hypotheses. Descriptive statistics will be reported and will include Haemagluttination Inhibition Antibody titres, Geometrical Mean titres and pre-and post-vaccination Geometric Mean titre ratios.
Groups receiving 1 dose of the influenza vaccine will be tabulated separately to groups receiving 2 doses of the influenza vaccine.
The proportion of participants achieving seropositive antibody titres and demonstrating seroconversion post-vaccination will be reported.

Recruitment
Recruitment status
Not yet recruiting
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)
SA
Recruitment postcode(s) [1] 25322 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 301579 0
Other
Name [1] 301579 0
World Health Organisation
Address [1] 301579 0
World Health Organization (WHO)
Avenue Appia 20
1211 Geneva 27
Switzerland
Country [1] 301579 0
Switzerland
Primary sponsor type
Hospital
Name
Women's and Children's Health Network
Address
72 King William Road, North Adelaide SA 5006 Australia
Country
Australia
Secondary sponsor category [1] 301277 0
Other
Name [1] 301277 0
WHO Collaborating Centre for Reference and Research on Influenza (VIDRL) Peter Doherty Institute for Infection and Immunity
Address [1] 301277 0
792 Elizabeth Street, Melbourne. VIC 3000, Australia
Country [1] 301277 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302308 0
Women's and Children's Health Network Human Research Ethics Committee
Ethics committee address [1] 302308 0
72 King William Road, North Adelaide SA 5006 Australia
Ethics committee country [1] 302308 0
Australia
Date submitted for ethics approval [1] 302308 0
01/08/2018
Approval date [1] 302308 0
28/08/2018
Ethics approval number [1] 302308 0
HREC/18/WCHN/62

Summary
Brief summary
A total of 40 children (aged between 6 months and 9 years of age) will be enrolled into this research study. After written and informed parental consent, a 3ml blood sample will be collected to determine the baseline anti-haemagglutination antibody titre. The participant will then be administered the Southern Hemisphere Licensed Quadrivalent Seasonal Influenza vaccine according to the Australian Immunisation Handbook (AIH) guidlines. At the last visit, a second 3ml blood sample will be collected for the determination of post-vaccination antibody titres.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89774 0
Prof Helen Marshall
Address 89774 0
Women's and Children's Hospital, North Adelaide, 5006, SA
Country 89774 0
Australia
Phone 89774 0
+61 08 8161 8115
Fax 89774 0
+61 08 8161 7031
Email 89774 0
helen.marshall@adelaide.edu.au
Contact person for public queries
Name 89775 0
Miss Kathryn Riley
Address 89775 0
Vaccinology and Immunology Research Trials Unit
72 King William Road, North Adelaide, SA 5006 AUSTRALIA
Country 89775 0
Australia
Phone 89775 0
+61 8 8161 6328
Fax 89775 0
+61 08 8161 7031
Email 89775 0
kathryn.riley@adelaide.edu.au
Contact person for scientific queries
Name 89776 0
Miss Kathryn Riley
Address 89776 0
Vaccinology and Immunology Research Trials Unit72 King William Road, North Adelaide, SA 5006 AUSTRALIA
Country 89776 0
Australia
Phone 89776 0
+61 8 8161 6328
Fax 89776 0
+61 08 8161 7031
Email 89776 0
kathryn.riley@adelaide.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant confidentiality is strictly held in trust by the participating investigators, immunisation providers and SA Health Immunisation Section. This confidentiality is extended to cover testing of biological samples in addition to the clinical information relating to participants.
Study participant research data, which is for purposes of statistical analysis and scientific reporting, may be shared externally for purposes related to this study (ie biostatisticians/external researchers involved with this study). This will not include the participant’s contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number.
What supporting documents are/will be available?
No other documents available
Summary results
No Results