Immunogenicity and Safety Evaluation of QIS in Healthy Subjects

NCT04101435 | Completed Phase 3

• 1 other identifier: ADIMQIS20160328
• Study Type: interventional
• Target: 174
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Influenza

Keywords

Influenza Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (2)

• Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate

  The primary endpoint of immunogenicity evaluation was the seroconversion rate

  Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization

• Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by geometric mean folds increase

  The primary endpoint of immunogenicity evaluation was the geometric mean folds increase

  Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization

Secondary Outcomes (2)

• Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate

  Change from baseline for anti-hemaglutinin antibodies at 28 days post immunization

• 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)

  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

Study Arms (3)

Group A

EXPERIMENTAL

Aged 3 to 8 years old vaccine naïve subject (without prior seasonal influenza vaccine exposure)

Biological: AdimFlu-S (QIS)

Group B

ACTIVE COMPARATOR

Aged 3 to 8 years old vaccine non-naïve subject (with prior seasonal influenza vaccine exposure)

Biological: AdimFlu-S (QIS)

Group C

EXPERIMENTAL

Aged 9 to 17 years old subject

Biological: AdimFlu-S (QIS)

Interventions

AdimFlu-S (QIS) BIOLOGICAL

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.

Group A; Group B; Group C

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Subjects received influenza vaccine (Trivalent and/or Quadrivalent) within 6 months prior first vaccination.
• History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
• Personal or family history of Guillain-Barré Syndrome;
• An acute febrile illness within 1 week prior to vaccination;
• Current upper respiratory illness (URI), including the common cold or nasal congestion within 72 hours prior to vaccination;
• 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;
• 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;
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, or under immunosuppressive therapies;
• 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;
• 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;
• Receipt of any blood products, including immunoglobulin from 3 months before first vaccination to the last blood sampling for immunogenicity evaluation;
• Underlying condition in the investigators' opinion might interfere with evaluation of the vaccine.
• \. Treatment discontinuation
• 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.

Sponsors & Collaborators

• Adimmune Corporation: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2019
• First Posted: September 24, 2019
• Study Start: December 28, 2016
• Primary Completion: July 12, 2017
• Study Completion: December 27, 2017
• Last Updated: September 24, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share