Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
Official Title
A Partially-blind (Observer-blind) Study to Evaluate the Safety and Immunogenicity of 3 Different Vaccination Schedules With 2 GSK Biologicals' Candidate Plasmodium Falciparum Vaccines in Children Aged 5 to 17 Months Living in Ghana
Acronym
Not provided
Organization
GlaxoSmithKlineINDUSTRY
Status Module
Record Verification Date
Aug 2017
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Aug 30, 2006Actual
Primary Completion Date
Aug 25, 2007Actual
Completion Date
May 30, 2008Actual
First Submitted Date
Jul 31, 2006
First Submission Date that Met QC Criteria
Aug 3, 2006
First Posted Date
Aug 4, 2006Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 4, 2017
Results First Submitted that Met QC Criteria
Aug 10, 2017
Results First Posted Date
Feb 19, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Sep 3, 2009
Certification/Extension First Submitted that Passed QC Review
Sep 3, 2009
Certification/Extension First Posted Date
Sep 4, 2009Estimated
Last Update Submitted Date
Aug 10, 2017
Last Update Posted Date
Feb 19, 2018Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
GlaxoSmithKlineINDUSTRY
Collaborators
Not provided
Oversight Module
No data available
No data is available for this block.
Description Module
Brief Summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
Conditions Module
Conditions
Malaria
Keywords
Vaccine
Prophylaxis Plasmodium falciparum malaria
Plasmodium falciparum
Malaria
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
540Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
SB257049 F2 0-1 M Group
Experimental
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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.
From Day 0 to Month 10
Secondary Outcomes
Measure
Description
Time Frame
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
A male or female child between 5 months and 17 months of age at the time of first vaccination.
Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child.
Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Exclusion Criteria:
Acute disease at the time of enrolment.
Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period.
Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
Simultaneous participation in any other clinical trial;
Previous participation in any other malaria vaccine trial;
Any twins
History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Not provided
Recruitment Details
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG004
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG005
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
FG006
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
FG00090 subjects
FG00190 subjects
FG00245 subjects
FG00390 subjects
FG00490 subjects
FG00590 subjects
FG00645 subjects
COMPLETED
FG00084 subjects
FG00187 subjects
FG00242 subjects
FG00388 subjects
FG004
NOT COMPLETED
FG0006 subjects
FG0013 subjects
FG0023 subjects
FG0032 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0001 subjects
FG0011 subjects
FG0020 subjects
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG001
SB257049 F1 0-1 M Group
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
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
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.
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.
Posted
Count of Participants
Participants
From Day 0 to Month 10
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
Adverse Events Module
Frequency Threshold
5
Time Frame
Solicited local/general symptoms: during the 7-day post-vaccination period (Days 0-6); Unsolicited AEs: during the 30-day post-vaccination period (Days 0-29); SAEs: during the entire study period (Day 0 - Month 19).
Description
Not provided
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Biological: Rabipur
SB257049 F1 0-1 M Group
SB257049 F1 0-1-2 M Group
SB257049 F1 0-1-7 M Group
SB257049 F2 0-1 M Group
SB257049 F2 0-1-2 M Group
SB257049 F2 0-1-7 M Group
RTS
S vaccine
Rabipur
Biological
3-dose intramuscular injection.
Rabipur 0-1-2 M Group
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Number of Subjects With Any 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.
During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
At Day 0, at Month 2, at Month 7 and at Month 10
Titers for Anti-Hepatitis B (Anti-HBs)
Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).
At Day 0 and at Month 2
Kumasi
Ghana
Background
Owusu-Agyei S, Ansong D, Asante K, Kwarteng Owusu S, Owusu R, Wireko Brobby NA, Dosoo D, Osei Akoto A, Osei-Kwakye K, Adjei EA, Boahen KO, Sylverken J, Adjei G, Sambian D, Apanga S, Kayan K, Vekemans J, Ofori-Anyinam O, Leach A, Lievens M, Demoitie MA, Dubois MC, Cohen J, Ballou WR, Savarese B, Chandramohan D, Gyapong JO, Milligan P, Antwi S, Agbenyega T, Greenwood B, Evans J. Randomized controlled trial of RTS,S/AS02D and RTS,S/AS01E malaria candidate vaccines given according to different schedules in Ghanaian children. PLoS One. 2009 Oct 2;4(10):e7302. doi: 10.1371/journal.pone.0007302.
For additional information about this study please refer to the GSK Clinical Study Register
For additional information about this study please refer to the GSK Clinical Study Register
85 subjects
FG00586 subjects
FG00643 subjects
5 subjects
FG0054 subjects
FG0062 subjects
1 subjects
FG0041 subjects
FG0051 subjects
FG0060 subjects
Migrated
FG0004 subjects
FG0011 subjects
FG0023 subjects
FG0031 subjects
FG0044 subjects
FG0051 subjects
FG0061 subjects
Other
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
Protocol Violation
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0060 subjects
Death
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0051 subjects
FG0061 subjects
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
BG007
Total
Total of all reporting groups
90
BG00190
BG00245
BG00390
BG00445
BG00590
BG00690
BG007540
Standard Deviation
Months
Title
Denominators
Categories
ParticipantsBG00090
ParticipantsBG00190
ParticipantsBG00245
ParticipantsBG00390
ParticipantsBG00445
ParticipantsBG00590
ParticipantsBG00690
ParticipantsBG007540
Title
Measurements
BG00010.5± 3.4
BG00110.4± 3.4
BG00211.2± 3.3
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG00090
ParticipantsBG00190
ParticipantsBG00245
ParticipantsBG00390
ParticipantsBG00445
ParticipantsBG00590
ParticipantsBG00690
ParticipantsBG007540
Title
Measurements
Female
BG00041
BG00142
BG00223
BG003
Race and Ethnicity Not Collected
Race and Ethnicity were not collected from any participant.
Count of Participants
Participants
Title
Denominators
Categories
ParticipantsBG0000
ParticipantsBG0010
ParticipantsBG0020
ParticipantsBG0030
ParticipantsBG0040
ParticipantsBG0050
ParticipantsBG0060
ParticipantsBG0070
Title
Measurements
BG0070
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG00390
OG00445
OG00590
OG00690
Title
Denominators
Categories
Title
Measurements
OG00010
OG00119
OG0025
OG00313
OG0046
OG00517
OG00614
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.
Posted
Count of Participants
Participants
During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG003
Title
Denominators
Categories
Any Pain, Dose 1
ParticipantsOG00090
ParticipantsOG00190
ParticipantsOG00245
ParticipantsOG003
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom 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 for whom data are available and who had their symptom sheets filled in.
Posted
Count of Participants
Participants
During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG003
Title
Denominators
Categories
Any Drowsiness, Dose 1
ParticipantsOG00090
ParticipantsOG00190
ParticipantsOG00245
ParticipantsOG003
Secondary
Number of Subjects With Any 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.
The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.
Posted
Count of Participants
Participants
During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00090
OG00190
OG00245
OG003
Title
Denominators
Categories
Title
Measurements
OG00078
OG00182
OG00240
OG003
Secondary
Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/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
EL.U/mL
At Day 0, at Month 2, at Month 7 and at Month 10
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00087
OG00186
OG00244
OG003
Title
Denominators
Categories
Day 0
ParticipantsOG00087
ParticipantsOG00186
ParticipantsOG00244
ParticipantsOG003
Secondary
Titers for Anti-Hepatitis B (Anti-HBs)
Titers are presented as geometric mean titers (GMTs) 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
At Day 0 and at Month 2
ID
Title
Description
OG000
SB257049 F2 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
OG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
Units
Counts
Participants
OG00087
OG00186
OG00244
OG003
Title
Denominators
Categories
Day 0
ParticipantsOG00087
ParticipantsOG00186
ParticipantsOG00244
ParticipantsOG003
0
90
18
90
85
90
EG001
SB257049 F1 0-1 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle.
1
90
23
90
87
90
EG002
SB257049 F2 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
0
45
11
45
44
45
EG003
SB257049 F1 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
0
90
22
90
89
90
EG004
Rabipur 0-1-2 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle.
1
45
7
45
43
45
EG005
SB257049 F2 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
0
90
24
90
89
90
EG006
SB257049 F1 0-1-7 M Group
Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle.
2
90
17
90
89
90
EG0005 events5 affected90 at risk
EG0019 events9 affected90 at risk
EG0021 events1 affected45 at risk
EG0034 events4 affected90 at risk
EG0043 events3 affected45 at risk
EG0059 events9 affected90 at risk
EG0065 events5 affected90 at risk
Cerebral palsy
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Glucose-6-phosphate dehydrogenase deficiency
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0052 events2 affected90 at risk
EG0060 events0 affected90 at risk
Sickle cell anaemia
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Sickle cell anaemia with crisis
Congenital, familial and genetic disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Enteritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Inguinal hernia
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Intussusception
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0060 events0 affected90 at risk
Mouth haemorrhage
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Bronchiolitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected45 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected45 at risk
EG0052 events2 affected90 at risk
EG0062 events2 affected90 at risk
Bronchopneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0013 events3 affected90 at risk
EG0023 events3 affected45 at risk
EG0032 events2 affected90 at risk
EG0041 events1 affected45 at risk
EG0055 events5 affected90 at risk
EG0064 events4 affected90 at risk
Cellulitis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Cerebral malaria
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Dysentery
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Escherichia sepsis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Gastroenteritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0003 events3 affected90 at risk
EG0013 events3 affected90 at risk
EG0022 events2 affected45 at risk
EG00310 events10 affected90 at risk
EG0040 events0 affected45 at risk
EG0053 events3 affected90 at risk
EG0065 events5 affected90 at risk
Gastroenteritis bacterial
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Impetigo
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Malaria
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Otitis media
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Plasmodium falciparum infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0009 events9 affected90 at risk
EG0017 events6 affected90 at risk
EG0025 events5 affected45 at risk
EG0037 events6 affected90 at risk
EG0045 events4 affected45 at risk
EG0056 events6 affected90 at risk
EG0066 events6 affected90 at risk
Pneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Pneumonia primary atypical
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Rash pustular
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Salmonella sepsis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Sepsis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0003 events3 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0034 events3 affected90 at risk
EG0042 events2 affected45 at risk
EG0054 events4 affected90 at risk
EG0061 events1 affected90 at risk
Skin infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Staphylococcal skin infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Subcutaneous abscess
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Typhoid fever
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0012 events2 affected90 at risk
EG0021 events1 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0053 events3 affected90 at risk
EG0061 events1 affected90 at risk
Urinary tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0060 events0 affected90 at risk
Burns second degree
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Drug toxicity
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Pneumonitis chemical
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Thermal burn
Injury, poisoning and procedural complications
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Dehydration
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected90 at risk
EG0013 events3 affected90 at risk
EG0021 events1 affected45 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0062 events2 affected90 at risk
Hypoglycaemia
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Malnutrition
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected45 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected45 at risk
EG0052 events2 affected90 at risk
EG0060 events0 affected90 at risk
Convulsion
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Epilepsy
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Febrile convulsion
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0007 events6 affected90 at risk
EG0016 events4 affected90 at risk
EG0023 events3 affected45 at risk
EG0032 events2 affected90 at risk
EG0042 events2 affected45 at risk
EG0051 events1 affected90 at risk
EG0064 events3 affected90 at risk
Hemiparesis
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Bladder diverticulum
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0061 events1 affected90 at risk
Renal failure acute
Renal and urinary disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Foreign body aspiration
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Respiratory distress
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Dermatitis allergic
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
Stevens-johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0041 events1 affected45 at risk
EG0050 events0 affected90 at risk
EG0060 events0 affected90 at risk
EG0002 events2 affected90 at risk
EG0015 events5 affected90 at risk
EG0023 events3 affected45 at risk
EG0038 events8 affected90 at risk
EG0047 events6 affected45 at risk
EG0053 events3 affected90 at risk
EG0065 events5 affected90 at risk
Bronchopneumonia
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0004 events4 affected90 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected45 at risk
EG0036 events6 affected90 at risk
EG00410 events10 affected45 at risk
EG0053 events3 affected90 at risk
EG0067 events7 affected90 at risk
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected45 at risk
EG0034 events4 affected90 at risk
EG0043 events3 affected45 at risk
EG0050 events0 affected90 at risk
EG0062 events1 affected90 at risk
Decreased appetite
Metabolism and nutrition disorders
MedDRA 11.0
Systematic Assessment
EG00027 events26 affected90 at risk
EG00128 events25 affected90 at risk
EG00225 events18 affected45 at risk
EG00343 events34 affected90 at risk
EG00414 events13 affected45 at risk
EG00555 events42 affected90 at risk
EG00652 events39 affected90 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0004 events4 affected90 at risk
EG0017 events6 affected90 at risk
EG0020 events0 affected45 at risk
EG0036 events5 affected90 at risk
EG0045 events5 affected45 at risk
EG00510 events8 affected90 at risk
EG00610 events9 affected90 at risk
Dysentery
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0003 events3 affected90 at risk
EG0016 events6 affected90 at risk
EG0022 events2 affected45 at risk
EG0033 events3 affected90 at risk
EG0041 events1 affected45 at risk
EG0053 events3 affected90 at risk
EG0061 events1 affected90 at risk
Eating disorder
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG0000 events0 affected90 at risk
EG0012 events2 affected90 at risk
EG0024 events4 affected45 at risk
EG0033 events3 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0062 events2 affected90 at risk
Enteritis
Gastrointestinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected90 at risk
EG0011 events1 affected90 at risk
EG0023 events3 affected45 at risk
EG0031 events1 affected90 at risk
EG0040 events0 affected45 at risk
EG0055 events5 affected90 at risk
EG0061 events1 affected90 at risk
Gastroenteritis
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG00019 events19 affected90 at risk
EG00127 events27 affected90 at risk
EG00214 events13 affected45 at risk
EG00331 events28 affected90 at risk
EG0049 events9 affected45 at risk
EG00533 events28 affected90 at risk
EG00627 events23 affected90 at risk
Impetigo
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0007 events7 affected90 at risk
EG0012 events2 affected90 at risk
EG0020 events0 affected45 at risk
EG00312 events11 affected90 at risk
EG0045 events5 affected45 at risk
EG00516 events15 affected90 at risk
EG00613 events12 affected90 at risk
Irritability
Psychiatric disorders
MedDRA 11.0
Systematic Assessment
EG00059 events49 affected90 at risk
EG00137 events32 affected90 at risk
EG00235 events23 affected45 at risk
EG00371 events47 affected90 at risk
EG00417 events16 affected45 at risk
EG00599 events63 affected90 at risk
EG00670 events45 affected90 at risk
Lower respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0005 events5 affected90 at risk
EG0013 events3 affected90 at risk
EG0020 events0 affected45 at risk
EG0033 events3 affected90 at risk
EG0042 events2 affected45 at risk
EG0051 events1 affected90 at risk
EG0066 events6 affected90 at risk
Malaria
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG00029 events24 affected90 at risk
EG00126 events23 affected90 at risk
EG00216 events15 affected45 at risk
EG00325 events24 affected90 at risk
EG00417 events17 affected45 at risk
EG00532 events30 affected90 at risk
EG00631 events27 affected90 at risk
Otitis media
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected90 at risk
EG0012 events2 affected90 at risk
EG0025 events4 affected45 at risk
EG0036 events5 affected90 at risk
EG0041 events1 affected45 at risk
EG0059 events8 affected90 at risk
EG00610 events10 affected90 at risk
Pain
General disorders
MedDRA 11.0
Systematic Assessment
EG00098 events68 affected90 at risk
EG00152 events41 affected90 at risk
EG00258 events32 affected45 at risk
EG00380 events50 affected90 at risk
EG00427 events21 affected45 at risk
EG005142 events78 affected90 at risk
EG006116 events67 affected90 at risk
Plasmodium falciparum infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG00012 events12 affected90 at risk
EG0018 events8 affected90 at risk
EG0022 events2 affected45 at risk
EG00311 events11 affected90 at risk
EG00415 events13 affected45 at risk
EG00516 events14 affected90 at risk
EG00617 events15 affected90 at risk
Pyrexia
General disorders
MedDRA 11.0
Systematic Assessment
EG00072 events52 affected90 at risk
EG00163 events47 affected90 at risk
EG00252 events33 affected45 at risk
EG00398 events63 affected90 at risk
EG00415 events14 affected45 at risk
EG005128 events69 affected90 at risk
EG006123 events73 affected90 at risk
Respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected90 at risk
EG0014 events4 affected90 at risk
EG0023 events3 affected45 at risk
EG0038 events8 affected90 at risk
EG0042 events2 affected45 at risk
EG0059 events7 affected90 at risk
EG0060 events0 affected90 at risk
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 11.0
Systematic Assessment
EG0002 events2 affected90 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected45 at risk
EG0030 events0 affected90 at risk
EG0043 events3 affected45 at risk
EG0051 events1 affected90 at risk
EG0061 events1 affected90 at risk
Skin infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG0001 events1 affected90 at risk
EG0016 events6 affected90 at risk
EG0023 events2 affected45 at risk
EG0032 events2 affected90 at risk
EG0040 events0 affected45 at risk
EG0051 events1 affected90 at risk
EG0062 events2 affected90 at risk
Somnolence
Nervous system disorders
MedDRA 11.0
Systematic Assessment
EG00026 events23 affected90 at risk
EG00126 events23 affected90 at risk
EG00222 events17 affected45 at risk
EG00335 events23 affected90 at risk
EG0047 events6 affected45 at risk
EG00546 events35 affected90 at risk
EG00639 events33 affected90 at risk
Swelling
General disorders
MedDRA 11.0
Systematic Assessment
EG00044 events35 affected90 at risk
EG00121 events17 affected90 at risk
EG00247 events31 affected45 at risk
EG00334 events28 affected90 at risk
EG0043 events3 affected45 at risk
EG00549 events34 affected90 at risk
EG00637 events25 affected90 at risk
Upper respiratory tract infection
Infections and infestations
MedDRA 11.0
Systematic Assessment
EG00046 events39 affected90 at risk
EG00160 events49 affected90 at risk
EG00236 events28 affected45 at risk
EG00364 events45 affected90 at risk
EG00438 events25 affected45 at risk
EG00562 events49 affected90 at risk
EG00663 events49 affected90 at risk
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.