Back to resultsImmunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Primary Purpose
Infections, Streptococcal
Status
Completed
Phase
Phase 3
Locations
Singapore
Study Type
Interventional
Intervention
Pneumococcal vaccine GSK1024850A
Infanrix-IPV/Hib
Sponsored by
About this trial
This is an interventional prevention trial for Infections, Streptococcal focused on measuring safety, Streptococcus pneumoniae, immunogenicity, Pneumococcal conjugate vaccine, Haemophilus influenzae
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
- Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
- Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
- Written informed consent obtained from the parents/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
- Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
- A family history of congenital or hereditary immunodeficiency.
- Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
- Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
- Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
Fever at the time of vaccination.
- Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
Acute disease at the time of enrolment.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Child in care.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
Arm Description
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Outcomes
Primary Outcome Measures
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Protein D (PD).
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Secondary Outcome Measures
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm).
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).
Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.
Related = solicited symptom assessed by the investigator as causally related to study vaccination.
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
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.
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
Opsonophagocytic activity (OPA) testing was not performed.
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Opsonophagocytic activity (OPA) testing was not performed.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Diphtheria and Tetanus.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Concentrations of Antibodies Against Protein D (PD).
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Concentrations of Antibodies Against Diphtheria and Tetanus.
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01119625
Brief Title
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
Official Title
Evaluation of Immunological Persistence Following 3-dose Priming With GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine in Study NCT00808444 and Safety and Immunogenicity Following a Booster Dose of the Same Vaccine
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
July 12, 2010 (undefined)
Primary Completion Date
February 17, 2011 (Actual)
Study Completion Date
February 17, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
This primary purpose of this study is the evaluation of the immunological persistence following completion of the 3-dose primary vaccination course with either a clinical or a commercial lot of pneumococcal conjugate vaccine GSK1024850A in study NCT00808444. In addition, the study will also assess the safety, reactogenicity and immunogenicity of a fourth dose of pneumococcal conjugate vaccine GSK1024850A (commercial lot) when co-administered with Infanrix-IPV/Hib at 18-21 months of age in children primed in study NCT00808444.
The primary vaccination study was conducted in Malaysia and Singapore. The booster vaccination study will not be performed in Malaysia since the pneumococcal conjugate vaccine GSK1024850A has been registered in September 2009. However, subjects in Malaysia will be offered a booster dose of the commercial pneumococcal conjugate vaccine licensed in Malaysia and Infanrix-IPV/Hib vaccine during the second year of life according to the nationally recommended regimen. Administration of the booster dose will be outside the set-up of a clinical trial. Hence no data will be collected, no blood samples will be taken in Malaysia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Streptococcal
Keywords
safety, Streptococcus pneumoniae, immunogenicity, Pneumococcal conjugate vaccine, Haemophilus influenzae
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
238 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group
Arm Type
Experimental
Arm Description
children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Arm Title
Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group
Arm Type
Active Comparator
Arm Description
children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
Intervention Type
Biological
Intervention Name(s)
Pneumococcal vaccine GSK1024850A
Intervention Description
Intramuscular injection, one dose
Intervention Type
Biological
Intervention Name(s)
Infanrix-IPV/Hib
Intervention Description
Intramuscular injection, one dose
Primary Outcome Measure Information:
Title
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Description
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Time Frame
Before booster vaccination at Month 0
Title
Concentrations of Antibodies Against Protein D (PD).
Description
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Time Frame
Before booster vaccination at Month 0
Secondary Outcome Measure Information:
Title
Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs).
Description
Solicited AEs = AEs to be recorded as endpoints in the clinical study. The presence/occurrence/intensity of these events is actively solicited from the subject or an observer during a specified post-vaccination follow-up period.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade. Grade 3 pain = cried when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling above 30 millimetre (mm).
Time Frame
Within 4 days (Days 0-3) after booster vaccination.
Title
Number of Subjects Reporting Any, Grade 3 and Related Solicited General Adverse Events (AEs).
Description
Solicited general symptoms assessed were drowsiness, irritability, loss of appetite and fever (= axillary temperature equal to or above 37.5 degrees Celsius (°C)).
Any= occurrence of any general symptom regardless of intensity grade or relationship to vaccination Grade 3 drowsiness = drowsiness which prevented normal activity. Grade 3 irritability = crying that could not be comforted/ prevented normal activity. Grade 3 loss of appetite = not eating at all. Grade 3 fever = temperature >39.5°C.
Related = solicited symptom assessed by the investigator as causally related to study vaccination.
Time Frame
Within 4 days (Days 0-3) after booster vaccination.
Title
Number of Subjects Reporting Unsolicited Adverse Events (AEs).
Description
Unsolicited AEs = Any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Time Frame
Within 31 days (Days 0-30) after booster vaccination
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, from the booster vaccination, at Month 0, up to the study end, at Month 1
Title
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes.
Description
Opsonophagocytic activity (OPA) testing was not performed.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A.
Description
Opsonophagocytic activity (OPA) testing was not performed.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Description
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Time Frame
Before booster vaccination at Month 0
Title
Concentrations of Antibodies Against Diphtheria and Tetanus.
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Time Frame
Before booster vaccination at Month 0
Title
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Time Frame
Before booster vaccination at Month 0
Title
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Time Frame
Before booster vaccination at Month 0
Title
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Description
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Time Frame
Before booster vaccination at Month 0
Title
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes.
Description
Vaccine pneumococcal serotypes assessed were serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
Pneumococcal serotype specific total imunoglobuline G (IgG) antibodies were measured by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes.
Description
Cross-reactive pneumococcal serotypes assessed were serotypes 6A and 19A. Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL).
The antibody concentrations against the cross-reactive pneumococcal serotypes 6A and 19A were determined by 22F-inhibition Enzyme-linked immunosorbent assay (ELISA). The cut-off of the assay was 0.05 µg/mL.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Protein D (PD).
Description
Anti-PD antibodies were determined using an ELISA assay. Concentration of specific PD antibodies was determined, using a standard reference serum. The cut-off of the assay is 100 ELISA units per millilitre (EU/mL).
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Diphtheria and Tetanus.
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in International units per millilitre (IU/mL). The cut-off of the assay was 0.1 IU/mL.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN).
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in ELISA units per millilitre (EU/mL). The cut-off of the assay was 5 EU/mL.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Concentrations of Antibodies Against Polyribosyl-ribitol Phosphate (PRP).
Description
Concentrations were expressed as geometric mean concentrations (GMCs) in microgram per millilitre (µg/mL). The cut-off of the assay was 0.15 µg/mL.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
Title
Titers of Antibodies Against Poliovirus Types 1, 2 and 3.
Description
Titers were expresses as geometric mean titers (GMTs). The cut-off of the assay was 8.
Time Frame
Before and one month after booster vaccination (at Month 0 and Month 1)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
21 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
Male or female between, and including, 18 and 21 months of age at the time of booster vaccination.
Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00808444
Written informed consent obtained from the parents/LAR(s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.
Exclusion Criteria:
Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding vaccination, or planned use during the study period.
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
A family history of congenital or hereditary immunodeficiency.
Administration of immunoglobulins and/ or any blood products within the 3 months preceding vaccination or planned use during the study period.
Administration of any pneumococcal and/or vaccine containing diphtheria, tetanus, pertussis, poliomyelitis or Haemophilus influenzae type b antigens since the end of study NCT00808444.
Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before vaccination and ending 30 days after vaccination.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
History of any reaction or allergic disease likely to be exacerbated by any component of the study vaccines.
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures. (Subjects who have had a single uncomplicated febrile convulsion in the past can be included)
Fever at the time of vaccination.
Fever is defined as rectal temperature >= 38.0°C or tympanic/axillary/ oral temperature >= 37.5°C.
Acute disease at the time of enrolment.
Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
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
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Facility Name
GSK Investigational Site
City
Singapore
ZIP/Postal Code
688846
Country
Singapore
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
25278086
Citation
Lim FS, Koh MT, Tan KK, Chan PC, Chong CY, Shung Yehudi YW, Teoh YL, Shafi F, Hezareh M, Swinnen K, Borys D. A randomised trial to evaluate the immunogenicity, reactogenicity, and safety of the 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) co-administered with routine childhood vaccines in Singapore and Malaysia. BMC Infect Dis. 2014 Oct 2;14:530. doi: 10.1186/1471-2334-14-530.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
113266
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
113266
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
113266
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
113266
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
113266
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
113266
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
113266
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Immunological Persistence After Priming With GSK1024850A Vaccine and Safety& Immunogenicity After Booster Dose
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