Back to resultsImmunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Primary Purpose
Influenza
Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
FluarixTM
HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza, Pandemrix, H1N1, Fluarix
Eligibility Criteria
Inclusion Criteria:
- Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
- Subjects having received Pandemrix at least six months prior to study enrolment.
- Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
- Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
- Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device
Exclusion Criteria:
- Active participation in other clinical trials.
- Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
- Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
- Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
- Acute disease and/or fever at the time of enrolment:
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
- Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
- History of seizures or progressive neurological disease.
- Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
- If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
- Child in care.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fluarix Group
Havrix Group
Arm Description
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Outcomes
Primary Outcome Measures
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Day 28 data were presented only for the Fluarix Group.
Titres were expressed as geometric mean antibody titre.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data was presented only for the Fluarix Group.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Secondary Outcome Measures
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Titres were expressed as geometric mean antibody titres (GMTs).
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data were presented for the Fluarix Group only.
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only.
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Titres were expressed as geometric mean antibody titres (GMTs).
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.
Number of Days With Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Number of Days With Grade 3 Solicited Local Symptoms.
Solicited local symptoms assessed were pain and swelling.
Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Number of Days With Any Solicited General Symptoms.
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Number of Days With Grade 3 Solicited General Symptoms.
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.
Grade 3 symptom = general symptom that prevented normal activity.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Number of Subjects Reporting Medically-attended Events (MAEs).
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Number of Subjects Reporting Medically-attended Events (MAEs).
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Number of Subjects Reporting Adverse Events of Special Interest.
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Number of Subjects Reporting Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01190215
Brief Title
Immunogenicity and Safety Study of FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
Official Title
Immunogenicity and Safety Study of GSK Biologicals' Seasonal (2010-2011) Influenza Vaccine FluarixTM in Adolescents Previously Vaccinated With GSK Biologicals' H1N1 Vaccine PandemrixTM
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
October 4, 2010 (undefined)
Primary Completion Date
July 7, 2011 (Actual)
Study Completion Date
July 7, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This study is designed to assess the immunogenicity, reactogenicity and safety following vaccination with GSK Biologicals' FluarixTM vaccine in children who have previously been vaccinated with one dose of PandemrixTM at the age of 10-17 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Pandemrix, H1N1, Fluarix
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluarix Group
Arm Type
Experimental
Arm Description
Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Arm Title
Havrix Group
Arm Type
Active Comparator
Arm Description
Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
Intervention Type
Biological
Intervention Name(s)
FluarixTM
Intervention Description
One Intramuscular injection
Intervention Type
Biological
Intervention Name(s)
HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)
Intervention Description
Two Intramuscular injections
Primary Outcome Measure Information:
Title
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Description
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Day 28 data were presented only for the Fluarix Group.
Titres were expressed as geometric mean antibody titre.
Time Frame
At Day 0 and Day 28
Title
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Description
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data was presented only for the Fluarix Group.
Time Frame
At Day 0 and Day 28
Title
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Description
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 28
Title
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Description
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 0 and Day 28
Title
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against Fluarix Vaccine Containing H1N1 Strain.
Description
Fluarix vaccine strain was Flu A/California/7/2009 (H1N1).
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 28
Secondary Outcome Measure Information:
Title
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Time Frame
At Day 0 and Day 28
Title
Geometric Mean Antibody Titres for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Titres were expressed as geometric mean antibody titres (GMTs).
Time Frame
At Day 0 and at Month 6
Title
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off value equal to or above 1:10.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 0 and Day 28
Title
Number of Seropositive Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
Seropositivity was assessed for subjects with an antibody titre assay cut-off equal to or above 1:10.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Time Frame
At Day 0 and at Month 6
Title
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre less than (< ) 1:10 and a post-vaccination titre greater than or equal to ( ≥) 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 28
Title
Number of Seroconverted Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroconverted subject was a subject who had either a pre-vaccination (Day 0) titre < 1:10 and a post-vaccination titre ≥ 1:40 or a pre-vaccination titre ≥ 1:10 and at least a 4-fold increase in post-vaccination titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Time Frame
At Month 6
Title
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 0 and Day 28
Title
Number of Seroprotected Subjects for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
A seroprotected subject was a subject with a serum HI titre ≥ 1:40 that usually is accepted as indicating protection.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Time Frame
At Day 0 and Month 6
Title
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 28
Title
Mean Geometric Increase (MGI) for Haemagglutination Inhibition (HI) Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Victoria/210/2009 (H3N2) and B/Brisbane/60/2008.
MGI is defined as the geometric mean of the within-subject ratios of the post-vaccination reciprocal HI titre to the pre-vaccination (Day 0) reciprocal HI titre.
Only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Time Frame
At Month 6
Title
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09(H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Titres were expressed as geometric mean antibody titres (GMTs).
Time Frame
At Day 0 and at Day 28
Title
Geometric Mean Antibody Titres for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Description
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Titres were expressed as geometric mean antibody titres (GMTs).
Time Frame
At Day 0 and at Month 6
Title
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Description
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
Day 28 data were presented for the Fluarix Group only.
Time Frame
At Day 28
Title
Number of Seroconverted Subjects for Neutralising Antibodies Against All Fluarix Vaccine Strains.
Description
A seroconverted subject for neutralising antibodies was a subject with a minimum 4-fold increase in titre at post-vaccination.
Fluarix vaccine strains were Flu A/California/7/2009 (H1N1), A/Perth/16/09 (H3N2) and B/Brisbane/60/2008.
At Month 6, only data for the Flu A/California/7/2009 (H1N1) strain were presented for the Havrix Group.
Time Frame
At Month 6
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any solicited local symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Subjects Reporting Any and Grade 3 Solicited General Symptoms.
Description
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Any = occurrence of any solicited general symptom regardless of intensity grade or relation to vaccination. Grade 3 symptom = general symptom that prevented normal activity. Grade 3 temperature = axillary temperature above 39.0 degrees Celsius.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Days With Any Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain, redness and swelling.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Days With Grade 3 Solicited Local Symptoms.
Description
Solicited local symptoms assessed were pain and swelling.
Grade 3 redness/swelling = redness/swelling above 50 millimetres.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Days With Any Solicited General Symptoms.
Description
Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal symptoms, headache, myalgia, shivering, sweating, temperature (temperature = axillary temperature equal to or above 37.5 degrees Celsius).
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Days With Grade 3 Solicited General Symptoms.
Description
Solicited general symptoms assessed were fatigue, gastrointestinal symptoms, headache and myalgia.
Grade 3 symptom = general symptom that prevented normal activity.
Inter-quartile range assessed was the 25th percentile and the 75th percentile.
Time Frame
Within 7 days (Day 0 - Day 6) after vaccination
Title
Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Description
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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.
Grade 3 = event that prevented normal, everyday activities. Related = event assessed by the investigator as causally related to the study vaccination.
Time Frame
Within 28 days (Day 0 - Day 27) after vaccination
Title
Number of Subjects Reporting Medically-attended Events (MAEs).
Description
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame
Within the 28-day (Days 0-27) post-vaccination period
Title
Number of Subjects Reporting Medically-attended Events (MAEs).
Description
For each solicited and unsolicited symptom the subject experienced, the subject was asked if they received medical attention defined as hospitalization, an emergency room visit or a visit to or from medical personnel for any reason.
Time Frame
During the entire study period (Up to Month 6)
Title
Number of Subjects Reporting Adverse Events of Specific Interest (AESIs)/Potential Immune Mediated Diseases (pIMDs).
Description
Potential Immune-Mediated Diseases (pIMDs) or Adverse events of specific interest (AESI), are a subset of AEs that include both clearly autoimmune diseases and also other inflammatory and/or neurologic disorders which may or may not have an autoimmune etiology.
Time Frame
During the entire study period (Up to Month 6)
Title
Number of Subjects Reporting Adverse Events of Special Interest.
Description
Adverse events of special interest for safety monitoring includes both convulsion and anaphylaxis.
Time Frame
During the entire study period (Up to Month 6)
Title
Number of Subjects Reporting Serious Adverse Events (SAEs).
Description
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame
Within the 28-day (Days 0-27) post-vaccination period
Title
Number of Subjects Reporting Serious Adverse Events (SAEs).
Description
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time Frame
During the entire study period (Up to Month 6)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects having previously been immunized with only one single dose of Pandemrix at the age of 10-17 years inclusive.
Subjects having received Pandemrix at least six months prior to study enrolment.
Subjects who the investigator believes that subject and/or parent(s)/Legally Acceptable Representative(s) [LAR(s)] can and will comply with the requirements of the protocol
Written informed consent obtained from the subject/ the parent(s)/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Subjects or Parent(s)/LAR(s) with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device
Exclusion Criteria:
Active participation in other clinical trials.
Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
Planned administration of any vaccine 30 days prior and 30 days after any study vaccine administration.
Chronic administration of immunosuppressants or other immune-modifying drugs within three months prior to enrolment in this study or planned administration during the study period.
Acute disease and/or fever at the time of enrolment:
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned use during the study.
Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination
Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
History of seizures or progressive neurological disease.
Subjects having received an H1N1v pandemic vaccine other than Pandemrix or having received the 2010/2011 seasonal influenza vaccine.
If the subject is female and if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for two months after completion of the vaccination series.
Child in care.
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
Tampere
ZIP/Postal Code
33100
Country
Finland
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
26069949
Citation
Vesikari T, Richardus JH, Berglund J, Korhonen T, Flodmark CE, Lindstrand A, Silfverdal SA, Bambure V, Caplanusi A, Dieussaert I, Roy-Ghanta S, Vaughn DW. Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine in Children 6 Months to 17 Years of Age, Previously Vaccinated with an AS03-Adjuvanted A(H1N1)Pdm09 Vaccine: Two Open-label, Randomized Trials. Pediatr Infect Dis J. 2015 Jul;34(7):774-82. doi: 10.1097/INF.0000000000000709.
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
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
114452
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
114452
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
114452
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
114452
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
114452
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
114452
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 FluarixTM Vaccine in Children Who Have Previously Been Vaccinated With PandemrixTM
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