GSK: Protocol Summary for 111635

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Protocol Summary for 111635

Protocol Summary
Protocol Id:	111635
Secondary Ids:	N/A
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
Phase:	phase 2
Acronym:
FDA Regulated Intervention?:	Yes
Section 801 Clinical Trial?:	Yes
Delayed Posting:	No
IND/IDE Protocol?:	no
Study Type:	Interventional
Oversight Authority:	Canada: Health Canada
Collaborators:	N/A
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.
Record Verification Date:	March 2011
Status:	Completed
Why Study Stopped:
Study Start Date:	November 2008
Study Completion Date:	August 2009
Study Completion Date Type:	Actual
Primary Completion Date:	August 2009
Primary Completion Date Type:	Actual
Primary Purpose:	prevention
Allocation:	Randomized
Masking:	Double Blind
Masked Subject:	yes
Masked Caregiver:	yes
Masked Investigator:	yes
Masked Assessor:	yes
Study Design (Assignment):	Parallel Assignment
Study Classification (Endpoint):	Safety/Efficacy Study
Primary Outcomes:	Evaluation of the humoral immune response for HI antibodies by calculating the post vaccination geometric mean titer (GMT) with 95% Confidence Intervals (CIs) after completion of the vaccine regimen for Groups A and B no approximately 28 days after the last dose of either vaccine Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general symptoms for Groups A and B. no day of vaccination and 3 subsequent days Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general symptoms for Groups A and B. no day of vaccination and 27 subsequent days Occurrence, intensity and investigator's assessment of relationship to vaccine of medically-attended AEs and SAEs reported for Groups A and B. no during the entire study period and through the six month safety follow-up period
Secondary Outcomes:	GMTs calculated at pre-vaccination and after completion of the vaccine regimen with 95% Confidence Intervals (CIs) for all groups no approximately 28 days following the last dose of the vaccine Seroconversion Rates (SCR) calculated with 95% Confidence Intervals (CIs) for all groups no at approximately 28 days following the last dose of the vaccine Seroprotection Rates (SPR) calculated with 95% Confidence Intervals (CIs) for all groups no at pre-vaccination and at approximately 28 days following the last dose of the vaccine Seroconversion Factors (SCF) calculated with 95% Confidence Intervals (CIs) for all groups no at approximately 28 days following the last dose of the vaccine compared to pre-vaccination (Day 0) Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general symptoms for Group C no day of vaccination and 3 subsequent days after vaccination Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general symptoms for Group C no day of vaccination and 27 subsequent days Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically-attended visits for Group C. no during the entire study period and through the six month safety follow-up period
Conditions:	Influenza virus
Keywords:	Influenza Virus Flu Flu vaccine Safety Immunogenicity
Eligibility Criteria:	Click to view inclusion/exclusion 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.
Gender:	Both
Minimum Age:	6 Months
Maximum Age:	36 Months
Enrollment:	403
Enrollment Type:	Actual
Healthy Volunteers?:	yes
Central Contact:	US GSK Clinical Trials Call Center
Central Contact Phone:	877-379-3718
Central Contact Email:	GSKClinicalSupportHD@gsk.com
Backup Central Contact:	EU GSK Clinical Trials Call Center
Backup Central Contact Phone:	+44 (0) 20 8990 4466
Backup Central Contact Email:	GSKClinicalSupportHD@gsk.com
Overall Study Official:	GSK Clinical Trials
Overall Study Official Affiliation:	GlaxoSmithKline
Overall Study Official Role:	Study Director
Responsible Party Name/Official Title:	Cheri Hudson; Clinical Disclosure Advisor
Responsible Party Organization:	GSK Clinical Disclosure
Location and Contact Information:	Click to view location information Canada (click to view all sites in Canada) GSK Investigational Site Calgary, Alberta, T3B 6A8; Completed; GSK Investigational Site Langley, British Columbia, V3A 4H9; Completed; GSK Investigational Site Winnipeg, Manitoba, R3E 3P4; Completed; GSK Investigational Site Mount Pearl, Newfoundland and Labrador, A1N 5B6; Completed; GSK Investigational Site Halifax, Nova Scotia, B3K 6R8; Completed; GSK Investigational Site Sudbury, Ontario, P3E 1H5; Completed; GSK Investigational Site Toronto, Ontario, M5G 1N8; Completed; GSK Investigational Site Hamilton, Ontario, L8L 5G8; Completed; GSK Investigational Site Mississauga, Ontario, L5A 3V4; Completed; GSK Investigational Site London, Ontario, N6H 4P2; Completed; GSK Investigational Site Newmarket, Ontario, L3Y 5G8; Completed; GSK Investigational Site Sarnia, Ontario, N7T 4X3; Completed; GSK Investigational Site Charlottetown, Prince Edward Island, C1A 5N4; Completed; GSK Investigational Site Ste-Foy, Québec, G1X 3V7; Completed; GSK Investigational Site Montreal, Québec, H3T 1C5; Completed; GSK Investigational Site Quebec City, Québec, G1V 4M6; Completed; GSK Investigational Site Trois Rivières, Québec, G8T 7A1; Completed;

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Protocol Summary for 111635