Back to resultsSafety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Pandemic influenza vaccine GSK2340272A
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring influenza infection, GSK Bio's influenza vaccine GSK2340272A
Eligibility Criteria
Inclusion Criteria:
- Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
- Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
- Written informed consent obtained from the parent(s) or LAR(s) of the subject.
- Healthy children, as established by medical history and clinical examination when entering the study.
- Parent/LAR 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:
- 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.
- Clinically or virologically confirmed influenza infection within six months preceding the study start.
- 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.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
- History of hypersensitivity to vaccines.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
- History of any neurological disorders or seizures.
- Acute disease and/or fever at the time of enrolment
- Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
- Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
- Child in Care.
Sites / Locations
- 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
GSK 2340272A F1 Group
GSK 2340272A F2 Group
Arm Description
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Outcomes
Primary Outcome Measures
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Secondary Outcome Measures
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Titers for Serum Neutralising Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Titers for Serum Neutralising Antibodies
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Number of Subjects With Any Medically-attended Events (MAEs)
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.
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Number of Subjects With Normal/Abnormal Biochemical Levels
Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00971321
Brief Title
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
Official Title
Safety and Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (GSK2340272A) in Children Aged 6 to 35 Months
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 10, 2009 (undefined)
Primary Completion Date
November 24, 2010 (Actual)
Study Completion Date
November 24, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This trial is designed to assess the safety and immunogenicity of a prime-boost schedule of GSK Biologicals' investigational vaccine GSK2340272A in children aged between 6 and 35 months.
This protocol posting has been updated following protocol amendment 4, March 2010. The protocol posting sections impacted are number of subjects, primary and secondary endpoints and intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
influenza infection, GSK Bio's influenza vaccine GSK2340272A
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
157 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK 2340272A F1 Group
Arm Type
Experimental
Arm Description
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 1 (F1) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Arm Title
GSK 2340272A F2 Group
Arm Type
Experimental
Arm Description
Healthy male or female children, between and including 6 and 35 months of age, who received 2 doses of GSK2340272A Formulation 2 (F2) vaccine according to a 0, 21-day schedule, intramuscularly administered in the deltoid region of the arm or in the anterolateral region of the thigh if the subject was less than (<) 12 months at study entry.
Intervention Type
Biological
Intervention Name(s)
Pandemic influenza vaccine GSK2340272A
Intervention Description
Two primary intramuscular (IM) injections
Primary Outcome Measure Information:
Title
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 0
Title
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 42
Title
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 0
Title
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 42
Title
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 42
Title
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 42
Title
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Description
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Day 42
Secondary Outcome Measure Information:
Title
Number of Seropositive Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seropositivity was defined as H1N1 HI antibody titers greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Days 0, 21, 42, and at Month 11-12
Title
Titers for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:10. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Days 0, 21, 42 and at Month 11-12
Title
Number of Seroconverted Subjects in Terms of H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Description
Seroconversion (SCR) was defined as the percentage of vaccinees that have 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 4-fold increase in post-vaccination titer. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Days 21, 42 and at Month 11-12
Title
Number of Seroprotected Subjects for H1N1 Haemagglutination Inhibition (HI) Antibodies
Description
Seroprotection (SPR) was defined as the percentage of vaccinees with a serum HI titer ≥ 1:40 that usually is accepted as indicating protection. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Days 0, 21, 42 and at Month 11-12
Title
Seroconversion Factor (SCF) for H1N1 Haemagglutination Inhibition (HI) Antibody Titers
Description
Seroconversion factor was defined as the fold increase in serum HI geometric mean titers (GMTs) post-vaccination compared to pre-vaccination. The strain assessed was Flu A/California/7/2009 (H1N1).
Time Frame
At Days 21, 42 and at Month 11-12
Title
Titers for Serum Neutralising Antibodies
Description
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Time Frame
At Days 0, 21 and 42
Title
Titers for Serum Neutralising Antibodies
Description
Antibody titers are presented as geometric mean titers (GMTs), with a reference seropositivity cut-off value greater than or equal to (≥) 1:8. The strain assessed was Flu A/Neth/602/09.
Time Frame
At Days 0, 21, 42 and at Month 11-12
Title
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Description
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Time Frame
At Days 21 and 42
Title
Number of Subjects With Vaccine Response for Serum Neutralising Antibodies
Description
Vaccine response rate was defined as the percentage of vaccinees with a minimum 4-fold increase in titer at post-vaccination for neutralising antibody response. For initially seronegative subjects, antibody titer ≥ 1:32 after vaccination; For initially seropositive subjects, antibody titer after vaccination ≥ 4 fold the pre-vaccination antibody titer. The strain assessed was Flu A/Neth/602/2009.
Time Frame
At Days 21, 42 and at Month 11-12
Title
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Description
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Time Frame
During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Description
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade or relationship to vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 loss of appetite= not eating at all. Grade 3 fever = fever > 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time Frame
During the 7-day (Days 0-6) post-vaccination period after each dose and across doses
Title
Number of Subjects With Any Medically-attended Events (MAEs)
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.
Time Frame
During the entire study period (Day 0 up to Month 7 and Day 0 up to Month 11-12)
Title
Number of Subjects With Any Adverse Events of Specific Interest (AESIs)/ Potential Immune-mediated Disease (pIMDs)
Description
An AESI was defined as an AE including autoimmune diseases and other mediated inflammatory disorders and assessed by the investigator as specific to the treatment administration. Potential immune-mediated diseases (pIMDs) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame
During the entire study period (Day 0 up to Month 11-12)
Title
Number of Subjects With Normal/Abnormal Biochemical Levels
Description
Among biochemical parameters assessed were: alanine aminotrasferase [ALAT], aspartate aminotransferase [ASAT], bilirubin total [BIL/T], bilirubin direct [BIL/D], creatinine [CREA] and blood urea nitrogen [BUN]. Levels of biochemical parameters assessed with respect to normal laboratory values were - unknown, below, within and above.
Time Frame
At Days 0, 21 and 42
Title
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs)
Description
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and 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 the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities. Related = AE assessed by the investigator as related to the vaccination.
Time Frame
During a 21 day follow-up period after the first vaccination and during a 62-day follow-up period after the second vaccination (Days 0 - 84)
Title
Number of Subjects With Serious Adverse Events (SAEs)
Description
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time Frame
During the entire study period (Day 0 up to Month 11-12)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
35 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
Children, male or female, aged between 6 and 35 months at the time of first study vaccination.
Written informed consent obtained from the parent(s) or LAR(s) of the subject.
Healthy children, as established by medical history and clinical examination when entering the study.
Parent/LAR 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:
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.
Clinically or virologically confirmed influenza infection within six months preceding the study start.
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.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
Acute or chronic, clinically-significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by medical history and physical examination.
History of hypersensitivity to vaccines.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccines
History of any neurological disorders or seizures.
Acute disease and/or fever at the time of enrolment
Administration of immunoglobulins and/or any blood products within the three months prior to the enrolment in this study, or planned during the study.
Any condition which, in the opinion of the investigator, renders the subject unfit for participation in the study.
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
Bilbao
ZIP/Postal Code
48013
Country
Spain
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
GSK Investigational Site
City
Móstoles/Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
GSK Investigational Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
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
26176592
Citation
Garcia-Sicilia J, Aristegui J, Omenaca F, Carmona A, Tejedor JC, Merino JM, Garcia-Corbeira P, Walravens K, Bambure V, Moris P, Caplanusi A, Gillard P, Dieussaert I. Safety and persistence of the humoral and cellular immune responses induced by 2 doses of an AS03-adjuvanted A(H1N1)pdm09 pandemic influenza vaccine administered to infants, children and adolescents: Two open, uncontrolled studies. Hum Vaccin Immunother. 2015;11(10):2359-69. doi: 10.1080/21645515.2015.1063754.
Results Reference
derived
PubMed Identifier
20600478
Citation
Carmona A, Omenaca F, Tejedor JC, Merino JM, Vaman T, Dieussaert I, Gillard P, Aristegui J. Immunogenicity and safety of AS03-adjuvanted 2009 influenza A H1N1 vaccine in children 6-35 months. Vaccine. 2010 Aug 16;28(36):5837-44. doi: 10.1016/j.vaccine.2010.06.065. Epub 2010 Jun 29.
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
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113462
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
113462
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
113462
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
113462
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
113462
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
113462
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113462
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Safety, Immunogenicity Study of GSK Biologicals' Pandemic Influenza Candidate Vaccine (H1N1) (GSK2340272A)
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