Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old

Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old

The purpose of this study is to evaluate the antibody response to each of the three influenza vaccine strains included in the seasonal flu vaccine(AdimFlu-S), as measured by hemagglutination inhibition (HAI) at 4 weeks after two doses of study vaccine, 4 weeks apart, in infants between 6 and 12 months of age.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Phase 4

Contacts and Locations

Study Locations

• Taiwan
  • Taichung, Taiwan, 404
    • China Medicine University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Boys or girls and aged >= 6 months old to <= 12 months old on the day of first vaccination;
• Subject's parent(s) or 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's parent(s) or legal guardian(s) must read and signed the study-specific informed consent prior to initiation of any study procedure.

Exclusion Criteria:

• Subjects had received influenza vaccine;
• History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
• Personal or family history of Guillain- Barre' 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 >= 38'C) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, immunosuppressive or significant chronic illness not suitable for inactivated influenza vaccination;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
HA antibody titers will be determined using the WHO HAI reference technique.	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.	Safety data will consist of reactogenicity, serious and non-serious adverse events. Reactogenicity events are pre-specified adverse events systematically recorded for 7 days after each vaccination. The events included fever (≥38.0°C), runny nose or nasal congestion, cough, sore throat, muscle aches, headache, vomiting, nausea and malaise. Furthermore, the local (injection site) reactions were also evaluated, including soreness/pain, swelling, redness, ecchymosis and limitation of arm motion.	(4 weeks after two doses of study vaccine, 4 weeks apart), Physical examination will be performed at each visit. Reactogenicity will be recorded for 7 days after each vaccination.

Collaborators and Investigators

• Sponsor: Adimmune Corporation

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: May 15, 2011
• First Submitted That Met QC Criteria: May 17, 2011
• First Posted (Estimate): May 18, 2011

Study Record Updates

• Last Update Posted (Estimate): July 16, 2012
• Last Update Submitted That Met QC Criteria: July 12, 2012
• Last Verified: July 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: FLU10T11C