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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01007201
• Other study ID #: FLU09002
• Status: Completed
• Phase: N/A
• First received: November 1, 2009
• Last updated: January 19, 2012
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: January 2012
• Source: Adimmune Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 17 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Chang Gung Memorial Hospital	Taoyuan Hsien

Sponsors (1)

Lead Sponsor	Collaborator
Adimmune Corporation

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.			No
Primary	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.			Yes
Secondary	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.			No