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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03165617




Registration number
NCT03165617
Ethics application status
Date submitted
17/05/2017
Date registered
24/05/2017

Titles & IDs
Public title
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects =2 to <18 Years of Age
Scientific title
A Phase III/IV, Stratified, Randomized, Observer Blind, Multicenter Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Influenza Comparator Vaccine in Subjects =2 to <18 Years of Age
Secondary ID [1] 0 0
2016-002883-15
Secondary ID [2] 0 0
V130_12
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 - Non-influenza Comparator Vaccine

Experimental: QIVc (=2 years to <18 Years of Age) - Cell-derived Seasonal Quadrivalent Influenza Vaccine

Active comparator: Non-Influenza Comparator Vaccine - Non-Influenza Comparator Vaccine


Treatment: Other: QIVc
Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains

Treatment: Other: Non-influenza Comparator Vaccine
Non-influenza comparator vaccine for intramuscular use
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Primary Efficacy: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects =2 to <18 Years
Timepoint [1] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer
Primary outcome [2] 0 0
Co-Primary: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza (Time-to-event Analyses) Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine in Subjects =3 to <18 Years
Timepoint [2] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer
Secondary outcome [1] 0 0
Secondary Efficacy #1: First Occurrence of Either RT-PCR- or Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Timepoint [1] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Secondary outcome [2] 0 0
Secondary Efficacy #2: First Occurrence of RT-PCR-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Timepoint [2] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Secondary outcome [3] 0 0
Secondary Efficacy #3: First Occurrence of Culture-confirmed Influenza Due to Any Influenza Type A or B Strain Regardless of Antigenic Match to the Strains Selected for the Seasonal Vaccine
Timepoint [3] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Secondary outcome [4] 0 0
Secondary Efficacy #4: First Occurrence of Culture-confirmed Influenza Due to Influenza Type A or B Strain Antigenically Matched to the Strains Selected for the Seasonal Vaccine
Timepoint [4] 0 0
Day 14 to Day 180 or until the end of the influenza season, whichever is longer.
Secondary outcome [5] 0 0
Secondary Immunogenicity: Geometric Mean Titers for 4 Influenza Strains (HI Assay)
Timepoint [5] 0 0
Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects receiving 2 doses)
Secondary outcome [6] 0 0
ISecondary Immunogenicity: Percentage of Subjects Achieving Seroconversion for 4 Influenza Strains (HI Assay)
Timepoint [6] 0 0
Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects)
Secondary outcome [7] 0 0
Secondary Immunogenicity: Geometric Mean Ratio for 4 Influenza Strains (HI Assay)
Timepoint [7] 0 0
Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects receiving 2 doses)
Secondary outcome [8] 0 0
Secondary Immunogenicity: Percentage of Subjects With HI Titer =1:40 for All 4 Influenza Strains (HI Assay)
Timepoint [8] 0 0
Day 1 (all subjects), Day 22 (all "previously vaccinated" subjects receiving a single vaccine dose) or Days 29 and 50 (all "not previously vaccinated"subjects receiving 2 doses)
Secondary outcome [9] 0 0
Safety: Percentage of Subjects With Solicited Local and Systemic Adverse Events for 7 Days After Vaccination
Timepoint [9] 0 0
days after vaccination on Day 1 (for "previously vaccinated" subjects) or for 7 days after vaccination on Day 1 and Day 29 (for "not previously vaccinated" subjects)
Secondary outcome [10] 0 0
Safety: Percentage of Subjects With Unsolicited AEs for 21 Days After Vaccination
Timepoint [10] 0 0
Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects)
Secondary outcome [11] 0 0
Safety: Subjects With SAEs, AEs Leading to Withdrawal From Vaccination and/or the Study,(MAAEs) Within 30 Days of a 1st Occurrence, Post-ILI, and NOCDs Reported During Entire Study Participation or End of Flue Season, Whichever Was Longer
Timepoint [11] 0 0
Day 1 to Day 181 (for previously vaccinated subjects) or to Day 209 (for not previously vaccinated subjects)

Eligibility
Key inclusion criteria
* Male or female =2 to <18 years of age on the day of the first study vaccination
* Subject's parent(s) or legal guardian(s) who was/were able to give informed consent/dissent after the nature of the study had been explained in accordance with the practices described in the study and according to local regulatory requirements
* If the subject was of an age where, according to local regulations, informed assent was required, he/she must have provided assent to participate in the study
* Subject/subject's parent(s) or legal guardian(s) was/were able to comply with study procedures and was/were available for follow-up; and
* Subject was in generally good health as per the investigator's medical judgment
Minimum age
2 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Clinical signs of fever and/or an oral temperature of =100.4°F (38.0°C) within 3 days prior to vaccination;
* A known history of any anaphylaxis, serious vaccine reactions or hypersensitivity to any of the vaccine components described in the Investigator's Brochure, or had any of the contraindications listed in the package insert of the comparator vaccine;
* A history of Guillain-Barré syndrome or other de-myelinating diseases such as encephalomyelitis and transverse myelitis;
* Female subject of childbearing potential (ie, post onset of menarche and before natural or induced menopause), sexually active, and who did not use any acceptable contraceptive methods for at least 2 months prior to study entry and who did not intend to use any acceptable contraceptive methods throughout subject participation (acceptable contraceptive methods included: abstinence; hormonal contraceptive [such as oral, injection, transdermal patch, implant]; diaphragm with spermicide; tubal occlusion device; intrauterine device [IUD]; tubal ligation; male partner using condom; or male partner having been vasectomized);
* Pregnant or breast feeding female;
* Subject and/or subject's parent/guardians who were not able to comprehend or follow all required study procedures for the entire period of the study;
* Received prior Meningococcal ACWY vaccination that conflicted with national recommendations or local practices for the timing of the primary or the booster vaccination;
* Received influenza vaccination or had documented influenza disease in the last 6 months;
* Known or suspected congenital or acquired immunodeficiency; or received immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or systemic corticosteroid therapy (prednisone or equivalent) at any dose for more than 2 consecutive weeks (14 days) within the past 3 months. Topical, inhaled and intra-nasal corticosteroids were permitted. Intermittent use (1 dose in 30 days) of intra-articular corticosteroids was also permitted;
* Administration of immunoglobulin and/or any blood products within the 3 months preceding vaccination, or administration was planned during the study;
* Participated in any clinical study with another investigational product within 30 days prior to first study visit or intended to participate in another clinical study at any time during the conduct of this study. Concomitant participation in an observational study (not involving drugs, vaccines, or medical devices) was acceptable;
* Medical conditions or treatments contraindicating IM vaccination due to increased risk of bleeding. These included known bleeding disorders (such as thrombocytopenia), or treatment with anticoagulants (such as warfarin) in the 3 weeks preceding vaccination. Antiplatelet agents such as low-dose aspirin, ticlopidine (Ticlid) and clopidogrel (Plavix) were permitted;
* Evidence or history (within the previous 12 months) of drug or alcohol abuse;
* Study personnel or immediate family members (brother, sister, child, parent), the spouse of study personnel or individuals who were financially or emotionally dependent on study staff;
* Participated in this study in a prior season, if applicable; or
* Any clinical condition that, in the opinion of the investigator, may have interfered with the results of the study or pose additional risk to the subject due to 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
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
25/05/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/09/2019
Sample size
Target
Accrual to date
Final
4514
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
302 AusTrials Pty Ltd - Sherwood
Recruitment hospital [2] 0 0
300 Murdoch Childrens Research Institute - Carlton
Recruitment postcode(s) [1] 0 0
4075 - Sherwood
Recruitment postcode(s) [2] 0 0
3010 - Carlton
Recruitment outside Australia
Country [1] 0 0
Estonia
State/province [1] 0 0
Harjumaa
Country [2] 0 0
Estonia
State/province [2] 0 0
Järvamaa
Country [3] 0 0
Estonia
State/province [3] 0 0
Tartumaa
Country [4] 0 0
Estonia
State/province [4] 0 0
Tartu
Country [5] 0 0
Finland
State/province [5] 0 0
Espoo
Country [6] 0 0
Finland
State/province [6] 0 0
Helsinki
Country [7] 0 0
Finland
State/province [7] 0 0
Järvenpää
Country [8] 0 0
Finland
State/province [8] 0 0
Kokkola
Country [9] 0 0
Finland
State/province [9] 0 0
Oulu
Country [10] 0 0
Finland
State/province [10] 0 0
Pori
Country [11] 0 0
Finland
State/province [11] 0 0
Seinäjoki
Country [12] 0 0
Finland
State/province [12] 0 0
Tampere
Country [13] 0 0
Finland
State/province [13] 0 0
Turku
Country [14] 0 0
Lithuania
State/province [14] 0 0
Alytus Apskritis
Country [15] 0 0
Lithuania
State/province [15] 0 0
Kauno Apskritis
Country [16] 0 0
Lithuania
State/province [16] 0 0
Kauno Apskrits
Country [17] 0 0
Lithuania
State/province [17] 0 0
Vilnaius Apskritis
Country [18] 0 0
Philippines
State/province [18] 0 0
Cavite
Country [19] 0 0
Philippines
State/province [19] 0 0
National Capital Region
Country [20] 0 0
Poland
State/province [20] 0 0
Dolnoslaskie
Country [21] 0 0
Poland
State/province [21] 0 0
Kujawsko-pomorskie
Country [22] 0 0
Poland
State/province [22] 0 0
Lubelskie
Country [23] 0 0
Poland
State/province [23] 0 0
Malopolskie
Country [24] 0 0
Poland
State/province [24] 0 0
Podkarpackie
Country [25] 0 0
Poland
State/province [25] 0 0
Slaskie
Country [26] 0 0
Spain
State/province [26] 0 0
A Coruña
Country [27] 0 0
Thailand
State/province [27] 0 0
Muang
Country [28] 0 0
Thailand
State/province [28] 0 0
Chiang Mai

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
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Seqirus supports the release of anonymized subject-level and study-level data in compliance with regulatory requirements, including Clinical Documents which are part of the CTD modules submitted to regulatory agencies for public release.

Summary results disclosure is either in document form (e.g., ICH E3 Clinical Study Report synopsis) or structured data form (such as summary results in ClinicalTrials.gov (United States) or eudract.ema.europa.eu (EU Clinical Trial Registry \[EU CTR\]).

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
Seqirus aims to disclose these results from clinical studies within twelve (12) months of the Study Completion unless otherwise mandated by local law or regulation.
Available to whom?
All requests will be fully vetted and data to be released approved, prior to distribution. Seqirus does not release subject-level data and study-level data if the requester's purpose is to conduct a re-analysis of the study data, as opposed to a meta-analysis.

While the URL link below does not outline the data sharing policy per se, it does present a high-level view of how the organization partners with external collaborators
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://www.seqirus.com/partnering


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03165617