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

Adimmune

Status and phase

Completed

Phase 4

Conditions

Influenza

Treatments

Biological: AdimFlu-S

Study type

Interventional

Funder types

Industry

Identifiers

NCT01355172

FLU10T11C

Details and patient eligibility

About

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.

Enrollment

59 patients

Sex

All

Ages

6 months to 1 year old

Volunteers

Accepts Healthy Volunteers

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.