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Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of QIVc in Subjects ≥2 to ≤18 Years of Age

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ClinicalTrials.gov Identifier: NCT03165617
Recruitment Status : Active, not recruiting
First Posted : May 24, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The randomized, observer-blind non-influenza comparator controlled study is intended to demonstrate the efficacy, immunogenicity, safety and tolerability of Seqirus' cell-based inactivated quadrivalent vaccine (QIVc) in subjects ≥2 years to <18 years of age

Condition or disease Intervention/treatment Phase
Influenza, Human Biological: QIVc Biological: Non-influenza Comparator Vaccine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3314 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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
Actual Study Start Date : May 24, 2017
Estimated Primary Completion Date : March 17, 2019
Estimated Study Completion Date : March 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: QIVc (≥2 years to <18 Years of Age)
Cell-derived Seasonal Quadrivalent Influenza Vaccine
Biological: 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
Other Name: Flucelvax Quadrivalent
Active Comparator: Non-Influenza Comparator Vaccine
Non-Influenza Comparator Vaccine
Biological: Non-influenza Comparator Vaccine
Non-influenza comparator vaccine for intramuscular use


Outcome Measures

Primary Outcome Measures :
  1. Efficacy: Absolute vaccine efficacy of QIVc by first occurrence Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) or culture confirmed influenza, due to any influenza Type A and B strain in subjects ≥3 years to <18 years of age [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer ]
  2. Efficacy: Absolute vaccine efficacy of QIVc by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain in subjects ≥2 years to <18 years of age [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer ]

Secondary Outcome Measures :
  1. Efficacy: Absolute vaccine efficacy of QIVc by first occurrence RT-PCR or culture confirmed influenza, due to any influenza Type A and B strain by age subgroup [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer. ]
  2. Efficacy: Absolute vaccine efficacy of QIVc by first occurrence culture confirmed influenza, caused by influenza strains antigenically matched to the strains selected for the seasonal vaccine [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer. ]
  3. Efficacy: Absolute vaccine efficacy of QIVc determined by first occurrence RT-PCR influenza, due to any influenza Type A and B strain [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer. ]
  4. Efficacy: Absolute vaccine efficacy of QIVc determined by first occurrence culture confirmed influenza, due to any influenza Type A and B strain [ Time Frame: Day 14 to Day 180 or until the end of the influenza season, whichever is longer. ]
  5. Immunogenicity: Hemagglutination Inhibition (HI) Geometric mean titers (GMTs) [ Time Frame: Day 1 (all subjects), Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) ]
  6. Immunogenicity: Percentage of subjects achieving seroconversion (seroconversion rate) for all 4 influenza strains [ Time Frame: Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) ]
  7. Immunogenicity: HI Geometric Mean Ratio (GMR) [ Time Frame: Day 22/Day 1 (all previously vaccinated subjects) or Day 29/Day 1 and Day 50/Day 1 (all not previously vaccinated subjects) ]
  8. Immunogenicity: Percentage of subjects with HI titer ≥ 1:40 [ Time Frame: Day 22 (all previously vaccinated subjects) or Day 29 and Day 50 (all not previously vaccinated subjects) ]
  9. Safety: The percentage of subjects with solicited local adverse events (AE) [ Time Frame: Day 1 to Day 7 ]
  10. Safety: The percentage of subjects with solicited systemic AEs [ Time Frame: Day 1 to Day 7 ]
  11. Safety: The percentage of subjects with all unsolicited AEs [ Time Frame: Day 1 to Day 22 (for previously vaccinated subjects) or Day 1 to Day 50 (for not previously vaccinated subjects) ]
  12. Safety: Percentage of subjects with SAEs, AEs leading to withdrawal from the study and New Onset of Chronic Diseases (NOCD) [ Time Frame: Day 1 to Day 181 (for previously vaccinated subjects) or to Day 209 (for not previously vaccinated subjects) ]
  13. Safety: Percentage of subjects with medically-attended AEs [ Time Frame: Within 30 days of first occurrence of RT-PCR confirmed influenza-like-illness (ILI) ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy males or females ≥2 years to <18 years of age
  • Individual who or whose parent(s) or legal guardian have given informed consent /assent after the nature of the study has been explained according to local regulatory requirements, prior to study entry
  • Ability to comply with study procedures and are available for follow-up

Exclusion Criteria:

  • Hypersensitivity, including allergy to any component of vaccines foreseen in this study
  • Abnormal function of the immune system
  • Receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study.
  • Pregnant or breastfeeding individual
  • Female subject of childbearing potential, sexually active, and not used an acceptable method of birth control for at least 2 months prior to study entry and intend to use until the end of subject participation

Additional eligibility criteria may be discussed by contacting the site.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03165617


Locations
Australia, Queensland
AusTrials Pty Ltd
Sherwood, Queensland, Australia, 4075
Australia, Victoria
Murdoch Childrens Research Institute
Carlton, Victoria, Australia, 3010
Estonia
Merekivi Family Doctors Ltd
Tallinn, Harjumaa, Estonia, 10617
Merelahe Family Doctors Centre
Tallinn, Harjumaa, Estonia, 10617
Medicum AS
Tallinn, Harjumaa, Estonia, 13619
Vee Family Doctors Centre
Paide, Järvamaa, Estonia, 72713
Finland
Kokkola Vaccine Research Clinic
Kokkola, Finland, 67100
Philippines
De La Salle Health Sciences Institute
Dasmarinas, Cavite, Philippines, 4114
Philippine General Hospital
Manila, National Capital Region, Philippines, 1000
Research Institute For Tropical Medicine
Muntinlupa, National Capital Region, Philippines, 1781
Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, Muang, Thailand, 40002
ChiangMai University
Chiang Mai, Thailand, 50200
Sponsors and Collaborators
Seqirus
Investigators
Study Director: Clinical Physician Seqirus
More Information

Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT03165617     History of Changes
Other Study ID Numbers: V130_12
2016-002883-15 ( EudraCT Number )
First Posted: May 24, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Seqirus:
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs