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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
Date last updated
25/03/2025
Titles & IDs
Public title
Efficacy Study With QIVc in Pediatric Subjects
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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
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Secondary ID [1]
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2018-001857-29
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Secondary ID [2]
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V130_14
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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, Human
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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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)
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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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
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Assessment method [1]
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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
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Timepoint [1]
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>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)
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Primary outcome [2]
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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
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Assessment method [2]
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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
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Timepoint [2]
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>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)
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Secondary outcome [1]
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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
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Assessment method [1]
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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
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Timepoint [1]
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>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)
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Secondary outcome [2]
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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
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Assessment method [2]
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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
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Timepoint [2]
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>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)
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Secondary outcome [3]
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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
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Assessment method [3]
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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
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Timepoint [3]
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>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)
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Secondary outcome [4]
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Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (HI Assay)
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Assessment method [4]
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The measures for immunogenicity are determined by a hemagglutination inhibition (HI) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains HI = hemagglutination inhibition Adjusted GMTs are presented
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Timepoint [4]
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Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
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Secondary outcome [5]
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Immunogenicity Endpoint: Seroconversion Rates (SCR) (HI Assay)
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Assessment method [5]
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The measures for immunogenicity are determined by a HI 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 titer \<1:10 and a postvaccination HI titer =1:40, or a prevaccination HI titer =1:10 and a =4-fold increase in postvaccination HI titer
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Timepoint [5]
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Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
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Secondary outcome [6]
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Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (HI Assay)
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Assessment method [6]
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The measures for immunogenicity are determined by a hemagglutination inhibition (HI) 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 postvaccination HI titer over the prevaccination HI titer Adjusted GMRs are presented
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Timepoint [6]
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Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
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Secondary outcome [7]
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Immunogenicity Endpoint: Prevaccination and Postvaccination Geometric Mean Titer (GMT) (MN Assay)
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Assessment method [7]
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The measures for immunogenicity are determined by a microneutralization (MN) assay prior to first vaccination and 28 days after last vaccination for all four influenza strains
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Timepoint [7]
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Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
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Secondary outcome [8]
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Immunogenicity Endpoint: Seroconversion Rates (SCR) (MN Assay)
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Assessment method [8]
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The measures for immunogenicity are determined by 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 MN titer \<1:10 and a postvaccination MN titer =1:40, or a prevaccination MN titer =1:10 and a =4-fold increase in postvaccination MN titer
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Timepoint [8]
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Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
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Secondary outcome [9]
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Immunogenicity Endpoint: Geometric Mean Ratio (GMR) (MN Assay)
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Assessment method [9]
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The measures for immunogenicity are determined by a 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 MN titer over the pre-vaccination MN titer
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Timepoint [9]
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Day 1 through Day 29 for previously vaccinated subjects; Day 1 through Day 57 for not previously vaccinated subjects
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Secondary outcome [10]
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Safety Endpoint: Percentage of Subjects With Solicited Local and Systemic Adverse Events (AEs)
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Assessment method [10]
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Percentage of subjects with solicited local and systemic AEs assessed for 7 days following each vaccination in the QIVc group and in the comparator group
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Timepoint [10]
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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
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Secondary outcome [11]
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Safety Endpoint: Percentage of Subjects With Unsolicited AEs
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Assessment method [11]
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Percentage of subjects with any unsolicited AEs assessed in the QIVc group and in the comparator group until 28 days after each vaccination
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Timepoint [11]
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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
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Secondary outcome [12]
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Safety Endpoint: Percentage of Subjects With SAEs, NOCDs, AEs Leading to Withdrawal From the Study or Vaccination
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Assessment method [12]
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Percentage of subjects with serious adverse events (SAEs), new onset of chronic disease (NOCD), AEs leading to withdrawal from the study or vaccination, and all medications associated with these events in the QIVc group and in the comparator group Note: The time frame for assessment of these AEs was Day 1 through Study Completion as indicated below. Subjects aged 6 months through 11 months at enrollment in countries without NeisVac-C vaccine marketing authorization had an additional study visit 28 days later (ie, Day 237).
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Timepoint [12]
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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
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Secondary outcome [13]
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Safety Endpoint: Percentage of Subjects With Medically-attended AEs
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Assessment method [13]
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Percentage of subjects with medically-attended AEs within 30 days after ILI onset in the QIVc group and in the comparator group
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Timepoint [13]
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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)
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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.
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Minimum age
6
Months
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Maximum age
47
Months
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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
* 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.
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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
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/05/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
13/02/2024
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Sample size
Target
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Accrual to date
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Final
5723
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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Bangladesh
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Dhaka
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Bulgaria
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Dobrich
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Bulgaria
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Montana
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Bulgaria
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Pleven
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Bulgaria
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Plovdiv
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Bulgaria
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Ruse
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Bulgaria
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Sevlievo
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Czechia
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Chlumec Nad Cidlinou
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Czechia
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Jindrichuv Hradec
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Ostrava-poruba
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Ostrava
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Czechia
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Pardubice
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Estonia
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Paide
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Estonia
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Tallinn
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Estonia
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Tallin
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Estonia
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Tartu
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Honduras
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San Pedro Sula
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Honduras
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Tegucigalpa
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Latvia
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Daugavpils
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Perlis
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Malaysia
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Sarawak
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Malaysia
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Wilyah Persekutuan Putrajaya
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Malaysia
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Kuala Lumpur
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Christchurch
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Wellington
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Pakistan
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Islamabad
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Pakistan
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Karachi
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Pakistan
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Lahore
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Pakistan
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Rawalpindi
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Philippines
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Manila
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Philippines
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Quezon
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Philippines
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Bacoor
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Philippines
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Philippines
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Quezon City
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Poland
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Bydgoszcz
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Debica
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Gdansk
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Kraków
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Rzeszów
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Romania
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Bucuresti
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Caracal
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Calarasi
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Romania
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Sângeorgiu De Mures
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South Africa
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Brits
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Cape Town
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South Africa
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East London
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South Africa
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Paarl
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Pretoria
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South Africa
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Soweto
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South Africa
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Thabazimbi
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Thailand
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Bangkok
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Ukraine
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Chernivtsi
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Ukraine
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Dnipro
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Ukraine
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Vinnytsia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Seqirus
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Address
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Ethics approval
Ethics application status
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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 laboratory confirmed influenza A or B disease in children 6 through 47 months of age, compared to a non-influenza vaccine.
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Trial website
https://clinicaltrials.gov/study/NCT03932682
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Program Director
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Address
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Seqirus
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Fax
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Contact person for public queries
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Seqirus will consider on a case-by-case basis requests to share Individual Patient Data (IPD) with external bona-fide, qualified scientific and medical researchers. For information on the process and requirements for submitting a voluntary data sharing request for IPD, please contact Seqirus at
[email protected]
.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
Requests for IPD will generally be considered once review by major regulatory authorities (ie FDA, EMA) is complete and the primary publication is available.
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Available to whom?
Proposed research should seek to answer a previously unanswered important medical or scientific question.
Applicable country specific privacy and other laws and regulations will be considered and may prevent sharing of IPD.
If the request is approved and the researcher has executed an appropriate data sharing agreement, IPD that has been appropriately anonymized will be available.
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Available for what types of analyses?
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How or where can data be obtained?
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/82/NCT03932682/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/82/NCT03932682/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03932682
Download to PDF