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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
14/07/2023
Date data sharing statement initially provided
29/05/2019
Date results provided
14/07/2023
Type of registration
Retrospectively registered
Titles & IDs
Public title
Reactogenicity Study of Afluria Quad/Afluria Quad Junior in Children
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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
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Secondary ID [1]
298113
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None
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Influenza, Humans
312644
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Condition category
Condition code
Infection
311138
311138
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0
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Other infectious diseases
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Public Health
311319
311319
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0
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Other public health
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Afluria Quad/Afluria Quad Junior
Afluria Quad/Afluria Quad Junior is an inactivated, split-virion, 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
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Intervention code [1]
314338
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Prevention
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
319911
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Timepoint [1]
319911
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Up to 7 days after each vaccination
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Primary outcome [2]
319912
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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
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Assessment method [2]
319912
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Timepoint [2]
319912
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Up to 7 days after each vaccination
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Secondary outcome [1]
369842
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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.
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Assessment method [1]
369842
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Timepoint [1]
369842
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Up to 7 days after vaccination
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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.
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Minimum age
6
Months
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Maximum age
8
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
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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 Junior/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
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Phase
Phase 3 / Phase 4
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Type of endpoint/s
Safety
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
Data analysis is complete
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Reason for early stopping/withdrawal
Other reasons/comments
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Other reasons
Conduct of Season 3 was waived by TGA and Medsafe consequent to additional pediatric study data provided by the Sponsor supporting safe use of the vaccine in children.
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Date of first participant enrolment
Anticipated
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Actual
22/05/2019
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Date of last participant enrolment
Anticipated
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Actual
3/07/2020
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Date of last data collection
Anticipated
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Actual
11/08/2020
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Sample size
Target
1800
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Accrual to date
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Final
1056
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment outside Australia
Country [1]
21444
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New Zealand
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State/province [1]
21444
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Rotorua, Christchurch, Auckland
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Funding & Sponsors
Funding source category [1]
302644
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Commercial sector/Industry
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Name [1]
302644
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Seqirus
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Address [1]
302644
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Level 3, 29 Market Street
Maidenhead SL6 8AA
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Country [1]
302644
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United Kingdom
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Primary sponsor type
Commercial sector/Industry
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Name
Seqirus
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Address
Level 3, 29 Market Street
Maidenhead SL6 8AA
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Country
United Kingdom
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Secondary sponsor category [1]
302560
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Commercial sector/Industry
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Name [1]
302560
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INC Research Australia Pty Limited, a Syneos Health Group Company
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Address [1]
302560
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159 Port Rd Hindmarsh, SA 5007 Australia
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Country [1]
302560
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Australia
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Secondary sponsor category [2]
302561
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Commercial sector/Industry
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Name [2]
302561
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INC Research New Zealand Limited, a Syneos Health Group Company
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Address [2]
302561
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Unit G-1, 14-22 Triton Drive, Rosedale, Auckland 0632 New Zealand
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Country [2]
302561
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New Zealand
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
303269
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Bellberry Human Research Ethics Committees
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Ethics committee address [1]
303269
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123 Glen Osmond Road Eastwood Adelaide South Australia 5063
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Ethics committee country [1]
303269
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Australia
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Date submitted for ethics approval [1]
303269
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Approval date [1]
303269
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16/04/2019
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Ethics approval number [1]
303269
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
93082
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Dr Terry Nolan
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Address
93082
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School of Population and Global Health
207 Bouverie Street
The University of Melbourne, VIC, 3010
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Country
93082
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Australia
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Phone
93082
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+61 3 8344 9350
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Fax
93082
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Email
93082
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t.nolan@unimelb.edu.au
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Contact person for public queries
Name
93083
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Abhishek Shah
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Address
93083
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Seqirus
25 Deforest Ave
Summit, NJ 07901
USA
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Country
93083
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United States of America
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Phone
93083
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+17323972771
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Fax
93083
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Email
93083
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seqirus.clinicaltrials@seqirus.com
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Contact person for scientific queries
Name
93084
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Abhishek Shah
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Address
93084
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Seqirus
25 Deforest Ave
Summit, NJ 07901
USA
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Country
93084
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United States of America
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Phone
93084
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+17323972771
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Fax
93084
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Email
93084
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seqirus.clinicaltrials@seqirus.com
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
Type
Is Peer Reviewed?
DOI
Citations or Other Details
Attachment
Basic results
No
377506-(Uploaded-15-06-2023-02-42-46)-Basic results summary.docx
Documents added automatically
No additional documents have been identified.
Download to PDF