Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population

January 19, 2012 updated by: Adimmune Corporation

A Clinical Study to Assess the Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Healthy Subjects Aged Over 1 Year Old to 18 Years Old

This is a laboratory-blinded study in healthy toddlers, children, and teenagers designed to investigate the safety, reactogenicity, and immunogenicity of an inactivated influenza H1N1 vaccine (AdimFlu-S). There are 3 age strata, and each contains at least 50 subjects: greater than or equal to 1 year to less than 3 years, greater than or equal to 3 years to less than 6 years, and greater than or equal to 6 years to less than 18 years. In each age strata, all eligible subjects received 2 injections of AdimFlu-S (A/H1N1) at a designated dosage level (7.5 μg, 15 μg and 15 μg for 1~<3, 3~<6 and 6~<18 years, respectively) at 3 weeks apart.

Following immunization, safety is measured by assessment of adverse events for 6 weeks following the first vaccination, serious adverse events and new-onset chronic medical conditions through 7 months post first vaccination, and reactogenicity to the vaccines for 7 days following each vaccination. Immunogenicity testing includes hemagglutination inhibition (HAI) testing on serum obtained before first vaccination, and three and six weeks after first vaccination.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

183

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taoyuan Hsien, Taiwan
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Boys or girls aged ≧ 1 year old to 18 years old on the day of first vaccination;
  • Subject and/or parents(s)/legal guardian(s) was willing to comply with planned study procedures and be available for all study visits;
  • Subject was 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:

  • Subject ever received influenza vaccine within the previous 6 months;
  • History of hypersensitivity to eggs or egg protein or similar pharmacological effects to study medication (AdimFlu-S (A/H1N1));
  • Personal or family history of Guillain-Barré Syndrome;
  • An acute febrile illness within the last 72 hours prior to vaccination;
  • Subject with bleeding disorder or has any coagulation disorder that needs receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating intramuscular injection;
  • Subjects with influenza-like illness as defined by the presence of fever (temperature ≧38.5℃ ) 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 vaccination or expected receipt within 2 months after first study vaccination;
  • Receipt of any inactivated vaccine within 2 weeks prior to study vaccination or expected receipt vaccination within 3 weeks after the immunogenicity evaluation period;
  • Receipt of any blood products, including immunoglobulin in the prior 3 months;
  • Underlying condition in the investigator's opinion may be inappropriate for vaccination;
  • Significant chronic illness for which inactivated influenza vaccine is recommended or commonly used.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: H1N1 vaccine of 15 μg HA on Day 0 and 21
15 μg HA (0.5 mL) per injection, 2 injections 50 children (aged over 3 years old to 6 years old) and 50 children/teenagers (aged over 6 years old to 18 years old) were assigned to receive two injections of H1N1 vaccine 3 weeks apart
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Names:
  • AdimFlu-S (A/H1N1)
Experimental: H1N1 vaccine of 7.5 μg HA on Day 0 and 21
7.5 μg HA (0.25 mL) per injection, 2 injections 50 toddlers (aged over 1 year old to 3 years old) were assigned to receive two injections of H1N1 vaccine 3 weeks apart
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Names:
  • AdimFlu-S (A/H1N1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary immunogenicity objective is to assess the antibody response following a single dose of study vaccine, grouped by age of recipient, when administered at the 7.5 or 15 μg HA doses.
The primary safety objective of this study is to assess the safety of the study vaccine when administered at the 7.5 or 15 μg HA doses.

Secondary Outcome Measures

Outcome Measure
The secondary immunogenicity objective is to assess the antibody response following 2 doses of study vaccine, grouped by age of recipient, when administered at the 7.5 or 15 μg HA doses.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adimmune Corporation

Investigators

  • Principal Investigator: Li-Ming Huang, National Taiwan University Hospital
  • Principal Investigator: Tzou-Yien Lin, Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 1, 2009

First Submitted That Met QC Criteria

November 1, 2009

First Posted (Estimate)

November 3, 2009

Study Record Updates

Last Update Posted (Estimate)

January 20, 2012

Last Update Submitted That Met QC Criteria

January 19, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLU09002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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