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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01356342
First received: May 16, 2011
Last updated: December 27, 2012
Last verified: December 2012
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: AdimFlu-S 2010-2011, inactivated
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

Primary Outcome Measures:
  • 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. [ Time Frame: Serum samples will be obtained prior to vaccination (baseline), and 4 weeks after each vaccination. ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • 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. [ Time Frame: 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. ] [ Designated as safety issue: Yes ]
    Reactogenicity events are pre-specified adverse events systematically recorded on diary cards (a grid of check boxes for each event and each day) during the immediate post-vaccination period by all participants. In general, reactogenicity events will be recorded for 7 days after each vaccination. The selection of the events to be collected systematically is based on events expected to occur with wild-type influenza infection.


Enrollment: 181
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AdimFlu-S 2010-2011, 6 months~<3 years Biological: AdimFlu-S 2010-2011, inactivated

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

Experimental: AdimFlu-S 2010-2011,3~<9 years Biological: AdimFlu-S 2010-2011, inactivated

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

Experimental: AdimFlu-S 2010-2011,9~<18 years Biological: AdimFlu-S 2010-2011, inactivated

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


  Eligibility

Ages Eligible for Study:   6 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01356342     History of Changes
Other Study ID Numbers: FLU10T11B
Study First Received: May 16, 2011
Last Updated: December 27, 2012
Health Authority: Taiwan: Taiwan Food and Drug Administration

Keywords provided by Adimmune Corporation:
Influenza
Vaccine
Immunogenicity

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014