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

Adimmune Corporation0 sites174 target enrollmentDecember 28, 2016

ConditionsInfluenza

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Influenza
Sponsor: Adimmune Corporation
Enrollment: 174
Primary Endpoint: Evaluate the immunogenicity profiles for influenza virus vaccine strains of the AdimFlu-S (QIS) by seroconversion rate
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 28, 2016

End Date

December 27, 2017

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Adimmune Corporation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•Main exclusion criteria:
•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;

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)