Clinical trial NCT01007201: 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
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
H1N1
vaccine
Immunogenicity
Lead sponsor: Adimmune Corporation
Sponsor class: INDUSTRY
First posted: 2009-11-03
Enrollment: 183
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
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.
measure: 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 outcomes:
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.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan Hsien
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Li-Ming Huang
role: PRINCIPAL_INVESTIGATOR
affiliation: Chang Gung Memorial Hospital
name: Tzou-Yien Lin
role: PRINCIPAL_INVESTIGATOR
References: