Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old

This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.

Study Overview

• Status: Completed
• Conditions: Influenza
• Intervention / Treatment: Biological: AdimFlu-S 2010-2011, inactivated

• Study Type: Interventional
• Enrollment (Actual): 181
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Boys or girls and aged 6 months old to 18 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:

• Subjects received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months;
• 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;
• Subjects with influenza-like illness as defined by the presence of fever (temperature ³38ºC) 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 are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree 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, immunosuppressive or household contact with immunosuppression;
• History of wheezing or bronchodilator use within 3 months prior to study vaccine;
• Receipt of live virus vaccine within 1 month prior to study vaccine or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
• Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination before the last blood sampling for immunogenicity evaluation;
• Receipt of any blood products, including immunoglobulin in the prior 3 months;
• Underlying condition in the investigators' opinion may interfere with evaluation of the vaccine;
• Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AdimFlu-S 2010-2011, 6 months~<3 years	Biological: AdimFlu-S 2010-2011, inactivated; The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart 3~<9 years;0.5 mL per injection2 injections at 4 weeks apart 9~<18 years;0.5 mL per injection1 injections
Experimental: AdimFlu-S 2010-2011,3~<9 years	Biological: AdimFlu-S 2010-2011, inactivated; The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart 3~<9 years;0.5 mL per injection2 injections at 4 weeks apart 9~<18 years;0.5 mL per injection1 injections
Experimental: AdimFlu-S 2010-2011,9~<18 years	Biological: AdimFlu-S 2010-2011, inactivated; The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart 3~<9 years;0.5 mL per injection2 injections at 4 weeks apart 9~<18 years;0.5 mL per injection1 injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.	Serum samples will be obtained prior to vaccination, and 4 weeks after each vaccination. Serum samples will be tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.	Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The secondary objective is to 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 manufactured by Adimmune Corporation.	Reactogenicity events are pre-specified adverse events systematically recorded on diary cards (a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after each vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection.	Safety data will consist of reactogenicity, serious and non-serious adverse events throughout the study, including 7 days after each dose of study vaccine. Vital signs and physical examination will be performed at each clinic visit.

Collaborators and Investigators

• Sponsor: Adimmune Corporation

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: May 16, 2011
• First Submitted That Met QC Criteria: May 18, 2011
• First Posted (Estimate): May 19, 2011

Study Record Updates

• Last Update Posted (Estimate): December 28, 2012
• Last Update Submitted That Met QC Criteria: December 27, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Influenza; Vaccine; Immunogenicity
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: FLU10T11B