Clinical trial NCT00778895: Clinical Study in Children, 6 Months to 3 Years of Age, to Assess Two Dose Levels of an Experimental Flu Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Official title: Clinical Study in Children, 6 Months to 3 Years of Age, to Assess the Immunogenicity and Safety of Two Dose Levels of Thimerosal-free Fluviral® Vaccine, Using a Licensed Influenza Virus Vaccine, Vaxigrip® as the Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Keywords: Flu
Safety
Immunogenicity
Flu vaccine
Influenza
Virus
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 390
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Children younger than 5 years of age are at high risk for severe influenza disease (flu) and hospitalization due to flu. Scientists are in the process of re-evaluating the dosing initially based on whole virus vaccines to improve their efficacy in infants. In this study, we will compare two different dose levels of GSK1557482A flu vaccine. Another already approved flu vaccine made by a different company will be used as a control.

Detailed description: This is a study of two different dose levels of a new formulation of flu vaccine for the 2008/2009 flu season using the World Health Organization recommended virus strains. Subjects will be randomly put into one of three different groups to receive either one or two doses of:

0.25 mL dose of the new flu vaccine, or 0.5 mL dose of the new flu vaccine or the licensed Vaxigrip flu vaccine (control) The parents of the subjects and the study doctor and nurses will not know the group of their child until the study is completed.

The children will be vaccinated with either one dose or two doses depending on whether or not they have received a flu vaccine before. The doctor will decide on the schedule for each child based on the information provided by the parents. The active phase of the study will last approximately two months for children receiving two doses and one month for those receiving a single dose. An extended safety follow-up will continue until Study Month 6.

Two blood samples will be taken from each subject. These will be used to evaluate how well the vaccine works in the children and which dose level works best compared to the control.

The parents will fill in a diary card for four days to record any reactions or symptoms which may occur after vaccination. Parents will also keep a record of other symptoms that may occur between vaccinations and up to six months after the first vaccination and will keep a record of any medication their child takes in this time period.

Eligibility criteria: Inclusion Criteria:

* A male or female child 6 months to \< 3 years of age at the time of the vaccination, regardless of previous administration of influenza vaccine in a previous season;
* Subjects must be in good health established by medical history and physical examination before entering into the study;
* Subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study;
* Written informed consent obtained from the subject's parent/guardian.
* Parents/guardian access to a consistent means of telephone contact, land line or mobile

Exclusion Criteria:

* Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine or planned use during the study period. Routine, registered childhood vaccinations are not an exclusion criterion;
* History of hypersensitivity to any vaccine;
* History of allergy to or reactions likely to be exacerbated by, any component of the vaccine including egg, chicken protein, formaldehyde, or sodium deoxycholate;
* History of any congenital, acquired, or iatrogenic immunodeficiency state (current or potential) including HIV infection, disorders of the lymphoid system or bone marrow, or chronic administration (defined as more than 14 consecutive days) of immunosuppressant or other immune-modifying drugs within 3 months prior to the administration of the study vaccine.
* Acute disease at the time of enrolment.
* History of Guillain Barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine;
* Any significant disorder of blood coagulation or treatment with vitamin K antagonists; or any known disorder of hemostasis;
* Receipt of any immunoglobulins and/or any blood products within three months of study enrollment or planned administration of any of these products during the study period.
* Receipt of a non-study related influenza vaccine outside of this study and during the current (2008-09) influenza immunization campaign.
* Any use of analgesics/antipyretics 12 hours before receipt of vaccine.

Primary outcomes:
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
timeFrame: During the 4-day follow-up period (Days 0-3) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
timeFrame: During the 4-day follow-up period (Days 0-3) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
timeFrame: During the 28-day follow-up period (Days 0-27) after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
timeFrame: During the 28-day post-vaccination period
measure: Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
timeFrame: During the 6-month safety follow up after vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
timeFrame: During the 28-day post-vaccination period
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
timeFrame: During the 6-month safety follow up after vaccination
Secondary outcomes:
measure: Titers for Serum Hemagglutination Inhibition (HI) Antibodies
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
measure: Number of Subjects Seroconverted to HI Antibodies
timeFrame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
measure: Number of Subjects Seroprotected Against HI Antibodies
timeFrame: At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
measure: Seroconversion Factor for HI Antibodies
timeFrame: At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
measure: Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
timeFrame: During the 4-day follow-up period (Days 0-3) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
timeFrame: During the 4-day follow-up period (Days 0-3) after any vaccination
measure: Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
timeFrame: During the 28-day follow-up period (Days 0-27) after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
timeFrame: During the 28-day post-vaccination period after vaccination
measure: Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
timeFrame: During the 6-month safety follow up after vaccination
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
timeFrame: During the 28-day post-vaccination period
measure: Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
timeFrame: During the 6-month safety follow up after vaccination
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: GSK Investigational Site
state: Alberta
city: Langley
country: Canada
facility: GSK Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: GSK Investigational Site
state: Manitoba
city: Mount Pearl
country: Canada
facility: GSK Investigational Site
state: Newfoundland and Labrador
city: Halifax
country: Canada
facility: GSK Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: London
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Mississauga
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Newmarket
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sarnia
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Sudbury
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
city: Charlottetown
country: Canada
facility: GSK Investigational Site
state: Prince Edward Island
city: Montreal
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Quebec City
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Ste-Foy
country: Canada
facility: GSK Investigational Site
state: Quebec
city: Trois Rivières
country: Canada
facility: GSK Investigational Site
state: Quebec
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Langley JM, Vanderkooi OG, Garfield HA, Hebert J, Chandrasekaran V, Jain VK, Fries L. Immunogenicity and Safety of 2 Dose Levels of a Thimerosal-Free Trivalent Seasonal Influenza Vaccine in Children Aged 6-35 Months: A Randomized, Controlled Trial. J Pediatric Infect Dis Soc. 2012 Mar;1(1):55-63. doi: 10.1093/jpids/pis012. Epub 2012 Mar 1.