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

Primary Purpose

Influenza

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Sponsored by
Adimmune Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, H1N1, vaccine, Immunogenicity

Eligibility Criteria

1 Year - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

H1N1 vaccine of 15 μg HA on Day 0 and 21

H1N1 vaccine of 7.5 μg HA on Day 0 and 21

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
November 1, 2009
Last Updated
January 19, 2012
Sponsor
Adimmune Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01007201
Brief Title
Immunogenicity and Safety of Influenza Virus Vaccine, AdimFlu-S (A/H1N1), in Pediatric Population
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Adimmune Corporation

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, H1N1, vaccine, Immunogenicity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
183 (Actual)

8. Arms, Groups, and Interventions

Arm Title
H1N1 vaccine of 15 μg HA on Day 0 and 21
Arm Type
Experimental
Arm Description
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
Arm Title
H1N1 vaccine of 7.5 μg HA on Day 0 and 21
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Influenza A (H1N1) 2009 monovalent vaccine, inactivated
Other Intervention Name(s)
AdimFlu-S (A/H1N1)
Primary Outcome Measure Information:
Title
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.
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li-Ming Huang
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tzou-Yien Lin
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan Hsien
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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