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Immunogenicity and Safety Evaluation of QIS in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04101435
Recruitment Status : Completed
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Adimmune Corporation

Tracking Information
First Submitted Date  ICMJE September 17, 2019
First Posted Date  ICMJE September 24, 2019
Last Update Posted Date September 24, 2019
Actual Study Start Date  ICMJE December 28, 2016
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 22, 2019)
  • Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate [ Time Frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization ]
    The primary endpoint of immunogenicity evaluation was the seroconversion rate
  • Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by geometric mean folds increase [ Time Frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization ]
    The primary endpoint of immunogenicity evaluation was the geometric mean folds increase
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2019)
  • Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate [ Time Frame: Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization ]
    The secondary endpoint of immunogenicity evaluation was the seroprotection rate
  • Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of the AdimFlu-S (QIS) [ Time Frame: In regard to the long term safety of the study vaccine, the significant and/or serious adverse event(s) will be recorded during the 6 months follow up after the scheduled last vaccination ]
    Evaluate the safety and tolerability profiles including the presence or absence of the pre-specified reactogenicity events and other serious/non-serious adverse events of QIS. Reactogenicity events were pre-specified adverse events systematically recorded on diary cards during post-vaccination period by all participants for 7 days after each vaccination. Unsolicited adverse events were recorded on the diary card till 28 days post vaccination, while serious adverse events should be recorded throughout the study period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety Evaluation of QIS in Healthy Subjects
Official Title  ICMJE Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) in Healthy Subjects Aged 3 Years Old to 17 Years Old
Brief Summary The purpose of this study was to evaluate the antibody response to each of the four influenza vaccine strains included in the study vaccine, as measured by hemagglutination inhibition (HAI) at 4 weeks after the last dose of the study vaccine in young subjects aged between 3 years old and 17 years old.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Influenza
Intervention  ICMJE Biological: AdimFlu-S (QIS)
This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine.
Study Arms  ICMJE
  • Experimental: Group A
    Aged 3 to 8 years old vaccine naïve subject (without prior seasonal influenza vaccine exposure)
    Intervention: Biological: AdimFlu-S (QIS)
  • Active Comparator: Group B
    Aged 3 to 8 years old vaccine non-naïve subject (with prior seasonal influenza vaccine exposure)
    Intervention: Biological: AdimFlu-S (QIS)
  • Experimental: Group C
    Aged 9 to 17 years old subject
    Intervention: Biological: AdimFlu-S (QIS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 22, 2019)
174
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 27, 2017
Actual Primary Completion Date July 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Boys or girls aged 3 years old to 17 years old on the day of first vaccination;
  2. Subject and/or parents(s)/legal guardian(s) must be willing to comply with planned study procedures and be available for all study visits;
  3. Subject must be in good physical health on the basis of medical history, physical examination;
  4. Subject and/or parents(s)/legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.

Exclusion Criteria:

Main exclusion criteria:

  1. Subjects received influenza vaccine (Trivalent and/or Quadrivalent) within 6 months prior first vaccination.
  2. History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
  3. Personal or family history of Guillain-Barré Syndrome;
  4. An acute febrile illness within 1 week prior to vaccination;
  5. Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours prior to vaccination;
  6. Subjects with influenza-like illness as defined by the presence of fever (temperature >38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
  7. Female subjects who were pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagreed to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
  8. Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
  9. Immunodeficiency, or under immunosuppressive therapies;
  10. Receipt of live virus vaccine within 1 month prior to study vaccination or expected to receive vaccination before the last blood sampling for immunogenicity evaluation;
  11. Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected to receive vaccination before the last blood sampling for immunogenicity evaluation;
  12. Receipt of any blood products, including immunoglobulin from 3 months before first vaccination to the last blood sampling for immunogenicity evaluation;
  13. Underlying condition in the investigators' opinion might interfere with evaluation of the vaccine.

3. Treatment discontinuation

  1. Withdrawal criteria i. Subject/Subject's guardians decided to withdraw consent. ii. Lost to follow-up. iii. Administration of prohibited medication/treatment/vaccine. iv. Any pathological event, clinical adverse event, or any change in the subject's status giving indication to the pediatrician that further participation in the study might not be the best interests of the subject, according to investigator's discretion.
  2. Contraindications to second vaccination

Subject with any of the following criteria might be contraindicated to take the second vaccination:

i. Had any Grade 3 or Grade 4 adverse reaction within 7 days after first dose. ii. Had any SAE related to first dose during the follow-up of first dose. iii. Any situations met the exclusion criteria, except the exclusion criterion (1) and (8).

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04101435
Other Study ID Numbers  ICMJE ADIMQIS20160328
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adimmune Corporation
Study Sponsor  ICMJE Adimmune Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Adimmune Corporation
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP