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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03932682
Ethics application status
Date submitted
22/04/2019
Date registered
1/05/2019

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
Treatment: Other - QIVc
Treatment: Other - Comparator

Experimental: QIVc - Cell-derived Quadrivalent Influenza Vaccine

Active comparator: Comparator - Non-influenza Comparator


Treatment: Other: 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.

Treatment: Other: Comparator
Meningococcal Group C Polysaccharide Conjugate Vaccine (NeisVac-C)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Efficacy Endpoint: First Occurrence of Reverse Transcription-polymerase Chain Reaction (RT-PCR) Confirmed Influenza, Due to Any Influenza Type A and/or B Virus Regardless of Antigenic Match
Timepoint [1] 0 0
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
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
Timepoint [2] 0 0
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
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
Timepoint [1] 0 0
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
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
Timepoint [2] 0 0
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
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
Timepoint [3] 0 0
>14 days after last vaccination in the treatment period up to Day 181 or end of influenza season, whichever was longer (previously vaccinated subjects), or up to Day 209 or end of influenza season, whichever was longer (not previously vaccinated subjects)
Secondary outcome [4] 0 0
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
Timepoint [4] 0 0
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Secondary outcome [5] 0 0
Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
Timepoint [5] 0 0
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Secondary outcome [6] 0 0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
Timepoint [6] 0 0
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Secondary outcome [7] 0 0
Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
Timepoint [7] 0 0
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Secondary outcome [8] 0 0
Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
Timepoint [8] 0 0
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Secondary outcome [9] 0 0
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
Timepoint [9] 0 0
Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
Secondary outcome [10] 0 0
Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Timepoint [10] 0 0
7 days following each vaccination in the treatment period, ie, Day 1 to Day 7 for previously vaccinated subjects and Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects
Secondary outcome [11] 0 0
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Timepoint [11] 0 0
28 days after each vaccination in the treatment period, ie, Day 1 to Day 29 for previously vaccinated subjects and Day 1 to Day 57 for not previously vaccinated subjects
Secondary outcome [12] 0 0
Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
Timepoint [12] 0 0
Day 1 through Study Completion, ie, Day 1 to Day 181 or end of influenza season, whichever was longer, for previously vaccinated subjects and Day 1 to Day 209 or end of influenza season, whichever was longer, for not previously vaccinated subjects
Secondary outcome [13] 0 0
Safety Endpoint: Percentage of Subjects With Medically-attended AEs
Timepoint [13] 0 0
If a subject experienced an ILI during approximately 8 months of study participation, medically-attended AEs were collected for the 30-day period after onset of the ILI (defined as the first day that a subject meets the criteria for protocol-defined ILI)

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.

If applicable, 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
Sex
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 are provided in the study protocol.

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
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
13/05/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
13/02/2024
Sample size
Target
Accrual to date
Final
5723
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Bangladesh
State/province [1] 0 0
Dhaka
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Dobrich
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Montana
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Pleven
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Plovdiv
Country [6] 0 0
Bulgaria
State/province [6] 0 0
Ruse
Country [7] 0 0
Bulgaria
State/province [7] 0 0
Sevlievo
Country [8] 0 0
Czechia
State/province [8] 0 0
Chlumec Nad Cidlinou
Country [9] 0 0
Czechia
State/province [9] 0 0
Jindrichuv Hradec
Country [10] 0 0
Czechia
State/province [10] 0 0
Ostrava-poruba
Country [11] 0 0
Czechia
State/province [11] 0 0
Ostrava
Country [12] 0 0
Czechia
State/province [12] 0 0
Pardubice
Country [13] 0 0
Estonia
State/province [13] 0 0
Paide
Country [14] 0 0
Estonia
State/province [14] 0 0
Tallinn
Country [15] 0 0
Estonia
State/province [15] 0 0
Tallin
Country [16] 0 0
Estonia
State/province [16] 0 0
Tartu
Country [17] 0 0
Honduras
State/province [17] 0 0
San Pedro Sula
Country [18] 0 0
Honduras
State/province [18] 0 0
Tegucigalpa
Country [19] 0 0
Latvia
State/province [19] 0 0
Daugavpils
Country [20] 0 0
Malaysia
State/province [20] 0 0
Perlis
Country [21] 0 0
Malaysia
State/province [21] 0 0
Sarawak
Country [22] 0 0
Malaysia
State/province [22] 0 0
Wilyah Persekutuan Putrajaya
Country [23] 0 0
Malaysia
State/province [23] 0 0
Kuala Lumpur
Country [24] 0 0
New Zealand
State/province [24] 0 0
Christchurch
Country [25] 0 0
New Zealand
State/province [25] 0 0
Wellington
Country [26] 0 0
Pakistan
State/province [26] 0 0
Islamabad
Country [27] 0 0
Pakistan
State/province [27] 0 0
Karachi
Country [28] 0 0
Pakistan
State/province [28] 0 0
Lahore
Country [29] 0 0
Pakistan
State/province [29] 0 0
Rawalpindi
Country [30] 0 0
Philippines
State/province [30] 0 0
Manila
Country [31] 0 0
Philippines
State/province [31] 0 0
Quezon
Country [32] 0 0
Philippines
State/province [32] 0 0
Bacoor
Country [33] 0 0
Philippines
State/province [33] 0 0
Cebu City
Country [34] 0 0
Philippines
State/province [34] 0 0
Dasmariñas
Country [35] 0 0
Philippines
State/province [35] 0 0
Quezon City
Country [36] 0 0
Poland
State/province [36] 0 0
Bydgoszcz
Country [37] 0 0
Poland
State/province [37] 0 0
Debica
Country [38] 0 0
Poland
State/province [38] 0 0
Gdansk
Country [39] 0 0
Poland
State/province [39] 0 0
Kraków
Country [40] 0 0
Poland
State/province [40] 0 0
Rzeszów
Country [41] 0 0
Poland
State/province [41] 0 0
Siemianowice Slaskie
Country [42] 0 0
Poland
State/province [42] 0 0
Skierniewice
Country [43] 0 0
Poland
State/province [43] 0 0
Trzebnica
Country [44] 0 0
Romania
State/province [44] 0 0
Bucuresti
Country [45] 0 0
Romania
State/province [45] 0 0
Caracal
Country [46] 0 0
Romania
State/province [46] 0 0
Calarasi
Country [47] 0 0
Romania
State/province [47] 0 0
Sângeorgiu De Mures
Country [48] 0 0
South Africa
State/province [48] 0 0
Brits
Country [49] 0 0
South Africa
State/province [49] 0 0
Cape Town
Country [50] 0 0
South Africa
State/province [50] 0 0
East London
Country [51] 0 0
South Africa
State/province [51] 0 0
Klerksdorp
Country [52] 0 0
South Africa
State/province [52] 0 0
Paarl
Country [53] 0 0
South Africa
State/province [53] 0 0
Pretoria
Country [54] 0 0
South Africa
State/province [54] 0 0
Soweto
Country [55] 0 0
South Africa
State/province [55] 0 0
Thabazimbi
Country [56] 0 0
Thailand
State/province [56] 0 0
Bangkok
Country [57] 0 0
Ukraine
State/province [57] 0 0
Chernivtsi
Country [58] 0 0
Ukraine
State/province [58] 0 0
Dnipro
Country [59] 0 0
Ukraine
State/province [59] 0 0
Vinnytsia

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement


What supporting documents are/will be available?

TypeOther DetailsAttachment
Study protocol
Statistical analysis plan



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT03932682