Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old

NCT01356342 | Completed Phase 4

• 1 other identifier: FLU10T11B
• Study Type: interventional
• Target: 181
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects aged between 6 months old to 18 years old. All participants will be divided into three age cohorts. First, participants aged 6 through \< 36 months will receive 2 doses of 0.25 mL vaccine separated by 4 weeks. Second, participants aged 3 through \< 9 years will receive 2 doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through \< 18 years will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the time of vaccination, solicited local and systemic reactions within 7 days after each vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood samples will be collected from each subject immediately prior to, and 4 weeks after each vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO haemaglutination inhibition reference technique. The analysis will be observer-blinded. All participants will be followed, either by clinical visit or by telephone contact, for 6 months after the first vaccination for safety reasons.

Conditions

Influenza

Keywords

Influenza; Vaccine; Immunogenicity

Outcome Measures

Primary Outcomes (1)

• The primary objective is to evaluate the immunogenicity profiles for influenza virus vaccine strains (2010-2011 season) of the AdimFlu-S manufactured by Adimmune Corporation.

  Serum samples will be obtained prior to vaccination, and 4 weeks after each vaccination. Serum samples will be tested for anti-hemaglutinin (HA) antibodies by hemagglutinaton inhibition (HAI), and assays will be performed at Adimmune Corporation designated central laboratory. Subjects will be considered to be seronegative if serum HAI titer\<1:10. The seroconversion is defined as the post-vaccination serum at least 40 for whom had negative pre-vaccination or a fourfold or greater increase in HAI titers in subjects who had positive pre-vaccination serum.

  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.

  Safety data will consist of reactogenicity, serious and non-serious adverse events throughout the study, including 7 days after each dose of study vaccine. Vital signs and physical examination will be performed at each clinic visit.

Study Arms (3)

AdimFlu-S 2010-2011, 6 months~<3 years

EXPERIMENTAL

Biological: AdimFlu-S 2010-2011, inactivated

AdimFlu-S 2010-2011,3~<9 years

EXPERIMENTAL

Biological: AdimFlu-S 2010-2011, inactivated

AdimFlu-S 2010-2011,9~<18 years

EXPERIMENTAL

Biological: AdimFlu-S 2010-2011, inactivated

Interventions

AdimFlu-S 2010-2011, inactivated BIOLOGICAL

The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL 6 months\~\<3 years;0.25 mL per injection2 injections at 4 weeks apart 3\~\<9 years;0.5 mL per injection2 injections at 4 weeks apart 9\~\<18 years;0.5 mL per injection1 injections

AdimFlu-S 2010-2011, 6 months~<3 years; AdimFlu-S 2010-2011,3~<9 years; AdimFlu-S 2010-2011,9~<18 years

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Boys or girls and aged 6 months old to 18 years old on the day of first vaccination;
• Subject and/or parents(s)/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 and/or parents(s)/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 received influenza vaccine (Trivalent and/or A(H1N1)) within the previous 6 months;
• History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication;
• Personal or family history of Guillain-Barré 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 ³38ºC) and at least two of the following four symptoms: headache, muscle/joint aches and pains (e.g. myalgia/arthralgia), sore throat and cough;
• Female subjects who are pregnant, lactating or likely to become pregnant during the study; Women of childbearing potential disagree to use an acceptable method of contraception (e.g., hormonal contraceptives, IUD, barrier device or abstinence) throughout the study;
• Treatment with an investigational drug or device, or participation in a clinical study, within 3 months before consent;
• Immunodeficiency, immunosuppressive or household contact with immunosuppression;
• 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;
• Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Sponsors & Collaborators

• Adimmune Corporation: lead

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: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 19, 2011
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 28, 2012

Record last verified: 2012-12