Malaria
Conditions
Keywords
Vaccine, Prophylaxis Plasmodium falciparum malaria, Plasmodium falciparum, Malaria
Brief summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed description
This study will be conducted in a partially blind fashion: it will be observer-blind as to which vaccine was administered, and open as to the vaccination schedule. One group of children on the 0, 1, 2-schedule will receive a Rabies vaccine as a control. One group on the same schedule will receive the RTS,S/AS02D experimental vaccine as an active comparator.
Interventions
2 different formulations are tested. For each formulation, 3 different dosing schedules are tested
BIOLOGICALRabipur
3-dose intramuscular injection.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
5 Months to 17 Months
Healthy volunteers
Yes
Inclusion criteria
* A male or female child between 5 months and 17 months of age at the time of first vaccination. * Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child. * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
Exclusion criteria
* Acute disease at the time of enrolment. * Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests. * Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits. * Planned administration/administration of a vaccine (not in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine. * Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the study vaccine, or planned use during the study period. * Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * Simultaneous participation in any other clinical trial; * Previous participation in any other malaria vaccine trial; * Any twins * History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Serious Adverse Events (SAEs) | From Day 0 to Month 10 | Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Any and Grade 3 Solicited Local Symptoms | During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses | Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site. |
| Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses | Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination. |
| Number of Subjects With Any Unsolicited Adverse Events (AEs) | During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses | An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. |
| Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | At Day 0, at Month 2, at Month 7 and at Month 10 | Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL). |
| Titers for Anti-Hepatitis B (Anti-HBs) | At Day 0 and at Month 2 | Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL). |
Countries
Ghana
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SB257049 F2 0-1 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 2 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 90 |
| SB257049 F1 0-1 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received received 2 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 90 |
| SB257049 F2 0-1-2 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 45 |
| SB257049 F1 0-1-2 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 90 |
| Rabipur 0-1-2 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of Rabipur vaccine according to a 0, 1, 2-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 45 |
| SB257049 F2 0-1-7 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 2 (F2) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 90 |
| SB257049 F1 0-1-7 M Group Healthy infants between 5 and 17 months of age at the time of first vaccination received 3 doses of SB257049 formulation 1 (F1) vaccine according to a 0, 1, 7-month schedule administered intramuscularly (IM) in the left deltoid muscle. | 90 |
| Total | 540 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Overall Study | Death | 0 | 1 | 0 | 0 | 0 | 1 | 1 |
| Overall Study | Migrated | 4 | 1 | 3 | 1 | 4 | 1 | 1 |
| Overall Study | Other | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 1 | 1 | 1 | 0 |
Baseline characteristics
| Characteristic | SB257049 F2 0-1 M Group | SB257049 F1 0-1 M Group | SB257049 F2 0-1-2 M Group | SB257049 F1 0-1-2 M Group | Rabipur 0-1-2 M Group | SB257049 F2 0-1-7 M Group | SB257049 F1 0-1-7 M Group | Total |
|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 10.5 Months STANDARD_DEVIATION 3.4 | 10.4 Months STANDARD_DEVIATION 3.4 | 11.2 Months STANDARD_DEVIATION 3.3 | 10.9 Months STANDARD_DEVIATION 3.7 | 10.9 Months STANDARD_DEVIATION 3.5 | 10.4 Months STANDARD_DEVIATION 3.6 | 10.7 Months STANDARD_DEVIATION 3.3 | 10.7 Months STANDARD_DEVIATION 3.5 |
| Race and Ethnicity Not Collected | — | — | — | — | — | — | — | 0 Participants |
| Sex: Female, Male Female | 41 Participants | 42 Participants | 23 Participants | 40 Participants | 27 Participants | 44 Participants | 48 Participants | 265 Participants |
| Sex: Female, Male Male | 49 Participants | 48 Participants | 22 Participants | 50 Participants | 18 Participants | 46 Participants | 42 Participants | 275 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 |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 1 / 90 | 0 / 45 | 0 / 90 | 1 / 45 | 0 / 90 | 2 / 90 |
| other Total, other adverse events | 85 / 90 | 87 / 90 | 44 / 45 | 89 / 90 | 43 / 45 | 89 / 90 | 89 / 90 |
| serious Total, serious adverse events | 18 / 90 | 23 / 90 | 11 / 45 | 22 / 90 | 7 / 45 | 24 / 90 | 17 / 90 |
Outcome results
Primary
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Time frame: From Day 0 to Month 10
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB257049 F2 0-1 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 10 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 19 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 5 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 13 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 6 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 17 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Serious Adverse Events (SAEs) | 14 Participants |
Secondary
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Assessed solicited local symptoms were pain and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 swelling = swelling spreading beyond 20 millimeters (mm) of injection site.
Time frame: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 35 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 10 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 2 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 68 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 26 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 18 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 37 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 2 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 2 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 8 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 61 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 41 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 14 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 24 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 28 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 17 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 11 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 16 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 3 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 24 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 32 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 4 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 31 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 23 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 12 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 19 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 7 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 28 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 2 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 30 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 2 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 21 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 6 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 2 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 27 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 50 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 23 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 14 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 10 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 21 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 0 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 3 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 78 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 8 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 9 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 5 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 34 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 8 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 53 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 16 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 16 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 42 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 5 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 47 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 17 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 1 | 38 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 2 | 11 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Across Doses | 2 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Across Doses | 25 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Across Doses | 2 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Across Doses | 67 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 3 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 1 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 2 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 3 | 40 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 3 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 3 | 11 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Pain, Dose 2 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Swelling, Dose 1 | 15 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Any Pain, Dose 2 | 38 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any and Grade 3 Solicited Local Symptoms | Grade 3 Swelling, Dose 1 | 1 Participants |
Secondary
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever higher than (\>) 39.0 °C. Related = symptom assessed by the investigator as related to the vaccination.
Time frame: During the 7-day (Days 0 - 6) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available and who had their symptom sheets filled in.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 40 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 2 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 14 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 1 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 19 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 7 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 14 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 6 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 21 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 16 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 5 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 51 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 26 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 19 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 18 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 26 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 1 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 2 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 33 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 45 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 43 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 1 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 49 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 35 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 44 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 5 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 22 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 38 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 23 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 3 Participants |
| SB257049 F2 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 6 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 3 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 14 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 47 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 16 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 1 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 23 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 32 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 24 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 5 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 20 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 14 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 17 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 16 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 11 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 12 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 37 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 15 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 8 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 12 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 10 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 39 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 1 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 2 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 2 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 16 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 25 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 17 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 9 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 26 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 2 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 44 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 33 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 6 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 5 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 17 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 19 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 20 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 5 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 12 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 15 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 13 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 16 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 9 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 12 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 5 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 20 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 9 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 18 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 15 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 33 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 5 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 17 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 23 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 1 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 3 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 9 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 3 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 19 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 9 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 11 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 6 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 13 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 17 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 23 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 14 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 11 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 19 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 23 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 18 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 15 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 2 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 12 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 9 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 47 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 42 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 25 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 16 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 7 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 26 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 23 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 17 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 12 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 23 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 17 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 63 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 56 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 39 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 16 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 1 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 11 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 22 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 12 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 9 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 31 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 4 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 5 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 5 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 47 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 1 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 34 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 2 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 21 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 14 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 4 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 5 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 5 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 11 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 9 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 9 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 3 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 5 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 5 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 6 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 2 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 7 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 8 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 11 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 13 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 0 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 16 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 19 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 27 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 4 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 69 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 9 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 67 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 18 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 28 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 57 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 39 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 6 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 5 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 27 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 44 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 2 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 10 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 42 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 17 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 16 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 2 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 0 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 21 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 28 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 10 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 43 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 28 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 8 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 48 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 2 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 9 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 50 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 8 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 1 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 36 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 21 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 13 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 16 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 21 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 46 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 63 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 35 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 4 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Across Doses | 3 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Across Doses | 39 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Across Doses | 29 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 3 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 3 | 16 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 1 | 10 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 2 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Across Doses | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 3 | 14 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 2 | 10 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 1 | 23 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 3 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Across Doses | 73 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 2 | 46 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 1 | 26 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Across Doses | 33 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 2 | 18 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 1 | 15 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 3 | 3 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 2 | 3 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 1 | 7 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 3 | 25 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Across Doses | 32 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Dose 1 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Fever, Across Doses | 7 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 3 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Across Doses | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 1 | 18 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 2 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 2 | 41 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 2 | 14 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Across Doses | 39 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Dose 2 | 22 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 1 | 18 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 3 | 25 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Drowsiness, Dose 3 | 16 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Irritability, Dose 2 | 16 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Loss of appetite, Dose 1 | 1 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 2 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Irritability, Across Doses | 45 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Fever, Dose 3 | 51 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Drowsiness, Dose 1 | 0 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Across Doses | 64 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Drowsiness, Dose 2 | 13 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Loss of appetite, Dose 1 | 11 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Related Fever, Dose 3 | 50 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Any Loss of appetite, Dose 3 | 16 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms | Grade 3 Irritability, Dose 1 | 1 Participants |
Secondary
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Time frame: During the 30-day (Days 0 - 29) post-vaccination period following each dose and across doses
Population: The analyses were performed on the Total Vaccinated cohort, which included all vaccinated subjects for whom data are available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| SB257049 F2 0-1 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 78 Participants |
| SB257049 F1 0-1 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 82 Participants |
| SB257049 F2 0-1-2 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 40 Participants |
| SB257049 F1 0-1-2 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 80 Participants |
| Rabipur 0-1-2 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 41 Participants |
| SB257049 F2 0-1-7 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 84 Participants |
| SB257049 F1 0-1-7 M Group | Number of Subjects With Any Unsolicited Adverse Events (AEs) | 85 Participants |
Secondary
Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS)
Titers are presented as geometric mean titers (GMTs) and expressed in enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Time frame: At Day 0, at Month 2, at Month 7 and at Month 10
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB257049 F2 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F2 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 318.4 EL.U/mL |
| SB257049 F2 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 34.5 EL.U/mL |
| SB257049 F2 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 19.9 EL.U/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 30.5 EL.U/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 52.7 EL.U/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 483.4 EL.U/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 78.2 EL.U/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 366.9 EL.U/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 43.4 EL.U/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 631.8 EL.U/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 162.3 EL.U/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 102.1 EL.U/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 0.3 EL.U/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 0.4 EL.U/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 0.3 EL.U/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 25.9 EL.U/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 272.1 EL.U/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 120.0 EL.U/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 7 | 373.0 EL.U/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Day 0 | 0.3 EL.U/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 2 | 51.0 EL.U/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) | Month 10 | 166.5 EL.U/mL |
Secondary
Titers for Anti-Hepatitis B (Anti-HBs)
Titers are presented as geometric mean titers (GMTs) and expressed in milli-international units per milliliter (mIU/mL).
Time frame: At Day 0 and at Month 2
Population: The analyses were performed on the According-To-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom data concerning immunogenicity outcome measures were available.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| SB257049 F2 0-1 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 17042.9 mIU/mL |
| SB257049 F2 0-1 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 100.8 mIU/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 107.6 mIU/mL |
| SB257049 F1 0-1 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 15106.5 mIU/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 108.7 mIU/mL |
| SB257049 F2 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 29999.7 mIU/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 82.1 mIU/mL |
| SB257049 F1 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 34935.1 mIU/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 121.7 mIU/mL |
| Rabipur 0-1-2 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 107.9 mIU/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 88.1 mIU/mL |
| SB257049 F2 0-1-7 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 96754.4 mIU/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Day 0 | 89.9 mIU/mL |
| SB257049 F1 0-1-7 M Group | Titers for Anti-Hepatitis B (Anti-HBs) | Month 2 | 103224.8 mIU/mL |