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Trial registered on ANZCTR


Registration number
ACTRN12619000792123
Ethics application status
Approved
Date submitted
10/05/2019
Date registered
29/05/2019
Date last updated
29/05/2019
Date data sharing statement initially provided
29/05/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Reactogenicity Study of Afluria Quad/Afluria Quad Junior in Children
Scientific title
A Phase IIIb-IV, Multicentre, Randomised, Open-label Study to Characterise the Reactogenicity of Afluria Quad Junior in Children 6 Months to Less Than 3 Years, and Afluria Quad in Children 3 Years to Less Than 9 Years Across Three Influenza Seasons
Secondary ID [1] 298113 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza, Humans 312644 0
Condition category
Condition code
Infection 311138 311138 0 0
Other infectious diseases
Public Health 311319 311319 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Afluria Quad/Afluria Quad Junior

Afluria Quad/Afluria Quad Junior is an inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as either one or two intramuscular dose(s) depending on their previous history of influenza virus vaccination according to age appropriate national vaccine administration recommendations outlined in the Australian or New Zealand Immunisation Handbooks. Participants with previous history of influenza virus vaccination will receive 1 dose; and participants 6 months to <9 years receiving an influenza vaccine for the first time will receive 2 doses.

In each vaccination season, participants 6 months to less than 3 years will be randomly
administered one of three manufacturing batches of Afluria Quad Junior, and participants 3 years to less than 9 years will be randomly administered one of three manufacturing batches of Afluria Quad vaccine. Participants will receive the following dose depending upon their age at the time of administration of the first dose of Study Vaccine:
- 6 months to less than 3 years of age: 1 or 2 doses of 7.5 mcg hemagglutinin antigen
- 3 years to less than 9 years of age: 1 or 2 doses of 15 mcg hemagglutinin antigen


Intervention code [1] 314338 0
Prevention
Comparator / control treatment
This study is a randomized open label, uncontrolled study of Seqirus split-virion quadrivalent inactivated influenza virus vaccine (Afluria Quad and Afluria Quad Junior)

In each vaccination season, participants 6 months to less than 3 years will be randomly administered 1 of 3 manufacturing batches of Afluria Quad Junior vaccine, and participants 3 years to less than 9 years will be randomly administered 1 of 3 manufacturing batches of Afluria Quad vaccine.

The 3 distinct batches will be randomly allocated and compared over 3 seasons (9 batches in total).

The reactogenicity of the vaccine will be assessed across the 3 batches and descriptive comparative analyses of the 3 batches will be conducted each year within season and at the end of the 3 seasons overall across the 9 batches.
Control group
Active

Outcomes
Primary outcome [1] 319911 0
Frequency, intensity and duration of solicited local adverse reactions (composite primary outcome measure).

Examples of solicited local adverse reactions: Pain at the vaccination site, erythema at the vaccination site, induration/swelling at the vaccination site

Solicited adverse reactions are derived from organised data collection systems, such as Subject eDiaries or interview
Timepoint [1] 319911 0
Up to 7 days after each vaccination
Primary outcome [2] 319912 0
Frequency, intensity and duration of solicited systemic reactions (composite primary outcome measure)

Examples of solicited systemic reactions: Fever, diarrhea, ‘nausea and/or vomiting,

Solicited adverse reactions are derived from organised data collection systems, such as Subject eDiaries or interview


Timepoint [2] 319912 0
Up to 7 days after each vaccination
Secondary outcome [1] 369842 0
Frequency of SAEs occurring after any administration of Afluria Quad/Afluria Quad Junior

AEs will be monitored after any vaccination to assess the frequency of SAEs occurring up to 7 days after any administration of Afluria Quad/Afluria Quad Junior. All SAEs will be evaluated by the investigator for relationship of the event to Study Vaccine. Events will captured at Visit 2 or the Day 8+3 follow-up phone call.

Timepoint [1] 369842 0
Up to 7 days after vaccination

Eligibility
Key inclusion criteria
1. Male or female subjects 6 months to less than 9 years of age at the time of planned first vaccination in a given season;
2. Subjects whose parent(s)/guardian(s) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry and are willing and able to adhere to all protocol requirements.
Minimum age
6 Months
Maximum age
8 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of severe allergic reactions (eg, anaphylaxis) to any component of the Study
Vaccine or to a previous dose of any influenza vaccine.
2.Participant has received a licensed or investigational influenza vaccine in the 6 month period prior to enrolment.
3. Family members of the employees of the Investigator or study centre with direct involvement in the study, or with other clinical studies under the direction of that Investigator or study centre.
4. Any other condition that per the opinion of the investigator may adversely impact the subject through participation in the study.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
After stratification by age, participants will be randomised at the participant level to be vaccinated for each indicated dose with one of three different vaccine batches, using a 1:1:1 allocation. In each vaccination season, participants 6 months to less than 3 years will be randomly administered one of three Afluria Quad Junior vaccine batches, and participants 3 years to less than 9 years will be randomly administered one of three Afluria Quad vaccine batches.

Afluria Quad/Afluria Quad will be administered as either one or two intramuscular dose(s) depending on their previous history of influenza virus vaccination according to age appropriate national vaccine administration recommendations outlined in the Australian or New Zealand Immunisation Handbooks. Participants will receive the following dose depending upon their age at the time of administration of the first dose of Study Vaccine:
- 6 months to less than 3 years of age: 1 or 2 doses of 7.5 mcg hemagglutinin antigen
- 3 years to less than 9 years of age: 1 or 2 doses of 15 mcg hemagglutinin antigen
Phase
Phase 3 / Phase 4
Type of endpoint(s)
Safety
Statistical methods / analysis

Recruitment
Recruitment status
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)
NSW,QLD,VIC
Recruitment outside Australia
Country [1] 21444 0
New Zealand
State/province [1] 21444 0
Rotorua, Christchurch, Auckland

Funding & Sponsors
Funding source category [1] 302644 0
Commercial sector/Industry
Name [1] 302644 0
Seqirus
Address [1] 302644 0
Level 3, 29 Market Street
Maidenhead SL6 8AA
Country [1] 302644 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Seqirus
Address
Level 3, 29 Market Street
Maidenhead SL6 8AA
Country
United Kingdom
Secondary sponsor category [1] 302560 0
Commercial sector/Industry
Name [1] 302560 0
INC Research Australia Pty Limited, a Syneos Health Group Company
Address [1] 302560 0
159 Port Rd Hindmarsh, SA 5007 Australia
Country [1] 302560 0
Australia
Secondary sponsor category [2] 302561 0
Commercial sector/Industry
Name [2] 302561 0
INC Research New Zealand Limited, a Syneos Health Group Company
Address [2] 302561 0
Unit G-1, 14-22 Triton Drive, Rosedale, Auckland 0632 New Zealand
Country [2] 302561 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303269 0
Bellberry Human Research Ethics Committees
Ethics committee address [1] 303269 0
123 Glen Osmond Road
Eastwood Adelaide
South Australia 5063
Ethics committee country [1] 303269 0
Australia
Date submitted for ethics approval [1] 303269 0
Approval date [1] 303269 0
16/04/2019
Ethics approval number [1] 303269 0

Summary
Brief summary
This is a safety study of quadrivalent inactivated influenza virus vaccine, Afluria Quad and Afluria Quad Junior, conducted over three Southern Hemisphere vaccination seasons to provide ongoing characterisation of the reactogenicity profile of Afluria Quad in the clinical and public health environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93082 0
Dr Terry Nolan
Address 93082 0
School of Population and Global Health
207 Bouverie Street
The University of Melbourne, VIC, 3010
Country 93082 0
Australia
Phone 93082 0
+61 3 8344 9350
Fax 93082 0
Email 93082 0
t.nolan@unimelb.edu.au
Contact person for public queries
Name 93083 0
Ms Khushboo Belani
Address 93083 0
Seqirus
25 Deforest Ave
Summit, NJ 07901
USA
Country 93083 0
United States of America
Phone 93083 0
+1855-358-8966
Fax 93083 0
Email 93083 0
seqirus.clinicaltrials@seqirus.com
Contact person for scientific queries
Name 93084 0
Ms Khushboo Belani
Address 93084 0
Seqirus
25 Deforest Ave
Summit, NJ 07901
USA
Country 93084 0
United States of America
Phone 93084 0
+1855-358-8966
Fax 93084 0
Email 93084 0
seqirus.clinicaltrials@seqirus.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results