Malaria
Conditions
Keywords
Africa, malaria vaccine, schedule, EPI, Plasmodium falciparum
Brief summary
The aim of the malaria vaccine program of the MVI/GSK partnership is to develop an efficacious malaria vaccine that is deliverable through the existing system, the Expanded Program on Immunization (EPI) of WHO. This study has been designed to: * Investigate the safety and immunogenicity of 7 infant immunization schedules of the experimental malaria vaccine integrated with an EPI regimen. * Investigate how to maximize the antibody response to the experimental malaria vaccine.
Interventions
3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=\<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =\< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
BIOLOGICALEngerix-B
1 dose, intramuscular route: left antero-lateral thigh at birth (=\< 7 days of age)
BIOLOGICALTritanrix HepB Hib
3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
BIOLOGICALBCG
1 dose, intradermal route, in shoulder at birth (=\< 7 days of age)
BIOLOGICALOPV
4 doses, orally, at birth (=\< 7 days of age) and at 6, 10 and 14 weeks of age
BIOLOGICALRouvax
1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
Sponsors
The PATH Malaria Vaccine Initiative (MVI)
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 7 Days
Healthy volunteers
Yes
Inclusion criteria
All subjects must satisfy the following criteria at study entry: * A male or female infant between 1 and 7 days (inclusive) of age (where day 1 is day of birth). * Signed or thumb-printed informed consent obtained from the parent(s)/guardian(s) of the child. Where parent(s)/guardian(s) are illiterate, the consent form will be countersigned by a witness. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol (e.g. return for follow-up visits) should be enrolled in the study. * Born to a mother negative for HIV antibody and Hepatitis B surface antigen. * Subjects who are born after a normal gestation period (between 37 and 42 weeks) (Gestational age will be determined by carrying out a clinical assessment on infants according to the principles set out by Dubowitz (1970) in the first 5 days of life). * A minimum weight of 2.5 kg.
Exclusion criteria
The following criteria should be checked at the time of study entry. If any apply, the subject must not be included in the study: * Acute or chronic illness determined by clinical or physical examination and laboratory screening tests including, but not limited to: * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects. * History of any neurological disorders or seizures. * Laboratory screening tests out of normal ranges/limits defined per protocol. * Previous vaccination with diphtheria, tetanus, pertussis (whole-cell or acellular), Hemophilus influenzae type b, hepatitis B, BCG tuberculosis, measles or oral polio vaccines. * Planned administration/administration of a licensed vaccine (i.e. a vaccine that is approved by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) not foreseen by the study protocol within 7 days of the first dose of study vaccine. * Administration of immunoglobulins, blood transfusions or other blood products since birth to the first dose of study vaccine or planned administration during the study period. * Use of a drug or vaccine that is not approved for that indication (by one of the following authorities: FDA or EU member state or WHO \[with respect to prequalification\]) other than the study vaccine starting at birth or planned use during the study period. * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth. * Simultaneous participation in any other clinical trial. * Same-sex twins (to avoid misidentification). * Maternal death. * History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Children will not be enrolled if any maternal, obstetrical or neonatal event that has occurred might, in the judgment of the investigator, result in increased neonatal/infant morbidity * Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reported With Serious Adverse Events (SAEs) | From study start at Month 0 up to Month 10. | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. |
| Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups | Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reported With Serious Adverse Events (SAEs) | From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015) | An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity. |
| Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14). | This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT\< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as \> 10.0 times the ULN. |
| Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14). | This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN. |
| Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14). | This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE \> 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE \< 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE \< 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE \< 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE \< 7.0 g/dL. |
| Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14). | This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as \> 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as \< 25 Billions PLA/L. |
| Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14). | This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as \> 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as \< 1.0 Billions WBC/L. |
| Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group | Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL. |
| Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | At Month 5 | Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL. |
| Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | At Month 5 | Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL. |
| Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | At Month 5 | Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL. |
| Concentrations of Antibodies Against Acellular B-pertussis (BPT) | At Month 5 | Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL. |
| Concentrations of Antibodies Against Measles Antigens | At Month 10 | Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL). The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups. |
| Number of Subjects Reported With Solicited Local Symptoms | Within 7 days (Days 0-6) after Week 0 vaccination | Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity. |
| Number of Subjects Reported With Solicited General Symptoms | Within 7 days (Days 0-6) after Week 0 vaccination | Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. |
| Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling | Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively. |
| Number of Subjects Reported With Unsolicited Adverse Events (AEs) | During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group | An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | At Month 18 post vaccination | Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results. |
| Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | At Month 18 post vaccination | Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results. |
Countries
Malawi
Participant flow
Recruitment details
480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.
Pre-assignment details
480 subjects were enrolled into the study. Out of these 480 subjects, 479 were vaccinated and 1 was allocated a subject number but was not vaccinated.
Participants by arm
| Arm | Count |
|---|---|
| RTS,S Neo-10-14 Group Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| RTS,S Neo-10-26 Group Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 59 |
| RTS,S 6-10-14 Group Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| RTS,S 6-10-26 Group Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| Engerix-B Neo/RTS,S 6-10-26 Group Subjects received one dose of Engerix-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| RTS,S 10-14-26 Group Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of TritanrixHepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| RTS,S 14-26-9M Group Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| Engerix-B Neo Group Subjects in this group received one dose of Engerix-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder. | 60 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Overall Study | Adverse event, serious fatal | 0 | 0 | 1 | 1 | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 8 | 10 | 8 | 5 | 7 | 9 | 6 | 6 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 3 | 3 | 1 | 3 | 5 | 1 | 2 |
Baseline characteristics
| Characteristic | RTS,S Neo-10-14 Group | RTS,S Neo-10-26 Group | RTS,S 6-10-14 Group | RTS,S 6-10-26 Group | Engerix-B Neo/RTS,S 6-10-26 Group | RTS,S 10-14-26 Group | RTS,S 14-26-9M Group | Engerix-B Neo Group | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 0.4 Days STANDARD_DEVIATION 1.1 | 0.4 Days STANDARD_DEVIATION 1.2 | 0.2 Days STANDARD_DEVIATION 1 | 0.2 Days STANDARD_DEVIATION 0.8 | 0.5 Days STANDARD_DEVIATION 1.4 | 0.2 Days STANDARD_DEVIATION 0.8 | 0.2 Days STANDARD_DEVIATION 0.9 | 0.4 Days STANDARD_DEVIATION 1.2 | 0.3 Days STANDARD_DEVIATION 1.03 |
| Sex: Female, Male Female | 30 Participants | 32 Participants | 28 Participants | 35 Participants | 31 Participants | 29 Participants | 24 Participants | 28 Participants | 237 Participants |
| Sex: Female, Male Male | 30 Participants | 27 Participants | 32 Participants | 25 Participants | 29 Participants | 31 Participants | 36 Participants | 32 Participants | 242 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 59 | 0 / 60 | 0 / 60 | 0 / 60 | 1 / 60 | 0 / 60 | 0 / 60 |
| other Total, other adverse events | 36 / 60 | 35 / 59 | 28 / 58 | 29 / 60 | 35 / 60 | 36 / 59 | 47 / 60 | 31 / 59 |
| serious Total, serious adverse events | 7 / 60 | 5 / 59 | 6 / 60 | 9 / 60 | 8 / 60 | 12 / 60 | 5 / 60 | 4 / 60 |
Outcome results
Primary
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M5 for RTS,S Neo-10-14, RTS,S 6-10-14 and Engerix-B Neo groups
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 128.2 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 218.3 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 0 EL.U/mL |
Primary
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M7 for RTS,S Neo-10-26, RTS,S 6-10-26, Engerix-B Neo/RTS,S 6-10-26, and RTS,S 10-14-26 groups
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 136.6 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 156.5 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 170.6 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 392.6 EL.U/mL |
Primary
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off for the endpoint was a GMC value greater than or equal to (≥) 0.5 EL.U/mL.
Time frame: At 1 month (M) post Dose 3 of RTS,S/AS01E, e. a. M10 for RTS,S 14-26-9M Group
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 269.9 EL.U/mL |
Primary
Number of Subjects Reported With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity.
Time frame: From study start at Month 0 up to Month 10.
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 4 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 5 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 7 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 5 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 10 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 4 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 3 Participants |
Secondary
Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations
Anti-D and anti-TT antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in International units per milliliter (IU/mL), and tabulated. The seropositivity cut-off value for the assay was ≥ 0.1 IU/mL.
Time frame: At Month 5
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 3.1 IU/mL |
| RTS,S Neo-10-14 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.5 IU/mL |
| RTS,S Neo-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.2 IU/mL |
| RTS,S Neo-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 3.9 IU/mL |
| RTS,S 6-10-14 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.7 IU/mL |
| RTS,S 6-10-14 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 3.2 IU/mL |
| RTS,S 6-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 4.0 IU/mL |
| RTS,S 6-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 2.8 IU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.3 IU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 3.6 IU/mL |
| RTS,S 10-14-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 4.3 IU/mL |
| RTS,S 10-14-26 Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.3 IU/mL |
| RTS,S 14-26-9M Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 4.3 IU/mL |
| RTS,S 14-26-9M Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 3.5 IU/mL |
| Engerix-B Neo Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-D | 4.6 IU/mL |
| Engerix-B Neo Group | Anti-diphtheria (Anti-D) and Anti-tetanus Toxoids (Anti-TT) Antibody Concentrations | Anti-TT | 4.6 IU/mL |
Secondary
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations.
Concentrations, by enzyme-linked immunosorbent assay (ELISA), were presented as geometric mean concentrations (GMCs), and expressed in milli-international units per milliliter (mIU/mL). The seropositivity and seroprotection cut-off values for the assay were greater than or equal to (≥) 6.2 and 10 mIU/mL, respectively.
Time frame: At Screening (SCR), at Month 5 (M5), at Month 7 (M7) and at Month 10 (M10), according to the vaccination scheduling
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 10.7 mIU/mL |
| RTS,S Neo-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 2949.5 mIU/mL |
| RTS,S Neo-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M5 | 6479.0 mIU/mL |
| RTS,S Neo-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 9630.8 mIU/mL |
| RTS,S Neo-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 22.2 mIU/mL |
| RTS,S Neo-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M7 | 23218.5 mIU/mL |
| RTS,S 6-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 9.9 mIU/mL |
| RTS,S 6-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 3135.0 mIU/mL |
| RTS,S 6-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M5 | 3831.6 mIU/mL |
| RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M7 | 29839.9 mIU/mL |
| RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 9.5 mIU/mL |
| RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 8581.8 mIU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M7 | 34589.1 mIU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 17.2 mIU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 12084.3 mIU/mL |
| RTS,S 10-14-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 13360.1 mIU/mL |
| RTS,S 10-14-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 12.6 mIU/mL |
| RTS,S 10-14-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M7 | 44472.4 mIU/mL |
| RTS,S 14-26-9M Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 38.6 mIU/mL |
| RTS,S 14-26-9M Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 75018.0 mIU/mL |
| Engerix-B Neo Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M10 | 139.5 mIU/mL |
| Engerix-B Neo Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | SCR | 22.6 mIU/mL |
| Engerix-B Neo Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M5 | 640.7 mIU/mL |
| Engerix-B Neo Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations. | M7 | 430.1 mIU/mL |
Secondary
Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations
Anti-Polio 1, 2 and 3 antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in international units per mililiter (IU/mL) and tabulated. The seroprotection cut-off value for the assay was ≥ 8 IU/mL.
Time frame: At Month 5
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity included all subjects included in the Total Vaccinated cohort who received all vaccinations according to protocol procedures within specified intervals and did not take any immune modifying medication or had blood transfusions.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 27.6 IU/mL |
| RTS,S Neo-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 3.6 IU/mL |
| RTS,S Neo-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 27.5 IU/mL |
| RTS,S Neo-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 2.3 IU/mL |
| RTS,S Neo-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 35.1 IU/mL |
| RTS,S Neo-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 21.6 IU/mL |
| RTS,S 6-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 5.1 IU/mL |
| RTS,S 6-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 31.7 IU/mL |
| RTS,S 6-10-14 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 56.6 IU/mL |
| RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 47.1 IU/mL |
| RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 37.9 IU/mL |
| RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 3.3 IU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 42 IU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 19.9 IU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 5.6 IU/mL |
| RTS,S 10-14-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 27.6 IU/mL |
| RTS,S 10-14-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 23.6 IU/mL |
| RTS,S 10-14-26 Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 2.6 IU/mL |
| RTS,S 14-26-9M Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 40.1 IU/mL |
| RTS,S 14-26-9M Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 16.7 IU/mL |
| RTS,S 14-26-9M Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 3 IU/mL |
| Engerix-B Neo Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 1 | 45.4 IU/mL |
| Engerix-B Neo Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 2 | 25.9 IU/mL |
| Engerix-B Neo Group | Anti-polio Type 1, 2 and 3 (Anti-Polio 1, 2 and 3) Antibody Concentrations | Anti-Polio 3 | 6 IU/mL |
Secondary
Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations
Anti-PRP antibody concentrations were calculated, expressed as geometric mean concentrations (GMCs), in microgram per milliliter (µg/mL), and tabulated. The seroprotection cut-off value for the assay was ≥ 0.15 µg/mL.
Time frame: At Month 5
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 6.8 µg/mL |
| RTS,S Neo-10-26 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 11.1 µg/mL |
| RTS,S 6-10-14 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 11.4 µg/mL |
| RTS,S 6-10-26 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 13.6 µg/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 10.9 µg/mL |
| RTS,S 10-14-26 Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 11.0 µg/mL |
| RTS,S 14-26-9M Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 15.6 µg/mL |
| Engerix-B Neo Group | Anti-polyribosyl Ribitol Phosphate (Anti-PRP) Antibody Concentrations | 13.8 µg/mL |
Secondary
Concentrations of Antibodies Against Acellular B-pertussis (BPT)
Concentrations of anti-BPT antibodies were determined by enzyme-linked immunosorbent assay (ELISA) and expressed as geometric mean concentrations (GMCs), in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was ≥ 15 EL.U/mL.
Time frame: At Month 5
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 82.9 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 102.3 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 86.7 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 81.2 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 99.2 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 86.1 EL.U/mL |
| RTS,S 14-26-9M Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 91.0 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Acellular B-pertussis (BPT) | 109.8 EL.U/mL |
Secondary
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Anti-CS antibody concentrations were determined by enzyme-linked immunosorbent assay (ELISA) and presented as geometric mean concentrations (GMCs) expressed in ELISA units per milliliter (EL.U/mL). The seropositivity cut-off value for the assay was greater than or equal to (≥) 0.5 EL.U/mL.
Time frame: At Screening (SCR), at Month (M) 4, at M5, at M7 and/or at M10, according to the vaccination scheduling for the specific group assessed concerned group
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 33.6 EL.U/mL |
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 13.8 EL.U/mL |
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M5 | 128.2 EL.U/mL |
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.5 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 136.6 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 72.8 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 39.5 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M5 | 218.3 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 112.2 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 30.1 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 44.2 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 156.5 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 99.7 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 43.3 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 88.0 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 170.6 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M5 | 167.6 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 392.6 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 121.0 EL.U/mL |
| RTS,S 14-26-9M Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 141.7 EL.U/mL |
| RTS,S 14-26-9M Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 269.9 EL.U/mL |
| RTS,S 14-26-9M Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.4 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M4 | 0 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M7 | 0 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M5 | 0 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at SCR | 0.5 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | Anti-CS, at M10 | 0.3 EL.U/mL |
Secondary
Concentrations of Antibodies Against Measles Antigens
Concentrations of anti measles antibodies were determined by ELISA and expressed as GMCs in milli-international units per millilitre (mIU/mL). The seropositivity cut-off value for the assay was ≥ 150 mIU/mL. Please note that this outcome measure was only assessed in subjects in the RTS,S 14-26-9M and Engerix-B Neo groups.
Time frame: At Month 10
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Measles Antigens | 1017.7 mIU/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Measles Antigens | 1430.6 mIU/mL |
Secondary
Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter
This outcome measure concerns biochemical abnormalities, for the alanine aminotransferase (ALT) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal ALT level was defined as ALT\< 60 International units per milliliter (IU/mL). Grade 1 ALT level was defined as 1.1 to 2.5 times the upper limit of normal (ULN). Grade 2 ALT level was defined as 2.6 to 5.0 times the ULN. Grade 3 ALT level was defined as 5.1 to 10.0 times the ULN. Grade 4 ALT level was defined as \> 10.0 times the ULN.
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 48 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 2 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 56 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 49 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 55 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 49 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 51 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 52 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 55 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 55 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 52 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 52 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 47 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 51 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 1 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 56 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 1 | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Normal | 50 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Missing | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 7D+W6, Normal | 57 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Alanine Aminotransferase (ALT) Parameter | 30D+W14, Grade 2 | 0 Participants |
Secondary
Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter
This outcome measure concerns biochemical abnormalities, for the creatinine (CREA) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal CREA level was defined as CREA ≤ 106, 88 and 71 micromoles per liter (µmol/L) for subjects 1, 2 or ≥ 2 days of age, respectively. Grade 1 CREA level was defined as 1.1 to 1.3 times the upper limit of normal (ULN). Grade 2 CREA level was defined as 1.4 to 1.8 times the ULN. Grade 3 CREA level was defined as 1.9 to 3.4 times the ULN. Grade 4 CREA level was defined as ≥ 3.5 times the ULN.
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 50 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 3 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 55 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 55 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 49 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 53 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 50 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 52 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 53 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 57 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 53 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 47 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 51 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Normal | 56 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Normal | 50 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Missing | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Missing | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Biochemical Abnormalities, for the Creatinine (CREA) Parameter | 30D+W14, Grade 3 | 0 Participants |
Secondary
Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter
This outcome measure concerns haematological abnormalities, for the haemoglobin (HAE) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G 2, G 3, G 4 or Missing. Normal HAE level was defined as HAE \> 13.0 and 10.5 grams per deciliter (g/dL) for subjects aged 1 to 21 and 22 to 35 days respectively. Grades were defined as follows: 1) In subjects aged 1 to 21 days: G1 = HAE as 12.0 to 13.0 g/dL, G2 = HAE as 10.0 to 11.9 g/dL, G3 = HAE as 9.0 to 9.9 g/dL, G4 = HAE \< 9.0 g/dL; 2) In subjects aged 22 to 35 days: G1 = HAE as 9.5 to 10.5 g/dL, G2 = HAE as 8.0 to 9.4 g/dL, G3 = HAE as 7.0 to 7.9 g/dL, G4 = HAE \< 7.0 g/dL; 3) In subjects aged 36 to 56 days: G1 = HAE as 8.5 to 9.4 g/dL, G2 = HAE as 7.0 to 8.4 g/dL, G3 = HAE as 6.0 to 6.9 g/dL, G4 = HAE \< 6.0 g/dL; 4) In subjects aged ≥ 57 days: G1 = HAE as 10.0 to 10.9 g/dL, G2 = HAE as 9.0 to 9.9 g/dL, G3 = HAE as 7.0 to 8.9 g/dL, G4 = HAE \< 7.0 g/dL.
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 16 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 25 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 51 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 5 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 3 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 7 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 4 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 17 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 15 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 11 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 6 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 47 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 23 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 10 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 16 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 5 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 43 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 13 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 5 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 7 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 50 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 18 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 15 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 7 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 12 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 26 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 11 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 4 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 48 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 45 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 18 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 6 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 6 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 15 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 8 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 9 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 8 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 12 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 25 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 21 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 19 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 15 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 1 | 24 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Normal | 48 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 2 | 6 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 3 | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 3 | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 2 | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 30D+W14, Normal | 20 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 1 | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Haemoglobin (HAE) Parameter | 7D+W6, Grade 4 | 1 Participants |
Secondary
Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter
This outcome measure concerns haematological abnormalities, for the platelets (PLA) parameter. Subjects' levels were assessed as either normal, Grade (G) 1, G2, G3, G4 or Missing. Normal PLA level was defined as \> 125 x 10 exp 9 PLA per liter (Billions PLA/L). Grade 1 PLA level was defined as 100 to 125 Billions PLA/L. Grade 2 PLA level was defined as 50 to 99 Billions PLA/L. Grade 3 PLA level was defined as 25 to 49 Billions PLA/L. Grade 4 PLA level was defined as \< 25 Billions PLA/L.
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 54 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 51 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 3 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 55 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 49 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 47 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 46 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 53 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 55 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 51 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 45 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 53 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 53 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Normal | 51 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Normal | 51 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 1 | 5 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 2 | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 7D+W6, Grade 2 | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the Platelets (PLA) Parameter | 30D+W14, Grade 1 | 0 Participants |
Secondary
Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter
This outcome measure concerns haematological abnormalities, for the white blood cells (WBC) parameter. Subjects' levels were assessed as either normal, Grade 1, Grade 2, Grade 3, Grade 4 or Missing. Normal WBC level was defined as \> 2.5 x 10 exp 9 WBC per liter (Billions WBC/L). Grade 1 WBC level was defined as 2.0 to 2.5 Billions WBC/L. Grade 2 WBC level was defined as 1.5 to 1.999 Billions WBC/L. Grade 3 WBC level was defined as 1.0 to 1.499 Billions WBC/L. Grade 4 WBC level was defined as \< 1.0 Billions WBC/L.
Time frame: At Day 7 post dose 1 (7D+W6) and at Day 30 post dose 3 (30D+W14).
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 51 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 49 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 50 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 3 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 50 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 56 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 53 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 53 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 57 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 47 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 54 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 54 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 57 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 1 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 2 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Normal | 52 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 3 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 2 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Normal | 58 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Grade 4 | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 30D+W14, Missing | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Haematological Abnormalities, for the White Blood Cells (WBC) Parameter | 7D+W6, Grade 1 | 0 Participants |
Secondary
Number of Subjects Reported With Serious Adverse Events (SAEs)
An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or may evolve into one of the outcomes listed above. Any is defined an incidence of a SAE regardless of intensity/severity.
Time frame: From study start at Month 0 up to Month 18 (corresponding data lock point =23 March 2015)
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 7 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 5 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 6 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 9 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 8 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 12 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 5 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Serious Adverse Events (SAEs) | 4 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after Week 6 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 6 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 9 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 6 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 3 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 3 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 9 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after Week 14 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 4 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 9 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 4 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 3 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after Week 0 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 8 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 9 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 6 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 3 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 1 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 1 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive any vaccination at this time point
Time frame: Within 7 days (Days 0-6) after Week 26 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 8 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after Month 9 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 1 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 6 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 3 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 1 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 1 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 10 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
Secondary
Number of Subjects Reported With Solicited General Symptoms
Solicited general symptoms assessed include Drowsiness, Fever (temperature by axillary route ≥ 37.5°C), Irritability/Fussiness and Loss of appetite. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity or relationship to vaccination.
Time frame: Within 7 days (Days 0-6) after Week 10 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 3 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 11 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 6 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 6 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 4 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 7 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Irritability/Fussiness | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Loss of appetite | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Fever | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited General Symptoms | Any Drowsiness | 0 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Time frame: Within 7 days (Days 0-6) after Week 10 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 2 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 1 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 5 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 6 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 5 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Time frame: Within 7 days (Days 0-6) after Week 0 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 2 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 1 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 5 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 5 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 6 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 7 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 5 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 5 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 8 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 11 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 1 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 6 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Time frame: Within 7 days (Days 0-6) after Week 6 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 2 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 2 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 7 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 6 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 8 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 7 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 3 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 6 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 5 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 6 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 6 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Time frame: Within 7 days (Days 0-6) after Week 14 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 7 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 5 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 5 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 4 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 1 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 1 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 4 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 2 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 4 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 3 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 1 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 2 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 2 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 3 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 3 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity. RTS,S Neo-10-14 Group, RTS,S 6-10-14 Group and Engerix-B Neo Group didn't receive vaccination at this time point.
Time frame: Within 7 days (Days 0-6) after Week 26 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
Secondary
Number of Subjects Reported With Solicited Local Symptoms
Solicited local symptoms assessed include pain, redness and swelling. Any about a specific symptom is defined as incidence of this symptom, regardless of its intensity.
Time frame: Within 7 days (Days 0-6) after Month 9 vaccination
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Pain | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Redness | 0 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Solicited Local Symptoms | Any Swelling | 0 Participants |
Secondary
Number of Subjects Reported With Unsolicited Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any is defined an incidence of an unsolicited AE regardless of intensity or relationship to study vaccination. Please note that, for this outcome measure, analysis was performed only on subjects with at least one administered dose of RTS,S/AS01E and/or DTPwHepB/Hib for the Engerix-B Neo Group.
Time frame: During the 30-day (Days 0-29) post vaccination period following 3 doses of RTS,S/AS01E versus DTPwHepB/Hib for the Engerix-B Neo Group
Population: Analysis was done on the Total Vaccinated cohort, which included all subjects who were randomized and received a dose of BCG tuberculosis vaccine. Analyses on this cohort were performed per treatment assignment. This analysis was done solely on subjects for whom data were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| RTS,S Neo-10-14 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 36 Participants |
| RTS,S Neo-10-26 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 35 Participants |
| RTS,S 6-10-14 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 28 Participants |
| RTS,S 6-10-26 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 29 Participants |
| Engerix-B Neo/RTS,S 6-10-26 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 35 Participants |
| RTS,S 10-14-26 Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 36 Participants |
| RTS,S 14-26-9M Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 47 Participants |
| Engerix-B Neo Group | Number of Subjects Reported With Unsolicited Adverse Events (AEs) | 31 Participants |
Other Pre-specified
Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations
Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.
Time frame: At Month 18 post vaccination
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 1656.6 mIU/mL |
| RTS,S Neo-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 3509.9 mIU/mL |
| RTS,S 6-10-14 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 1823.1 mIU/mL |
| RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 4208.4 mIU/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 4725.7 mIU/mL |
| RTS,S 10-14-26 Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 7341.5 mIU/mL |
| RTS,S 14-26-9M Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 12045.3 mIU/mL |
| Engerix-B Neo Group | Anti-Hepatitis B Surface Antibody (Anti-HBs) Concentrations | 78 mIU/mL |
Other Pre-specified
Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies)
Month 18 immunogenicity data were tertiary objectives, and although not required to be disclosed were included in this result summary at the request of the study team to show the full study immunogenicity results.
Time frame: At Month 18 post vaccination
Population: Analysis was done on the According-to-Protocol cohort for immunogenicity, that is, subjects from the Total Vaccinated cohort who received all vaccinations, complied to protocol procedures, and for whom results were available for the antibody concentrations/titers assessed in the specified outcome measure.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| RTS,S Neo-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 5.1 EL.U/mL |
| RTS,S Neo-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 12.7 EL.U/mL |
| RTS,S 6-10-14 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 12 EL.U/mL |
| RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 16.2 EL.U/mL |
| Engerix-B Neo/RTS,S 6-10-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 14.3 EL.U/mL |
| RTS,S 10-14-26 Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 33.8 EL.U/mL |
| RTS,S 14-26-9M Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 49.3 EL.U/mL |
| Engerix-B Neo Group | Concentrations of Antibodies Against Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS Antibodies) | 0.3 EL.U/mL |