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

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:

MedlinePlus related topics: Flu

U.S. FDA Resources

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 May 23, 2013