Immunogenicity and Safety Evaluation of QIS in Healthy Subjects

Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) in Healthy Subjects Aged 3 Years Old to 17 Years Old

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.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: AdimFlu-S (QIS)

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 months to 13 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A; Aged 3 to 8 years old vaccine naïve subject (without prior seasonal influenza vaccine exposure)	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.
Active Comparator: Group B; Aged 3 to 8 years old vaccine non-naïve subject (with prior seasonal influenza vaccine exposure)	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.
Experimental: Group C; Aged 9 to 17 years old subject	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroprotection rate	The secondary endpoint of immunogenicity evaluation was the 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)	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	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

Collaborators and Investigators

• Sponsor: Adimmune Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2016
• Primary Completion (Actual): July 12, 2017
• Study Completion (Actual): December 27, 2017

Study Registration Dates

• First Submitted: September 17, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 24, 2019

Study Record Updates

• Last Update Posted (Actual): September 24, 2019
• Last Update Submitted That Met QC Criteria: September 22, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Immunogenicity; Influenza Vaccine
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: ADIMQIS20160328

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No