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

NCT01355172 | Completed Phase 4 DMC

• 1 other identifier: FLU10T11C
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Interventions

AdimFlu-S BIOLOGICAL

0.25mL per injection 2 injections at 4 weeks apart

Eligibility Criteria

• Age: 6 Months - 1 Year
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adimmune Corporation: lead

Study Sites (1)

China Medicine University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2011
• First Posted: May 18, 2011
• Study Start: November 1, 2010
• Primary Completion: September 1, 2011
• Last Updated: July 16, 2012

Record last verified: 2012-07

Locations

TW (1)