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 - Full Text View

Sponsored by:	GlaxoSmithKline
Information provided by:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00778895

Purpose

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.

Condition	Intervention	Phase
Influenza Virus	Biological: GSK Biologicals' influenza vaccine GSK1557482A Biological: Vaxigrip	Phase II

MedlinePlus related topics: Flu

Drug Information available for: Fluvirin Influenza Vaccines

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

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 [ Time Frame: approximately 28 days after the last dose of either vaccine ] [ Designated as safety issue: No ]
Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general symptoms for Groups A and B. [ Time Frame: day of vaccination and 3 subsequent days ] [ Designated as safety issue: No ]
Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general symptoms for Groups A and B. [ Time Frame: day of vaccination and 27 subsequent days ] [ Designated as safety issue: No ]
Occurrence, intensity and investigator's assessment of relationship to vaccine of medically-attended AEs and SAEs reported for Groups A and B. [ Time Frame: during the entire study period and through the six month safety follow-up period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

GMTs calculated at pre-vaccination and after completion of the vaccine regimen with 95% Confidence Intervals (CIs) for all groups [ Time Frame: approximately 28 days following the last dose of the vaccine ] [ Designated as safety issue: No ]
Seroconversion Rates (SCR) calculated with 95% Confidence Intervals (CIs) for all groups [ Time Frame: at approximately 28 days following the last dose of the vaccine ] [ Designated as safety issue: No ]
Seroprotection Rates (SPR) calculated with 95% Confidence Intervals (CIs) for all groups [ Time Frame: at pre-vaccination and at approximately 28 days following the last dose of the vaccine ] [ Designated as safety issue: No ]
Seroconversion Factors (SCF) calculated with 95% Confidence Intervals (CIs) for all groups [ Time Frame: at approximately 28 days following the last dose of the vaccine compared to pre-vaccination (Day 0) ] [ Designated as safety issue: No ]
Occurrence, intensity and investigator's assessment of relationship to vaccine of solicited local and general symptoms for Group C [ Time Frame: day of vaccination and 3 subsequent days after vaccination ] [ Designated as safety issue: No ]
Occurrence, intensity, and investigator's assessment of relationship to vaccine of unsolicited local and general symptoms for Group C [ Time Frame: day of vaccination and 27 subsequent days ] [ Designated as safety issue: No ]
Occurrence, intensity and investigator's assessment of relationship to vaccine of SAEs and medically-attended visits for Group C. [ Time Frame: during the entire study period and through the six month safety follow-up period ] [ Designated as safety issue: No ]

Estimated Enrollment:	450
Study Start Date:	November 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group B: Experimental 0.50 mL dose level of GSK1557482A	Biological: GSK Biologicals' influenza vaccine GSK1557482A one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Group A: Experimental 0.25 mL dose level of GSK1557482A	Biological: GSK Biologicals' influenza vaccine GSK1557482A one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).
Group C: Active Comparator 0.50 mL dose level of Vaxigrip	Biological: Vaxigrip one IM injection at Day 0 for primed subjects (defined as subjects who had a prior 2-dose priming influenza immunization) or two IM injections at Day 0 and approximately Day 28 for un-primed subjects (defined as subjects who have not previously received a complete 2-dose priming influenza immunization).

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

Ages Eligible for Study:	6 Months to 36 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778895

Locations

Canada, Alberta
GSK Investigational Site
Calgary, Alberta, Canada, T3B 6A8
Canada, British Columbia
GSK Investigational Site
Langley, British Columbia, Canada, V3A 4H9
Canada, Manitoba
GSK Investigational Site
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
GSK Investigational Site
Mount Pearl, Newfoundland and Labrador, Canada, A1N 5B6
Canada, Nova Scotia
GSK Investigational Site
Halifax, Nova Scotia, Canada, B3K 6R8
Canada, Ontario
GSK Investigational Site
Sudbury, Ontario, Canada, P3E 1H5
GSK Investigational Site
Sarnia, Ontario, Canada, N7T 4X3
GSK Investigational Site
Mississauga, Ontario, Canada, L5A 3V4
GSK Investigational Site
Hamilton, Ontario, Canada, L8L 5G8
GSK Investigational Site
Toronto, Ontario, Canada, M5G 1N8
GSK Investigational Site
London, Ontario, Canada, N6H 4P2
GSK Investigational Site
Newmarket, Ontario, Canada, L3Y 5G8
Canada, Prince Edward Island
GSK Investigational Site
Charlottetown, Prince Edward Island, Canada, C1A 5N4
Canada, Quebec
GSK Investigational Site
Trois Rivières, Quebec, Canada, G8T 7A1
GSK Investigational Site
Montreal, Quebec, Canada, H3T 1C5
GSK Investigational Site
Ste-Foy, Quebec, Canada, G1X 3V7
GSK Investigational Site
Quebec City, Quebec, Canada, G1V 4M6

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	111635
Study First Received:	October 23, 2008
Last Updated:	April 30, 2009
ClinicalTrials.gov Identifier:	NCT00778895 History of Changes
Health Authority:	Canada: Health Canada

Keywords provided by GlaxoSmithKline:

Influenza
Virus
Flu

Flu vaccine
Safety
Immunogenicity

Study placed in the following topic categories:

Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

Additional relevant MeSH terms:

Virus Diseases
RNA Virus Infections
Respiratory Tract Diseases

Respiratory Tract Infections
Influenza, Human
Orthomyxoviridae Infections

ClinicalTrials.gov processed this record on May 07, 2009