Malaria, Malaria Vaccines
Conditions
Keywords
Children, Infants, SB257049, Malaria, Immunogenicity, Surveillance, Efficacy, Safety, Africa, Plasmodium falciparum
Brief summary
The purpose of this study is to assess the immunogenicity, safety, and reactogenicity of the SB257049 candidate malaria vaccine when co-administered with Vitamin A, measles, rubella and yellow fever vaccines to children aged 6 months at the first vaccination.
Interventions
DIETARY_SUPPLEMENTVitamin A
Oral administration of Vitamin A (1 dose)
BIOLOGICALCandidate Plasmodium falciparum malaria vaccine
Intramuscular administration of SB257049 vaccine (4 doses)
BIOLOGICALMR-Vac
Subcutaneous injection of a combined measles and rubella vaccine (1 dose)
BIOLOGICALStamaril
Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 6 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects' parent(s)/Legally Acceptable Representative(s) (LAR\[s\]) who, in the opinion of the investigator, could and complied with the requirements of the protocol. * A male or female 6 months of age (from the day the child becomes 6 months of age until the day before the child achieved 7 months of age) at the time of the first vaccination. * Signed or thumb-printed informed consent obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) were illiterate, the consent form was countersigned by an independent witness. * Healthy subjects as established by medical history and clinical examination before entering into the study. * Previously received three documented doses of diphtheria, tetanus, and whole-cell pertussis, hepatitis B vaccine (DTPwHepB), and a 3-dose course of oral polio vaccine and, if locally recommended, pneumococcal and rotavirus vaccines.
Exclusion criteria
* Child in care * Use of a drug or vaccine that is not approved for that indication other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * Any medical condition that in the judgment of the investigator would make intramuscular injection unsafe. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. For corticosteroids, this meant prednisone≥ 0.5 mg/kg/day, or equivalent. Inhaled and topical steroids were allowed. * Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting seven days before the first dose of SB257049 measles, rubella and YF vaccines and ending 42 days after the last dose of vaccines given at 9 months of age (Visit 4), with the exception of oral polio vaccine which could be given for unforeseen public health threat. * 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 vaccine/product. * Previous vaccination against measles, YF or rubella. * Previous administration of Vitamin A. * Moderate or severe malnutrition at screening defined as weight for age Z-score \< -2. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * Family history of congenital or hereditary immunodeficiency. * History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). See also Section 1.3. * Major congenital defects or serious chronic illness. * History of any neurological disorders or seizures. * Acute disease and/or fever at the time of enrolment. Fever was defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic route, or ≥ 38.0°C /100.4°F on rectal route. The preferred route for recording temperature in this study was axillary. Subjects with a minor illness without fever might have been enrolled at the discretion of the investigator. * Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period. * Same sex twin. * Maternal death. * Previous participation in any other malaria study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis) | At one month post Dose 3 of SB257049 (Month 4) | Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. |
| Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis) | At one month post Dose 3 of SB257049 (Month 4) | Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 | At Day 0 and one month post Dose 3 of SB257049 (Month 4) | Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group. |
| Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 | At Day 0 and one month post-Dose 3 of SB257049 (Month 4) | Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter \[mIU/mL\]). Seroprotection was assessed in the Coad Group and the RTS,S Group. |
| Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine | At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4) | Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group. |
| Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4) | Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group. |
| Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | At pre-vaccination (Month 3) and one month post-vaccination with the combined measles and rubella vaccine (Month 4) | A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group. |
| Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine | At one month post-vaccination with combined measles and rubella vaccine (Month 4) | Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (\<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group. |
| Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4) | Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group. |
| Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4) | A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group. |
| Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine | At one month post-vaccination with the YF vaccine (Month 4) | Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group. |
| Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine | At one month post-vaccination with the YF vaccine (Month 4) | Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site. |
| Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0) | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A (Day 0) | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) at injection site. |
| Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5) | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination. |
| Number of Subjects With Solicited General Symptoms for the Control Group, After Visit at 7.5 Months of Age | After visit at Month 1.5 | Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit. |
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3) | Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site. |
| Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 | At Day 0 and one month post Dose 3 of SB257049 (Month 4) | Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. |
| Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Within 30-day (Days 0-29) period after dose 1 of SB257049 and Vitamin A- Coad and RTS,S Groups, and 30-day period after Vitamin A administration - Control Group | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age | Within 30-day (Day of vaccination and 29 subsequent days) period after dose 2 of SB257049 administered at Month 1.5 - Coad and RTS,S Groups | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age | During the 30-day period (Day of the visit and 29 subsequent days) after the visit at Month 1.5 | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Within 42-day (vaccination day and 41 subsequent days) period after dose 3 of SB257049 in Coad (+MeRu+YF vaccines) and RTS,S groups, and 42-day period after MeRU+YF vaccination in Control group, administered at Month 3 | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | During 30-Days period (Day of vaccination and 29 subsequent days) following each administration at Day 0, Month1.5 and Month 3 for Coad and RTS,S groups and at Day 0 and Month 3 in the Control Group. | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5 | From Day 0 up to Month 4.5 | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5 | From Day 0 up to Month 4.5 | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology. |
| Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5 | From Day 0 up to Month 4.5 | Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age | Within 30 days post-vaccination for vaccine doses administered at Day 0, Month 1.5 or 42 days post-vaccination (doses given at Month 3 [Coad & Control Groups] or Month 4.5 [RTS,S Group]) vaccination period from Day 0 until Month 4.5 | Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups) | Within 7 days after vaccines administered at Day 0 and Month 1.5 for the Coad and RTS,S groups and 14 days after vaccines administered at Month 3 for all groups | Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age | During the 30-day period (Day of vaccination and 29 subsequent days) after booster dose administered at Month 21 | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age | During the 30-Day Period (Day of vaccination and 29 subsequent days) after primary doses of study vaccine administered at Month 4.5, Month 5.5, Month 6.5 (across primary doses), and after booster dose administered at Month 24 | An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. |
| Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End | During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group) | SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
| Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End | During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group) | pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology. |
| Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End | During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group) | Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration. |
| Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group | Within 30 days post-vaccination (doses given at Day 0, Month 1.5, Month 21) & 42 days post-vaccination (dose given at Month 3 [Coad Group] or Month 4.5 [RTS,S Group]) | Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for Coad and RTS,S Groups. |
| Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group | Within 30 days post-vaccination (doses given at Month 4.5, Month 5.5, Month 6.5, Month 24) & 42 days post-vaccination (dose given at Month 3) | Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for the Control Group. |
| Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3) | Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination. |
| Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 | At Day 0 and one month post Dose 3 of SB257049 (Month 4) | A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter \[EU/mL\]). Seropositivity was assessed in the Coad Group and the RTS,S Group. |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Coad Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age). | 231 |
| RTS,S Group Children randomized received Vitamin A at 6 months of age, SB257049 vaccine at 6, 7.5 and 9 months of age, and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 10.5 months of age. Subjects received a booster dose of SB257049 vaccine at 18 months post Dose 3 (i.e. at 27 months of age). | 236 |
| Control Group Children randomized received Vitamin A at 6 months of age and Yellow Fever (YF) vaccine and a combined measles and rubella vaccine at 9 months of age. These children received SB257049 vaccine at 10.5, 11.5 and 12.5 months of age plus a booster dose 17.5 months post Dose 3 (i.e. at 30 months of age). | 232 |
| Total | 699 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 2 |
| Overall Study | CONSENT WITHDRAWAL NOT DUE TO ADV. EVENT | 7 | 2 | 4 |
| Overall Study | Lost to Follow-up | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Coad Group | RTS,S Group | Control Group | Total |
|---|---|---|---|---|
| Age, Continuous | 6.3 Months STANDARD_DEVIATION 0.3 | 6.3 Months STANDARD_DEVIATION 0.3 | 6.3 Months STANDARD_DEVIATION 0.3 | 6.3 Months STANDARD_DEVIATION 0.3 |
| Race/Ethnicity, Customized BLACK OR AFRICAN AMERICAN | 231 Participants | 236 Participants | 232 Participants | 699 Participants |
| Sex: Female, Male Female | 116 Participants | 119 Participants | 113 Participants | 348 Participants |
| Sex: Female, Male Male | 115 Participants | 117 Participants | 119 Participants | 351 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 2 / 231 | 0 / 236 | 3 / 232 |
| other Total, other adverse events | 219 / 231 | 221 / 236 | 207 / 232 |
| serious Total, serious adverse events | 61 / 231 | 62 / 236 | 66 / 232 |
Outcome results
Primary
Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis)
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: Enzyme Linked Immunosorbent Assay (ELISA) units per milliliter (EU/mL). The 95% confidence intervals were calculated using the Analysis of Variance (ANOVA) model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
Time frame: At one month post Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity defined for the primary analysis (Month 4.5), which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling outside protocol windows were eliminated.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coad Group | Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis) | 452.87 EU/mL |
| RTS,S Group | Anti-Circumsporozoite (Anti-CS) Antibody Concentrations, One Month Post Dose 3 of SB257049 (Primary Analysis) | 422.49 EU/mL |
Comparison: Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.95% CI: [0.81, 1.07]ANOVA
Primary
Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis)
Concentrations were expressed as GMCs with the following unit of measure: EU/mL. The 95% confidence intervals were calculated using the ANOVA model. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group. The analysis was re-evaluated and performed on the Per-Protocol set for immunogenicity defined at study end.
Time frame: At one month post Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity, defined at study end, which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated. One subject that was eliminated at the primary analysis performed at Month 4.5 was included in this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coad Group | Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis) | 454.51 EU/mL |
| RTS,S Group | Anti-CS Antibody Concentrations, One Month Post Dose 3 of SB257049 (Study End Analysis) | 422.49 EU/mL |
Comparison: Adjusted GMC ratios for anti-CS antibody: To demonstrate the non-inferiority of the antibody response to the CS antigen when SB257049 is co-administered with YF vaccine and a combined measles and rubella vaccine versus SB257049 administered alone.95% CI: [0.81, 1.07]ANOVA
Secondary
Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049
Concentrations were expressed as Geometric Mean Concentrations (GMCs) with the following unit of measure: ELISA units per milliliter (EU/mL). The 95% CI for the GMC was obtained by exponential transformation (base 10) of the 95% CI for the mean of the log transformed concentrations. The antibody response of anti-CS was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity, defined at study end, which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coad Group | Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Day 0 | 0.96 EU/mL |
| Coad Group | Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Month 4 | 454.51 EU/mL |
| RTS,S Group | Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Day 0 | 0.96 EU/mL |
| RTS,S Group | Anti-CS Antibody Concentrations, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Month 4 | 422.49 EU/mL |
Secondary
Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049
Concentrations were expressed as GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-HB was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coad Group | Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HBs - Day 0 | 397.36 mIU/mL |
| Coad Group | Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HBs - Month 4 | 42162.55 mIU/mL |
| RTS,S Group | Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HBs - Day 0 | 427.65 mIU/mL |
| RTS,S Group | Anti-hepatitis B (Anti-HBs) Antibody Concentrations, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HBs - Month 4 | 43261.19 mIU/mL |
Secondary
Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Concentrations were expressed in GMCs with the following unit of measure: milli-international unit per milliliter (mIU/mL). The antibody response of anti-Me was assessed in the Coad Group and the Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coad Group | Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 3 | 75.00 mIU/mL |
| Coad Group | Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 4 | 565.81 mIU/mL |
| RTS,S Group | Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 3 | 75.00 mIU/mL |
| RTS,S Group | Anti-Me Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 4 | 572.09 mIU/mL |
Secondary
Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Concentrations were expressed as GMCs with the following unit of measure: International unit per milliliter (IU/mL). The antibody response of anti-Ru was assessed in the Coad Group and Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| Coad Group | Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 3 | 2.08 IU/mL |
| Coad Group | Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 4 | 39.36 IU/mL |
| RTS,S Group | Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 3 | 2.09 IU/mL |
| RTS,S Group | Anti-Ru Antibody Concentrations, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 4 | 42.45 IU/mL |
Secondary
Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine
Titers were expressed as Geometric Mean Titres (GMTs). The antibody response of anti-YF was assessed in the Coad Group and Control Group.
Time frame: At one month post-vaccination with the YF vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Coad Group | Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine | 324.31 Titers |
| RTS,S Group | Anti-YF Antibody Titers One Month Post-vaccination With the YF Vaccine | 346.60 Titers |
Secondary
Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine
Seroconversion was defined as number of subjects with an anti-Measles antibodies pre-vaccination concentration below 150 mIU/mL and a post-vaccination concentration ≥150 mIU/mL. Seroconversion was assessed in the Coad group and the Control group.
Time frame: At one month post-vaccination with the combined measles and rubella (MeRu) vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine | 197 Participants |
| RTS,S Group | Number of Seroconverted Subjects for Anti-Measles (Anti-Me) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella (MeRu) Vaccine | 212 Participants |
Comparison: Difference in seroconversion rates against measles antibodies: To demonstrate the non-inferiority of the antibody response to the measles vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.95% CI: [-1.29, 5.89]Miettinen and Nurminen method
Secondary
Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine
Seroconversion was defined as number of subjects with an anti-Ru pre-vaccination concentration less than (\<) 4 IU/mL and a post-vaccination concentration ≥ 4 IU/mL. Seroconversion was assessed in the Coad group and Control group.
Time frame: At one month post-vaccination with combined measles and rubella vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine | 199 Participants |
| RTS,S Group | Number of Seroconverted Subjects for Anti-Rubella (Anti-Ru) Antibodies, One Month Post-vaccination With the Combined Measles and Rubella Vaccine | 212 Participants |
Comparison: Difference in seroconversion rates against Rubella antibodies: To demonstrate the non-inferiority of the antibody response to the rubella vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered.~with SB257049 versus administration without SB257049.95% CI: [-1.29, 2.78]Miettinen and Nurminen method
Secondary
Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-CS ≥ 1.9 ELISA unit per milliliter \[EU/mL\]). Seropositivity was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity, defined at study end, which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Day 0 | 1 Participants |
| Coad Group | Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Month 4 | 207 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Day 0 | 2 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-CS Antibodies, Pre-vaccination and One Month Post Dose 3 of SB257049 | Anti-CS - Month 4 | 213 Participants |
Secondary
Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
A subject seropositive for anti-CS antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Me ≥ 150 mIU/mL). Seropositivity was assessed in the Coad Group and the Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with the combined measles and rubella vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 3 | 0 Participants |
| Coad Group | Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 4 | 200 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 3 | 0 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-Me Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Me - Month 4 | 213 Participants |
Secondary
Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine
A subject seropositive for anti-Ru antibody was a subject whose antibody concentration was greater than or equal (≥) to the cut-off value (anti-Ru ≥ 4 IU/mL). Seropositivity was assessed in the Coad Group and Control Group.
Time frame: At pre-vaccination (Month 3) and one month post-vaccination with combined measles and rubella vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 3 | 5 Participants |
| Coad Group | Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 4 | 207 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 3 | 4 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-Ru Antibodies, Pre-vaccination and One Month Post-vaccination With the Combined Measles and Rubella Vaccine | Anti-Ru - Month 4 | 217 Participants |
Secondary
Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine
Seropositivity was defined as number of subjects with anti-YF titers greater than or equal to (≥) 10 End point Dilution 50 (ED50). Seropositivity was assessed in the Coad group and Control group.
Time frame: At one month post-vaccination with the YF vaccine (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine | 203 Participants |
| RTS,S Group | Number of Seropositive Subjects for Anti-Yellow Fever (Anti-YF) Antibodies, at One Month Post-vaccination With the YF Vaccine | 214 Participants |
Comparison: Difference in seropositivity rates against Yellow Fever antibodies: To demonstrate the non-inferiority of the antibody response to the YF vaccine antigen when YF vaccine and a combined measles and rubella vaccine are coadministered with SB257049 versus administration without SB257049.95% CI: [-2.3, 3.65]Miettinen and Nurminen method
Secondary
Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049
Seroprotection rate for anti-HBs antibody was defined as the percentage of subjects with antibody concentrations greater than or equal to an established cut-off value (anti-HBs ≥ 10 milli-international unit per milliliter \[mIU/mL\]). Seroprotection was assessed in the Coad Group and the RTS,S Group.
Time frame: At Day 0 and one month post-Dose 3 of SB257049 (Month 4)
Population: Analysis was performed on the Per-Protocol set for immunogenicity which included all evaluable subjects meeting all eligibility criteria, complying with protocol defined procedures, with no elimination criteria during the study, and who had available data concerning the outcome measure. Subjects with incomplete vaccination course or blood sampling performed outside protocol defined windows were eliminated.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HB - Day 0 | 196 Participants |
| Coad Group | Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HB - Month 4 | 205 Participants |
| RTS,S Group | Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HB - Day 0 | 201 Participants |
| RTS,S Group | Number of Seroprotected Subjects for Anti-HB Antibodies, Pre-vaccination and One Month Post-Dose 3 of SB257049 | Anti-HB - Month 4 | 210 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
Time frame: During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)
Population: Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu+YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Any | 10 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Any | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Any | 3 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Any | 10 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Any | 3 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Any | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Any | 2 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Redness - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Pain - Any | 1 Participants |
| Control Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Swelling - Any | 1 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) at injection site.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)
Population: Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Redness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Pain - Any | 25 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Swelling - Any | 8 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Redness - Any | 7 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Swelling - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Pain - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Swelling - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Pain - Grade 3 | 1 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Redness - Any | 13 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Redness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Swelling - Any | 6 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Pain - Any | 16 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = subject crying when limb was moved /spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimetres (mm) at injection site.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)
Population: Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Pain - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Redness - Grade 3 | 1 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Pain - Any | 3 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Swelling - Any | 4 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Redness - Any | 4 Participants |
| Coad Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Swelling - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Swelling - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Pain - Any | 12 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Pain - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Redness - Any | 2 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Redness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms for Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Swelling - Any | 6 Participants |
Secondary
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 14-day follow-up period (day of administration and 13 subsequent days) after administration of SB257049 dose 3 in Coad (and MeRu+YF) and RTS,S Groups and after MeRu+YF vaccines in Control Group (Month 3)
Population: Analysis was performed on the Exposed set which included all subjects with SB257049 dose 3 for Coad (and MeRu + YF vaccines) and RTS,S Groups, and MeRU+YF vaccines for Control Group.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Any | 11 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Related | 4 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Related | 2 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Any | 8 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Any | 7 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 related | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Related | 26 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Related | 4 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 | 3 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Any | 54 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Related | 4 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 related | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Any | 6 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Related | 5 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Any | 6 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Related | 2 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Any | 8 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Any | 50 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 | 2 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Related | 23 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Related | 8 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Any | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Grade 3 related | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Any | 2 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Grade 3 | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Irritability/Fussiness - Any | 1 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Fever - Any | 17 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| Control Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for All Groups, After Dose of Study Vaccines Administered at 9 Months of Age | Drowsiness - Related | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A and SB257049 dose 1 (Day 0)
Population: Analysis was performed on the Exposed set which included all subjects with the first dose of SB257049 and Vitamin A administered (Coad and RTS,S Groups).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Any | 14 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Grade 3 | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Related | 2 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Any | 4 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Grade 3 | 3 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Related | 10 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Any | 5 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Grade 3 related | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Any | 32 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Any | 4 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Any | 22 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Grade 3 | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Related | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Any | 7 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Any | 30 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Grade 3 | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Fever - Related | 8 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Administration of Vitamin A and Study Vaccines at 6 Months of Age | Drowsiness - Grade 3 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 Fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of SB257049 dose 2 (Month 1.5)
Population: Analysis was performed on the Exposed set which included all subjects with the second dose of SB257049 administered (Coad and RTS,S Groups).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Related | 4 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Any | 6 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Related | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Any | 11 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Any | 6 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Related | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Any | 47 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Grade 3 | 3 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Related | 11 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Grade 3 related | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Grade 3 | 3 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Any | 5 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Related | 2 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Grade 3 related | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Any | 13 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Any | 47 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Grade 3 | 1 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Related | 2 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Fever - Related | 9 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Any | 11 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| RTS,S Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Coad Group and RTS,S Group After Dose of Study Vaccines Administered at 7.5 Months of Age | Loss of appetite - Grade 3 | 0 Participants |
Secondary
Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite, measles/rubella-like rash and fever. Any = occurrence of the symptom regardless of intensity grade. Any Fever = temperature greater than or equal to (≥) 37.5° C (axillary route). Grade 3 drowsiness= symptom that prevented normal activity; Grade 3 Irritability/Fussiness = Crying that couldn't be comforted/prevented normal activity; Grade 3 Loss of appetite = not eating at all; Grade 3 Measles /rubella rash = \>150 lesions; Grade 3 fever= temperature grater than (\>) 39°C; Related = symptom assessed by the investigator as causally related to the vaccination.
Time frame: During a 7-day follow-up period (day of administration and 6 subsequent days) after administration of Vitamin A (Day 0)
Population: Analysis was performed on the Exposed set which included all subjects with Vitamin A administered (Control group). In the Control Group, only solicited general symptoms were collected.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Drowsiness - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Drowsiness - Any | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Drowsiness - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Drowsiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Irritability/Fussiness - Any | 6 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Irritability/Fussiness - Grade 3 | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Irritability/Fussiness - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Irritability/Fussiness - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Loss of appetite - Any | 9 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Loss of appetite- Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Loss of appetite- Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Loss of appetite- Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Measles/Rubella-like rash - Any | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Measles/Rubella-like rash - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Measles/Rubella-like rash - Related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Measles/Rubella-like rash - Grade 3 related | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Fever - Any | 11 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Fever - Grade 3 | 0 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Fever - Related | 1 Participants |
| Coad Group | Number of Subjects With Any, Grade 3, Related, Grade 3 and Related Solicited General Symptoms for the Control Group After Administration of Vitamin A at 6 Months of Age | Fever - Grade 3 related | 0 Participants |
Secondary
Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 up to Month 4.5
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccines or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5 | 14 Participants |
| RTS,S Group | Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5 | 12 Participants |
| Control Group | Number of Subjects With Any SAEs for All Study Groups, From Day 0 Until Month 4.5 | 21 Participants |
Secondary
Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups)
Generalized convulsive seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: Within 7 days after vaccines administered at Day 0 and Month 1.5 for the Coad and RTS,S groups and 14 days after vaccines administered at Month 3 for all groups
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups) | 0 Participants |
| RTS,S Group | Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups) | 0 Participants |
| Control Group | Number of Subjects With Generalized Convulsive Seizure for All Study Groups, After Vaccines Administered at Day 0 and Month 1.5 (Coad and RTS,S Groups) and After Vaccines Administered at Month 3 (All Groups) | 0 Participants |
Secondary
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration.
Time frame: From Day 0 up to Month 4.5
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
| RTS,S Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
| Control Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
Secondary
Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End
Meningitis is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End | 0 Participants |
| RTS,S Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End | 1 Participants |
| Control Group | Number of Subjects With Meningitis for All Study Groups From Day 0 Until Study End | 1 Participants |
Secondary
Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End | 0 Participants |
| RTS,S Group | Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End | 1 Participants |
| Control Group | Number of Subjects With pIMDs for All Study Groups From Day 0 Until Study End | 0 Participants |
Secondary
Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5
pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune etiology.
Time frame: From Day 0 up to Month 4.5
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
| RTS,S Group | Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
| Control Group | Number of Subjects With Potential Immune-Mediated Disease (pIMDs) for All Study Groups From Day 0 Until Month 4.5 | 0 Participants |
Secondary
Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During the entire study period (From Day 0 until Month 33 for Coad and RTS,S Groups and Month 36 for the Control Group)
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End | 61 Participants |
| RTS,S Group | Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End | 62 Participants |
| Control Group | Number of Subjects With SAEs for All Study Groups From Day 0 Until Study End | 66 Participants |
Secondary
Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It is assessed by the investigator as specific to the treatment administration.
Time frame: Within 30 days post-vaccination for vaccine doses administered at Day 0, Month 1.5 or 42 days post-vaccination (doses given at Month 3 [Coad & Control Groups] or Month 4.5 [RTS,S Group]) vaccination period from Day 0 until Month 4.5
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age | 0 Participants |
| RTS,S Group | Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age | 0 Participants |
| Control Group | Number of Subjects With Seizures for All Groups, Post-vaccination for Vaccines Administered at 6, 7.5 or 9 Months of Age | 0 Participants |
Secondary
Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for the Control Group.
Time frame: Within 30 days post-vaccination (doses given at Month 4.5, Month 5.5, Month 6.5, Month 24) & 42 days post-vaccination (dose given at Month 3)
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Seizures for Vaccines Doses Administered at 10.5, 11.5, 12.5, 30 and 9 Months of Age for Control Group | 1 Participants |
Secondary
Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group
Seizure is an adverse event of specific interest (AESI). An AESI is defined as an AE including autoimmune diseases and other mediated inflammatory disorders. It was assessed by the investigator as specific to the treatment administration. Results are presented across all doses for Coad and RTS,S Groups.
Time frame: Within 30 days post-vaccination (doses given at Day 0, Month 1.5, Month 21) & 42 days post-vaccination (dose given at Month 3 [Coad Group] or Month 4.5 [RTS,S Group])
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group | 0 Participants |
| RTS,S Group | Number of Subjects With Seizures for Vaccines Doses Administered at 6, 7.5, 27 Months of Age for Coad and RTS,S Groups; and at 9 Months of Age for Coad Group or 10.5 Months of Age for RTS,S Group | 0 Participants |
Secondary
Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: During 30-Days period (Day of vaccination and 29 subsequent days) following each administration at Day 0, Month1.5 and Month 3 for Coad and RTS,S groups and at Day 0 and Month 3 in the Control Group.
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of the study vaccine or Vitamin A administered.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Related SAEs | 0 Participants |
| Coad Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Fatal SAEs | 1 Participants |
| Coad Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Any SAEs | 13 Participants |
| RTS,S Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Related SAEs | 0 Participants |
| RTS,S Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Any SAEs | 8 Participants |
| RTS,S Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Fatal SAEs | 0 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Fatal SAEs | 1 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Any SAEs | 16 Participants |
| Control Group | Number of Subjects With Serious Adverse Events (SAEs): All, Fatal and Related, for All Study Groups, Following Each Administration at Day 0, Month1.5 and Month 3 | Related SAEs | 0 Participants |
Secondary
Number of Subjects With Solicited General Symptoms for the Control Group, After Visit at 7.5 Months of Age
Solicited symptoms were not analyzed for the Control Group after visit at Month 1.5 because no vaccination was administered at that visit.
Time frame: After visit at Month 1.5
Population: Analysis was not performed. Solicited symptoms were not collected for the Control group after visit at Month 1.5 because no vaccination was administered.
Secondary
Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 30-day (Days 0-29) period after dose 1 of SB257049 and Vitamin A- Coad and RTS,S Groups, and 30-day period after Vitamin A administration - Control Group
Population: Analysis was performed on the Exposed set which included all subjects with first dose of the study vaccine + Vitamin A (Coad and RTS,S Groups) or Vitamin A (Control Group).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age | 116 Participants |
| RTS,S Group | Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age | 119 Participants |
| Control Group | Number of Subjects With Unsolicited Adverse Events (AEs) for All Groups, After Administration of Vitamin A and Study Vaccines at 6 Months of Age | 111 Participants |
Secondary
Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 42-day (vaccination day and 41 subsequent days) period after dose 3 of SB257049 in Coad (+MeRu+YF vaccines) and RTS,S groups, and 42-day period after MeRU+YF vaccination in Control group, administered at Month 3
Population: Analysis was performed on the Exposed set which included all subjects with the third dose of the study vaccine for Coad (+MeRu+YF vacines) and RTS,S Groups, or MeRU + YF vaccine for the Control Group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age | 120 Participants |
| RTS,S Group | Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age | 121 Participants |
| Control Group | Number of Subjects With Unsolicited AEs for All Study Groups, After Dose of Study Vaccines Administered at 9 Months of Age | 125 Participants |
Secondary
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: Within 30-day (Day of vaccination and 29 subsequent days) period after dose 2 of SB257049 administered at Month 1.5 - Coad and RTS,S Groups
Population: Analysis was performed on the Exposed set which included all subjects with the second dose of the study vaccine administered (Coad and RTS,S Groups).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age | 107 Participants |
| RTS,S Group | Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After Dose of Study Vaccines at 7.5 Months of Age | 109 Participants |
Secondary
Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period (Day of vaccination and 29 subsequent days) after booster dose administered at Month 21
Population: Analysis was performed on the Exposed set which included all subjects with the booster dose of study vaccine administered at 27 months of age (Coad and RTS,S Groups)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age | 62 Participants |
| RTS,S Group | Number of Subjects With Unsolicited AEs for the Coad Group and RTS,S Group, After the Booster Dose of Study Vaccine Administered at 27 Months of Age | 67 Participants |
Secondary
Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-Day Period (Day of vaccination and 29 subsequent days) after primary doses of study vaccine administered at Month 4.5, Month 5.5, Month 6.5 (across primary doses), and after booster dose administered at Month 24
Population: Analysis was performed on the Exposed set which included all subjects with at least one dose of study vaccine administered at 10.5, 11.5, 12.5 and 30 months of age (Control Group).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Coad Group | Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age | Across primary doses | 160 Participants |
| Coad Group | Number of Subjects With Unsolicited AEs for the Control Group, After Dose of Study Vaccine Administered at 10.5, 11.5, 12.5 and 30 Months of Age | At Month 24 | 57 Participants |
Secondary
Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age
An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Time frame: During the 30-day period (Day of the visit and 29 subsequent days) after the visit at Month 1.5
Population: Analysis was performed on the Exposed set which included all subjects from the Control Group who completed the visit at Month 1.5.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coad Group | Number of Subjects With Unsolicited AEs for the Control Group, at Visit at 7.5 Months of Age | 80 Participants |