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
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.

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 October 01, 2014