Clinical trial NCT01355172: Immunogenicity and Safety of AdimFlu-S, Formulation 2010-2011, in Infants Aged Between 6-12months Old
Official title: Clinical Study Protocol Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011， in Infants Aged Between 6-12months Old
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Influenza
Keywords: Influenza
Vaccine
Immunogenicity
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2011-05-18
Enrollment: 59
Sex: ALL
Minimum age (years): 6
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: HA antibody titers will be determined using the WHO HAI reference technique.
timeFrame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.
Secondary outcomes:
measure: 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.
timeFrame: (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.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medicine University Hospital
Study officials:
References: