Back to resultsClinical 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
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
GSK Biologicals' influenza vaccine GSK1557482A
Vaxigrip
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Flu, Safety, Immunogenicity, Flu vaccine, Influenza, Virus
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Fluviral F1 Group
Fluviral F2 Group
Vaxigrip Group
Arm Description
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Outcomes
Primary Outcome Measures
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Secondary Outcome Measures
Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
Number of Subjects Seroconverted to HI Antibodies
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Number of Subjects Seroprotected Against HI Antibodies
A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Seroconversion Factor for HI Antibodies
The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00778895
Brief Title
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
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 10, 2008 (undefined)
Primary Completion Date
August 19, 2009 (Actual)
Study Completion Date
August 19, 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Flu, Safety, Immunogenicity, Flu vaccine, Influenza, Virus
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluviral F1 Group
Arm Type
Experimental
Arm Description
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 1 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Arm Title
Fluviral F2 Group
Arm Type
Experimental
Arm Description
Subjects 6 months to 3 years of age received if primed, 1 dose of formulation 2 of Fluviral vaccine at Day 0 and if unprimed, 2 doses of formulation 1 of Fluviral vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Arm Title
Vaxigrip Group
Arm Type
Active Comparator
Arm Description
Subjects 6 months to 3 years of age received if primed, 1 dose of Vaxigrip vaccine at Day 0 and if unprimed, 2 doses of Vaxigrip vaccine at Day 0 and approximately Day 28. The vaccine was administered intramuscularly in the anterolateral part of the thigh (if the subject was less than 12 months) or in the deltoid region of the arm.
Intervention Type
Biological
Intervention Name(s)
GSK Biologicals' influenza vaccine GSK1557482A
Other Intervention Name(s)
Fluviral
Intervention Description
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).
Intervention Type
Biological
Intervention Name(s)
Vaxigrip
Intervention Description
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).
Primary Outcome Measure Information:
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm). This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 4-day follow-up period (Days 0-3) after any vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Description
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 4-day follow-up period (Days 0-3) after any vaccination
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Description
Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination. This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 28-day follow-up period (Days 0-27) after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Description
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 28-day post-vaccination period
Title
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Description
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 6-month safety follow up after vaccination
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 28-day post-vaccination period
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This primary outcome measure was assessed for Fluviral F1 Group and Fluviral F2 Group respectively as per the study protocol.
Time Frame
During the 6-month safety follow up after vaccination
Secondary Outcome Measure Information:
Title
Titers for Serum Hemagglutination Inhibition (HI) Antibodies
Description
Titers are presented as geometric mean titers (GMTs). The reference cut-off value was the seropositivity cut-off of 1:10. Antibodies assessed were antibodies against the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida flu strains.
Time Frame
At Day 0 [PRE] and at Day 28 (for primed subjects) and Day 56 (for unprimed subjects) [POST]
Title
Number of Subjects Seroconverted to HI Antibodies
Description
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer < 1:10 and a post-vaccination titer ≥1:40, or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time Frame
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Title
Number of Subjects Seroprotected Against HI Antibodies
Description
A seroprotected subject was defined as a vaccinated subject with serum HI titer ≥ 1:40.
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time Frame
At Day 0 [PRE] and at Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Title
Seroconversion Factor for HI Antibodies
Description
The seroconversion factor (SCF) was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination (at Day 28 for primed subjects and at Day 56 for unprimed subjects) compared to pre-vaccination (Day 0).
The flu strains assessed were the A/Brisbane (H1N1), A/Uruguay (H3N2) and B/Florida.
Time Frame
At Day 28 (for primed subjects) and at Day 56 (for unprimed subjects) [POST]
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms After Vaccination
Description
Solicited local symptoms assessed were pain, redness and swelling. Any was defined as any solicited local symptom reported regardless of intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling were defined as redness/swelling above 50 millimeters (mm).
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 4-day follow-up period (Days 0-3) after any vaccination
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms After Vaccination
Description
Symptoms assessed were drowsiness, irritability, loss of appetite and fever. Any was defined as occurrence of any general symptom regardless of their intensity grade or relationship to vaccination. Any fever = Axillary temperature ≥ 38.0 degrees Celsius (°C). Grade 3 fever = Axillary temperature ≥ 39.0°C. For other symptoms, grade 3 was defined as an adverse event which prevented normal everyday activities. Related = A general symptom assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 4-day follow-up period (Days 0-3) after any vaccination
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) After Vaccination
Description
Unsolicited AEs covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 = Occurrence of any unsolicited AE that prevented normal, everyday activities. Related = Occurrence of an unsolicited AE assessed by the investigator to be causally related to study vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 28-day follow-up period (Days 0-27) after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Description
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 28-day post-vaccination period after vaccination
Title
Number of Subjects With Any, Grade 3 and Related Medically-attended Adverse Events (MAEs) After Vaccination
Description
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Analysis of intensity and relationship to vaccination of MAEs was not performed.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 6-month safety follow up after vaccination
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 28-day post-vaccination period
Title
Number of Subjects With Any and Related Serious Adverse Events (SAEs) After Vaccination
Description
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any SAE(s) = Occurrence of any SAE(s) regardless of intensity grade or relation to vaccination. Related SAE(s) = Occurrence of any SAE(s) assessed by the investigator as causally related to vaccination.
This secondary outcome measure was assessed for the Vaxigrip Group as per the study protocol.
Time Frame
During the 6-month safety follow up after vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Facility Name
GSK Investigational Site
City
Langley
State/Province
British Columbia
ZIP/Postal Code
V3A 4H9
Country
Canada
Facility Name
GSK Investigational Site
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3P4
Country
Canada
Facility Name
GSK Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 5B6
Country
Canada
Facility Name
GSK Investigational Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
GSK Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 5G8
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
GSK Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6H 4P2
Country
Canada
Facility Name
GSK Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5A 3V4
Country
Canada
Facility Name
GSK Investigational Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 5G8
Country
Canada
Facility Name
GSK Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
GSK Investigational Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1N8
Country
Canada
Facility Name
GSK Investigational Site
City
Charlottetown
State/Province
Prince Edward Island
ZIP/Postal Code
C1A 5N4
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
GSK Investigational Site
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
Facility Name
GSK Investigational Site
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1X 3V7
Country
Canada
Facility Name
GSK Investigational Site
City
Trois Rivières
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23687572
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.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
111635
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
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
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