Back to resultsImmunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fluarix Quadrivalent
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring GSK Biologicals quadrivalent influenza vaccine, Influenza, Children, Safety, Immunogenicity
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
- Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Child in care.
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
- Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
- Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
- Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
- History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
- Any contraindication to intramuscular injection.
Acute disease and/or fever at the time of enrollment:
- Fever is defined as temperature ≥ 37.5°C by any route.
- Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
- Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
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
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
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- 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 Type
Experimental
Experimental
Arm Label
Fluarix Quadrivalent Primed Group
Fluarix Quadrivalent Unprimed Group
Arm Description
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
Outcomes
Primary Outcome Measures
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Secondary Outcome Measures
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Duration of Solicted Symptoms
Duration was defined as number of days with any grade of solicted local and/or general symptoms
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
Unsolicited AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01702454
Brief Title
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
Official Title
Immunogenicity, Safety and Reactogenicity Study of GSK Biologicals' Quadrivalent Seasonal Influenza Candidate Vaccine GSK2321138A, Administered to Children Who Previously Participated in Study 115345
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 6, 2012 (undefined)
Primary Completion Date
May 6, 2013 (Actual)
Study Completion Date
June 5, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess the safety and immunogenicity of GSK Biologicals' investigational vaccine GSK2321138A in children who previously participated in study 115345 (FLU D-QIV-004 PRI) (NCT01439360).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
GSK Biologicals quadrivalent influenza vaccine, Influenza, Children, Safety, Immunogenicity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
470 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluarix Quadrivalent Primed Group
Arm Type
Experimental
Arm Description
Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
Arm Title
Fluarix Quadrivalent Unprimed Group
Arm Type
Experimental
Arm Description
Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
Intervention Type
Biological
Intervention Name(s)
Fluarix Quadrivalent
Intervention Description
1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status
Primary Outcome Measure Information:
Title
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Number of Seropositive Subjects Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer below 1:10 and a post-vaccination titer ≥ 1:40 or a pre-vaccination titer ≥ 1:10 and at least a 4-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Number of Subjects Seroprotected for Anti-HA Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
Seroprotection rate (SPR) was defined as the number of vaccinees with serum haemagglutination inhibition (HI) titer ≥ 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Serum Hemagglutination Inhibition (HI) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Number of Subjects Seropositive for HI Antibody Titers Against Each of the Four Vaccine Strains After Dose 1 of Fluarix Quadrivalent Vaccine
Description
Seropositivity was defined as number of subjects with antibody titers greater than or equal to (≥) 1:10. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Number of Subjects Seroconverted for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
A seroconverted subject was defined as a subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer greater than or equal to 1:40 or a pre-vaccination titer greater than or equal to 1:10 and at least a four-fold increase in post-vaccination titer. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata )antigens.
Time Frame
At Day 7 post dose 1
Title
Mean Geometric Increase (MGI) for HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
Mean geometric increase was defined as the geometric mean of the within subject ratios of the post-vaccination reciprocal HI titer to the Day 0 reciprocal HI titer. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Number of Subjects Seroprotected for HI Antibodies Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
Seroprotection rate was defined as the number of vaccinees with a serum HI titer greater than or equal to(≥) 1:40 that usually is accepted as indicating protection in adults. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008 (Victoria)and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Secondary Outcome Measure Information:
Title
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40 and ≥ 1:40. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
Antibody titers were expressed as Geometric mean titers (GMTs). The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
Antibody titers were expressed as GMTs. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Vaccine Response Rate (VRR) for Neutralising Antibody Titers Against Each of the Four Vaccine Strains.
Description
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains.
Description
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
MGI was defined as the fold increase in serum HI GMT post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Number of Subjects With HI Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
The cut-off values assessed were less than (<) 1:10, 1:10 to < 1:40,≥ 1:40, ≥1:60 and ≥1:80 . The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Serum Micro Neutralizing(MN) Antibody Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
MN antibody titers were expressed as geometric mean titers(GMTs). The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
NI (Neuraminidase inhibitor) antibody titers were expressed as geometric mean titers(GMTs).The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 0 and Day 7
Title
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains
Description
VRR was defined as the number of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine.
Description
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibodies Against Each of the Four Vaccine Strains.
Description
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 ( H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine
Description
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.
Time Frame
At Day 7 post dose 1
Title
Serum Neutralising Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Description
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010 (H1N1),A/Victoria/361/2011 (H3N2), A/Victoria/361/2011 and B/Hubei-Wujiagang/158/2009)(Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 0 and Day 7
Title
Serum Anti-neuraminidase Antibody Titers Against Each of the Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Description
Antibody titers were expressed as geometric mean titers. The vaccine strains included A/Christchurch/16/2010(H1N1), A/Victoria/361/2011(H3N2),B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009(Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 0 and Day 7
Title
Vaccine Response Rate(VRR) for Serum Neutralising Antibody Titers Against Each of the Four Vaccine Strains by Age Strata
Description
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011(H3N2), B/Brisbane/60/2008(Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 7 post dose 1
Title
MGI for Neutralising Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata
Description
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0.The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens.The humoral response in terms of neutralising antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 7 post dose 1
Title
Vaccine Response Rate(VRR) for Anti-neuraminidase Antibody Titers Against Each of the Four Vaccine Strains by Age Strata.
Description
VRR was defined as the percentage of vaccinees who had either a pre-vaccination titer <cut-off and a post-vaccination titer ≥ 4-fold of half of the cut-off or a pre-vaccination titer ≥cut-off and at least a 4-fold increase in post-vaccination titers. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria /361/2011(H3N2), B/Brisbane /60/2008(Victoria ) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 7 post dose 1
Title
MGI for Anti-neuraminidase Antibodies Titers Against Each of the Four Vaccine Strains After 1 Dose of Fluarix Quadrivalent Vaccine by Age Strata.
Description
MGI was defined as the fold increase in GMTs post-vaccination compared to Day 0. The vaccine strains included A/Christchurch/16/2010 (H1N1), A/Victoria/361/2011 (H3N2), B/Brisbane/60/2008 (Victoria) and B/Hubei-Wujiagang/158/2009 (Yamagata) antigens. The humoral response in terms of anti-neuraminidase antibodies for all vaccine strains were calculated by age stratum which included 17-29 months and 30-48 months age groups for both the Fluarix primed and unprimed groups.
Time Frame
At Day 7 post dose 1
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs)
Description
Solicited local AEs assessed were pain, redness and swelling. Any = any solicited local AE reported irrespective of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness and swelling was defined as redness/swelling above 50 millimeter (mm).
Time Frame
During a 7-day (Day 0 to 6) follow-up period after first vaccination
Title
Duration of Solicted Symptoms
Description
Duration was defined as number of days with any grade of solicted local and/or general symptoms
Time Frame
During the 7-day (Days 0-6) post-vaccination Dose 1 period
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Symptoms.
Description
Solicited general symptoms assessed were drowsiness, Irritability/Fussiness, loss of appetite and Temperature. Any Temperature = axillary temperature ≥37.5 degrees Celsius (°C). Any = any solicited general symptom reported irrespective of intensity and relationship to vaccination. Related = symptoms considered by the investigator to have a causal relationship to vaccination. Grade 3 symptoms = symptoms that prevented normal activity. Grade 3 Irritability/Fussiness = Crying that could not be comforted/prevented normal activity. Grade 3 loss of appetite = did not eat at all. Grade 3 temperature = axillary temperature > 39.0°C.
Time Frame
During the 7 days (Days 0 - 6) post dose 1 vaccination
Title
Number of Subjects Reporting AEs With Medically Attended Visits (MAV)
Description
MAVs were defined as an AEs with a medically-attended visits i.e. prompting emergency room (ER) visits, hospitalizations or physician visits and that were not routine visits for physical examination or vaccination. Any MAV was defined as at least one MAV experienced. Grade 3 was a MAV that prevented normal activities and related was defined as a MAV assessed by the investigator to be causally related to the study vaccination.
Time Frame
During the entire study period (Day 0 - Day 179)
Title
Number of Subjects Reporting Potential Immune-Mediated Diseases (pIMDs)
Description
pIMDs were defined as a subset of AEs that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune aetiology. Any pIMDs= Any AEs that occured regardless of the relation with vaccination. Related pIMDs= Any pIMD assessed by the investigator as casually related to the study vaccination.
Time Frame
During the entire study period (Days 0 - 179)
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs.
Description
Unsolicited AE 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 was defined as occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination. Grade 3 was an event that prevented normal activities and related was defined as an unsolicited AE assessed by the investigator to be causally related to the study vaccination.
Time Frame
Within 28 days (Days 0-27) after first vaccination
Title
Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)
Description
A serious adverse event was any untoward medical occurrence that: resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any was defined as occurrence of any symptom regardless of intensity grade or relation to vaccination and related was an event assessed by the investigator as causally related to the study vaccination.
Time Frame
During the entire study period (Day 0 - Day 179)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Months
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that parent(s)/LAR(s) can and will comply with the requirements of the protocol.
Children, male or female who received a 2-dose vaccination in the study 115345 (NCT01439360).
Written informed consent obtained from the parent(s)/LAR(s) of the subject.
Subjects in stable health as determined by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Child in care.
Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Since the start of study 115345 (NCT01439360), receipt of any seasonal influenza vaccine other than the study vaccines of study 115345 or planned administration of any influenza vaccine other than the study vaccine during the study.
Administration of any vaccine not foreseen by the study protocol within 4 weeks preceding the first dose of study vaccine or planned use until Visit 2.
Laboratory confirmed influenza infection outside of the 115345 (NCT01439360) study.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to enrolment in the study or planned administration during the study period. Inhaled and topical steroids are allowed.
Administration of immunoglobulins and/ or any blood products within 3 months preceding the first dose of study vaccine or planned administration during the study period.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine.
Any contraindication to intramuscular injection.
Acute disease and/or fever at the time of enrollment:
Fever is defined as temperature ≥ 37.5°C by any route.
Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory infection) without fever may be enrolled at the discretion of the investigator.
Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.
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
Decin
ZIP/Postal Code
405 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
37701
Country
Czechia
Facility Name
GSK Investigational Site
City
Lipnik nad Becvou
ZIP/Postal Code
75131
Country
Czechia
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Odolena voda
ZIP/Postal Code
25070
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava - Poruba
ZIP/Postal Code
70800
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
1600
Country
Czechia
Facility Name
GSK Investigational Site
City
Tabor
ZIP/Postal Code
390 02
Country
Czechia
Facility Name
GSK Investigational Site
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-018
Country
Poland
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
GSK Investigational Site
City
Antequera/Málaga
ZIP/Postal Code
29200
Country
Spain
Facility Name
GSK Investigational Site
City
Blanes (Girona)
ZIP/Postal Code
17300
Country
Spain
Facility Name
GSK Investigational Site
City
Castellón
ZIP/Postal Code
12004
Country
Spain
Facility Name
GSK Investigational Site
City
Castellón
ZIP/Postal Code
12530
Country
Spain
Facility Name
GSK Investigational Site
City
Centelles (Barcelona)
ZIP/Postal Code
08540
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Paiporta, Valencia
ZIP/Postal Code
46200
Country
Spain
Facility Name
GSK Investigational Site
City
Quart De Poblet, Valencia
ZIP/Postal Code
46930
Country
Spain
Facility Name
GSK Investigational Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46011
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46024
Country
Spain
Facility Name
GSK Investigational Site
City
St Austell
State/Province
Cornwall
ZIP/Postal Code
PL26 7RL
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Coventry
State/Province
Warwickshire
ZIP/Postal Code
CV6 4DD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT7 2EB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bristol
ZIP/Postal Code
BS2 8AE
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Gloucester
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
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
30325891
Citation
Claeys C, Chandrasekaran V, Garcia-Sicilia J, Prymula R, Diez-Domingo J, Brzostek J, Mares-Bermudez J, Martinon-Torres F, Pollard AJ, Ruzkova R, Carmona Martinez A, Ulied A, Miranda Valdivieso M, Faust SN, Snape MD, Friel D, Ollinger T, Soni J, Schuind A, Li P, Innis BL, Jain VK. Anamnestic Immune Response and Safety of an Inactivated Quadrivalent Influenza Vaccine in Primed Versus Vaccine-Naive Children. Pediatr Infect Dis J. 2019 Feb;38(2):203-210. doi: 10.1097/INF.0000000000002217.
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
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116023
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
116023
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
116023
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
116023
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
116023
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
116023
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
116023
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Influenza Vaccine When Administered in Children Who Previously Participated in Study 115345
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