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

This study has been completed.
Sponsor:
Information provided by:
Adimmune Corporation
ClinicalTrials.gov Identifier:
NCT01007201
First received: November 1, 2009
Last updated: January 19, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Influenza
Biological: Influenza A (H1N1) 2009 monovalent vaccine, inactivated

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

Resource links provided by NLM:


Further study details as provided by Adimmune Corporation:

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. [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: Yes ]

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. [ Designated as safety issue: No ]

Enrollment: 183
Study Start Date: October 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: AdimFlu-S (A/H1N1)

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007201

Locations
Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan Hsien, Taiwan
Sponsors and Collaborators
Adimmune Corporation
Investigators
Principal Investigator: Li-Ming Huang National Taiwan University Hospital
Principal Investigator: Tzou-Yien Lin Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Jeffrey Chen / Vice President, Adimmune Corporation
ClinicalTrials.gov Identifier: NCT01007201     History of Changes
Other Study ID Numbers: FLU09002
Study First Received: November 1, 2009
Last Updated: January 19, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by Adimmune Corporation:
Influenza
H1N1
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 April 22, 2014