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

Adimmune Corporation1 site in 1 country59 target enrollmentNovember 2010

ConditionsInfluenza

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Influenza
Sponsor: Adimmune Corporation
Enrollment: 59
Locations: 1
Primary Endpoint: HA antibody titers will be determined using the WHO HAI reference technique.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2010

End Date

September 2011

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Adimmune Corporation

Responsible Party

Sponsor

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;

Outcomes

Primary Outcomes

HA antibody titers will be determined using the WHO HAI reference technique.

Time Frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination.

Secondary Outcomes

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.((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.)