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| Name | Class |
|---|---|
| The PATH Malaria Vaccine Initiative (MVI) | OTHER |
The purpose of this study is to show the consistency of different lots of a candidate vaccine (257049) against malaria developed by GlaxoSmithKline (GSK) Biologicals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GSK 257049-Lot 1 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
|
| GSK 257049-Lot 2 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
|
| GSK 257049-Lot 3 Group | Experimental | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
|
| GSK 257049-Pilot Group | Experimental | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049) | Biological | 4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-Circumsporozoite (Anti-CS) Antibody Titers | Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers. | One month post-dose 3 (Month 3) |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-hepatitis B (Anti-HB) Antibody Concentrations | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | One month post-dose 3 (Month 3) |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Enugu | Nigeria | ||||
| GSK Investigational Site |
Not provided
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 113398 | Dataset Specification | View IPD |
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Out of the 327 subjects originally enrolled, 7 dropped out of the study before receiving the first vaccination.
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| ID | Title | Description |
|---|---|---|
| FG000 | GSK 257049-Lot 1 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| FG001 | GSK 257049-Lot 2 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| FG002 | GSK 257049-Lot 3 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| FG003 | GSK 257049-Pilot Group | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | GSK 257049-Lot 1 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Anti-Circumsporozoite (Anti-CS) Antibody Titers | Antibody titers are presented as geometric mean titers (GMTs) and are measured in titers. | The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | Titers | One month post-dose 3 (Month 3) |
|
Solicited local/general symptoms: during the 7-day (Days 0-6) post-vaccination period. Unsolicited AEs: during the 30-day (Days 0-29) post-vaccination period. SAEs: during the entire study period (Day 0 - Month 8).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GSK 257049-Lot 1 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine from the commercial scale lot 1 (formulation 1 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaria | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D008288 | Malaria |
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
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|
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. |
| Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, 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 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses |
| Number of Subjects With Unsolicited Adverse Events | 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. | Within the 30-day (Days 0-29) post-vaccination period |
| Number of Subjects With Serious Adverse Events | 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. | Up to 8 months post-dose 1 |
| Jos |
| Nigeria |
For additional information about this study please refer to the GSK Clinical Study Register |
| 113398 | Statistical Analysis Plan | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113398 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113398 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113398 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 113398 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| Migrated/moved from study area |
|
| Lost to Follow-up |
|
| GSK 257049-Lot 2 Group |
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| BG002 | GSK 257049-Lot 3 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| BG003 | GSK 257049-Pilot Group | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| BG004 | Total | Total of all reporting groups |
| Months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| GSK 257049-Lot 2 Group |
Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| OG002 | GSK 257049-Lot 3 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
| OG003 | GSK 257049-Pooled Group | This is a pooled group, made up of GSK 257049-Lot 1 Group, GSK 257049-Lot 2 Group and GSK 257049-Lot 3 Group. |
| OG004 | GSK 257049-Pilot Group | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. |
|
|
|
| Secondary | Anti-hepatitis B (Anti-HB) Antibody Concentrations | Antibody concentrations are presented as geometric mean concentrations (GMCs) and expressed in milli-international units per milliliter (mIU/mL). | The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | One month post-dose 3 (Month 3) |
|
|
|
| Secondary | 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 = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site. | The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | Count of Participants | Participants | Over a 7-day (Days 0-6)post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Assessed solicited general symptoms were drowsiness, irritability, loss of appetite, 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 loss of appetite = not eating at all. Grade 3 irritability = crying that could not be comforted/prevented normal activity. Grade 3 drowsiness = drowsiness that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. | The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects with their symptom sheets filled in, for whom data were available. | Posted | Count of Participants | Participants | Over a 7-day (Days 0-6) post-vaccination period after each dose and across doses |
|
|
|
| Secondary | Number of Subjects With Unsolicited Adverse Events | 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. | The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Within the 30-day (Days 0-29) post-vaccination period |
|
|
|
| Secondary | Number of Subjects With Serious Adverse Events | 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. | The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data were available. | Posted | Count of Participants | Participants | Up to 8 months post-dose 1 |
|
|
|
| 0 |
| 81 |
| 6 |
| 81 |
| 77 |
| 81 |
| EG001 | GSK 257049-Lot 2 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 2 (formulation 2 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. | 0 | 79 | 5 | 79 | 71 | 79 |
| EG002 | GSK 257049-Lot 3 Group | Healthy male or female children aged 5 to 17 months received 3 doses of the GSK 257049 vaccine, from the commercial scale lot 3 (formulation 3 of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. | 0 | 80 | 12 | 80 | 71 | 80 |
| EG003 | GSK 257049-Pilot Group | Healthy male or female children aged 5 to 17 received 3 doses of the GSK 257049 vaccine from the pilot scale (pilot formulation of the GSK 257049 vaccine) administered intramuscularly (IM) in the deltoid of the left arm, at Day 0, at Month 1 and at Month 2. | 0 | 80 | 4 | 80 | 67 | 80 |
| Malaria | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Tonsillitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Malnutrition | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
|
| Pneumonitis chemical | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Bronchopneumonia | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Enteritis | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Furuncle | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Redness | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Swelling | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Drowsiness | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Irritability | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Loss of appetite | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Fever (axillary) | General disorders | MedDRA 15.0 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D000079426 |
| Vector Borne Diseases |
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| Grade 3 Pain, Dose 1 |
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| Any Redness, Dose 1 |
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| Grade 3 Redness, Dose 1 |
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| Any Swelling, Dose 1 |
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| Grade 3 Swelling, Dose 1 |
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| Any Pain, Dose 2 |
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| Grade 3 Pain, Dose 2 |
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| Any Redness, Dose 2 |
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| Grade 3 Redness, Dose 2 |
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| Any Swelling, Dose 2 |
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| Grade 3 Swelling, Dose 2 |
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| Any Pain, Dose 3 |
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| Grade 3 Pain, Dose 3 |
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| Any Redness, Dose 3 |
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| Grade 3 Redness, Dose 3 |
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| Any Swelling, Dose 3 |
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| Grade 3 Swelling, Dose 3 |
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| Any Pain, Across Doses |
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| Grade 3 Pain, Across Doses |
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| Any Redness, Across Doses |
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| Grade 3 Redness, Across Doses |
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| Any Swelling, Across Doses |
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| Grade 3 Swelling, Across Doses |
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| Related Drowsiness, Dose 1 |
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| Grade 3 Drowsiness, Dose 1 |
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| Any Irritability, Dose 1 |
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| Related Irritability, Dose 1 |
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| Grade 3 Irritability, Dose 1 |
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| Any Loss of appetite, Dose 1 |
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| Any Fever, Dose 1 |
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| Related Fever, Dose 1 |
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| Grade 3 Fever, Dose 1 |
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| Any Drowsiness, Dose 2 |
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| Related Drowsiness, Dose 2 |
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| Grade 3 Drowsiness, Dose 2 |
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| Any Irritability, Dose 2 |
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| Any Loss of appetite, Dose 2 |
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| Any Fever, Dose 2 |
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| Grade 3 Fever, Dose 2 |
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| Any Drowsiness, Dose 3 |
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| Related Drowsiness, Dose 3 |
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| Any Irritability, Dose 3 |
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| Related Irritability, Dose 3 |
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| Grade 3 Irritability, Dose 3 |
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| Any Loss of appetite, Dose 3 |
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| Grade 3 Loss of appetite, Dose 3 |
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| Any Fever, Dose 3 |
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| Related Fever, Dose 3 |
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| Grade 3 Fever, Dose 3 |
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| Any Drowsiness, Across doses |
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| Related Drowsiness, Across doses |
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| Grade 3 Drowsiness, Across doses |
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| Any Irritability, Across doses |
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| Related Irritability, Across doses |
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| Grade 3 Irritability, Across doses |
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| Any Loss of appetite, Across doses |
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| Related Loss of appetite, Across doses |
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| Grade 3 Loss of appetite, Across doses |
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| Any Fever, Across doses |
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| Related Fever, Across doses |
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| Grade 3 Fever, Across doses |
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