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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03932682




Registration number
NCT03932682
Ethics application status
Date submitted
22/04/2019
Date registered
1/05/2019
Date last updated
20/06/2019

Titles & IDs
Public title
Efficacy Study With QIVc in Pediatric Subjects
Scientific title
A Phase 3, Randomized, Observer-blind, Multicenter Study to Evaluate the Efficacy, Immunogenicity and Safety of Seqirus' Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) Compared to a Non-Influenza Vaccine When Administrated in Healthy Subjects Aged 6 Months Through 47 Months
Secondary ID [1] 0 0
2018-001857-29
Secondary ID [2] 0 0
V130_14
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - QIVc
Other interventions - Comparator

Experimental: Seqirus QIVc - Cell-derived Quadrivalent Influenza Vaccine

Active Comparator: Comparator - Non-influenza Comparator (NesiVac-C)


Other interventions: QIVc
QIVc is a quadrivalent vaccine and contains 2 influenza type A strains and 2 influenza type B lineages recommended by World Health Organization (WHO) for inclusion in the quadrivalent vaccine formulation for the influenza season corresponding to the season of conduct of study.

Other interventions: Comparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (MenC vaccine, Neisvac-C)

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

Outcomes
Primary outcome [1] 0 0
Efficacy Endpoint: First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match - First occurrence of RT-PCR confirmed influenza, due to any influenza Type A and/or B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined influenza-like illness (ILI) symptoms
Timepoint [1] 0 0
Day 14 to Day 180
Primary outcome [2] 0 0
Efficacy Endpoint: First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine - First occurrence of culture confirmed influenza, due to influenza Type A and/or B virus antigenically matched by ferret antigenicity testing to the strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Timepoint [2] 0 0
Day 14 to Day 180
Secondary outcome [1] 0 0
Efficacy Endpoint: First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal influenza vaccine - First occurrence of culture confirmed influenza caused by influenza virus strains antigenically dissimilar to the influenza strains selected for the seasonal vaccine occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Timepoint [1] 0 0
Day 14 to Day 180
Secondary outcome [2] 0 0
Efficacy Endpoint: First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine - First occurrence of culture confirmed influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season, in association with protocol-defined ILI symptoms
Timepoint [2] 0 0
Day 14 to Day 180
Secondary outcome [3] 0 0
Efficacy Endpoint: First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine - First occurrence of RT-PCR confirmed moderate-to-severe influenza due to any influenza Type A and/or Type B virus regardless of antigenic match to the influenza strains selected for the seasonal influenza vaccine, occurring at >14 days after the last vaccination and until the end of the influenza season
Timepoint [3] 0 0
Day 14 to Day 180
Secondary outcome [4] 0 0
Immunogenicity Endpoint: a) Prevaccination and postvaccination Geometric Mean Titer (GMT) - The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a microneutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
Timepoint [4] 0 0
Day 1 and 28 days after last vaccination
Secondary outcome [5] 0 0
Immunogenicity Endpoint: Seroconversion rates (SCR) - The measures for immunogenicity are determined by a HI and/or a MN assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
SCR is defined as the percentage of subjects with either a prevaccination HI (or MN) titer < 1:10 and a postvaccination HI (or MN) titer = 1:40, or a prevaccination HI (or MN) titer = 1:10 and a = 4-fold increase in postvaccination HI (or MN) titer
Timepoint [5] 0 0
Day 1 and 28 days after last vaccination
Secondary outcome [6] 0 0
Immunogenicity endpoint: Geometric Mean Ratio (GMR) - The measures for immunogenicity are determined by a haemagglutination inhibition [HI] and/or a micro neutralization [MN] assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
GMR is the geometric mean of the fold increase of post-vaccination HI (or MN) titer over the pre-vaccination HI (or MN) titer
Timepoint [6] 0 0
Day 1 and 28 days after last vaccination
Secondary outcome [7] 0 0
Safety Endpoint: Percentage of subjects with solicited local and systemic adverse events (AE) - Percentage of subjects with solicited local and systemic AEs will be assessed for 7 days following each vaccination in the QIVc group and in the comparator group
Timepoint [7] 0 0
7 days following each vaccination
Secondary outcome [8] 0 0
Safety Endpoint: Percentage of subjects with unsolicited AEs - Percentage of subjects with any unsolicited AEs will be assessed in the QIVc group and in the comparator group until 28 days after each vaccination
Timepoint [8] 0 0
28 days following each vaccination
Secondary outcome [9] 0 0
Safety Endpoint: Percentage of subjects with SAEs, NOCDs, AEs leading to withdrawal from the study or vaccination - Percentage of subjects with serious AEs (SAE), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events will be reported in the QIVc group and in the comparator group
Timepoint [9] 0 0
Day 1 to Day 180
Secondary outcome [10] 0 0
Safety Endpoint: Percentage of subjects with medically-attended AEs - Percentage of subjects with medically-attended AEs within 30 days after ILI onset will be reported in the QIVc group and in the comparator group
Timepoint [10] 0 0
30 days following ILI onset

Eligibility
Key inclusion criteria
In order to participate in this study, all subjects must meet all of the inclusion criteria
described.

- Individuals of 6 through 47 months of age on the day of informed consent.

- Individuals whose parent(s)/Legally Acceptable Representative(LAR) have voluntarily
given written informed consent after the nature of the study has been explained
according to local regulatory requirements, prior to study entry.

- Individuals who can comply with study procedures including follow-up .

- Individuals in generally good health as per the Investigator's medical judgement.

Prior to receipt of second study vaccination, subjects must be evaluated to confirm that
they are eligible for subsequent vaccination. If subjects do not meet the criteria of the
original inclusion criteria listed above, they should not receive additional vaccinations.
Minimum age
6 Months
Maximum age
47 Months
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Acute (severe) febrile illness. Enrollment could be considered if the fever is absent
for 72 hours.

- History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including
allergic reactions, to any component of vaccine or medical equipment whose use is
foreseen in this study.

- Clinical conditions representing a contraindication to intramuscular vaccination and
blood draws. These may include known bleeding disorders, or treatment with
anticoagulants in the 3 weeks preceding vaccination.

- A known history of Guillain-Barré Syndrome or other demyelinating diseases such as
encephalomyelitis and transverse myelitis.

- Abnormal function of the immune system resulting from a clinical condition

- Received influenza vaccination or has had documented influenza disease in the last 6
months prior to informed consent.

- Prior vaccination to prevent Neisseria meningitides serogroup C disease or prior
infection caused by this organism.

Additional eligibility criteria may be discussed by contacting the site.

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 administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
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 outside Australia
Country [1] 0 0
Honduras
State/province [1] 0 0
San Pedro Sula
Country [2] 0 0
Honduras
State/province [2] 0 0
Tegucigalpa
Country [3] 0 0
Malaysia
State/province [3] 0 0
Perlis
Country [4] 0 0
Malaysia
State/province [4] 0 0
Sarawak
Country [5] 0 0
Malaysia
State/province [5] 0 0
Wilyah Persekutuan Putrajaya
Country [6] 0 0
Malaysia
State/province [6] 0 0
Kuala Lumpur
Country [7] 0 0
New Zealand
State/province [7] 0 0
Christchurch
Country [8] 0 0
New Zealand
State/province [8] 0 0
Wellington
Country [9] 0 0
Philippines
State/province [9] 0 0
Manila
Country [10] 0 0
Philippines
State/province [10] 0 0
Alabang
Country [11] 0 0
Philippines
State/province [11] 0 0
Laguna
Country [12] 0 0
Philippines
State/province [12] 0 0
Quezon
Country [13] 0 0
Thailand
State/province [13] 0 0
Bangkok

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

Ethics approval
Ethics application status

Summary
Brief summary
This phase 3 clinical study is a randomized, observer-blind, multicenter study of QIVc versus
a non-influenza vaccine in subjects 6 months though 47 months of age. The purpose of this
study is to evaluate efficacy of QIVc in the prevention of Reverse transcription polymerase
chain reaction (RT-PCR) confirmed influenza A or B disease in children 6 through 47 months of
age, compared to a non-influenza vaccine.
Trial website
https://clinicaltrials.gov/show/NCT03932682
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Program Director
Address 0 0
Seqirus
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