Malaria, Plasmodium Falciparum Infection
Conditions
Keywords
monoclonal, antibody, Kenya, malaria, children
Brief summary
The purpose of this study is to evaluate the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission.
Detailed description
A two-part, phase 2 trial evaluating the safety and tolerability of one-time subcutaneous (SC) administration of monoclonal antibody (MAb) L9LS in healthy Kenyan children aged 5 months to 10 years, as well as the protective efficacy of one or two doses of L9LS against naturally occurring Plasmodium falciparum (Pf) infection among Kenyan children aged 5 to 59 months at enrollment, in a setting of perennial high transmission. Part 1 includes part 1a and part 1b and is an age de-escalation and dose-escalation study. In part 1a, in a stepwise fashion, children aged 5-10 years will receive 5 mg/kg of L9LS or placebo and be followed for 3 months to assess tolerability and safety. If acceptable tolerability and safety profiles are met at 1-week post-injection, the 5 mg/kg dose of L9LS or placebo will be administered to children aged 5-59 months while enrolling another cohort of children aged 5-10 years at a dose of 10 mg/kg of L9LS or placebo. If after 1 week, the 10 mg/kg dose is found to be safe in children aged 5-10 years and the 5 mg/kg dose is found to be safe in children aged 5-59 months, a 20 mg/kg dose of L9LS or placebo will be administered to children aged 5-10 years and a 10 mg/kg dose of L9LS or placebo to children aged 5-59 months. Finally, if these doses are found safe after 1 week, a 20 mg/kg dose of L9LS or placebo will be administered to children aged 5-59 months. Should tolerability and safety of all doses be acceptable in children aged 5-59 months, part 2 of the trial will begin. Part 1b of the study was added later and will include two additional dose escalation cohorts of children aged 5 to 71 months and will test 30 mg/kg L9LS and 40 mg/kg L9LS. Dosing in part 1 of the study will be weight-based and all doses will be administered SC in a double-blinded fashion. 12 participants in each age-dose group will be enrolled in a 3:1 ratio of L9LS to placebo, and all participants will be followed for a total of 3 months. Part 2 is the efficacy study. Children 5-59 months of age will be randomized to receive a 10-20 mg/kg dose of L9LS or placebo by SC administration. There will be two L9LS cohorts, one 5-17 months of age and another 18-59 months of age, which will constitute one L9LS arm. A placebo arm will be composed of children 5-59 months of age. They will be followed over 12 months with monthly blood smear microscopy and polymerase chain reaction (PCR) and twice-monthly symptomatology and careseeking behavior questionnaires. Dosing will be based on three weight bands; all doses will be administered SC with fixed doses of 75 mg L9LS, 150 mg L9LS, or 225 Mg L9LS, resulting in a range of 10-20 mg/kg in a double-blinded fashion. Blood will be drawn to assess antibody titers at baseline, and at three additional time points over 12 months to establish pharmacokinetics (PK). Participants in the L9LS arm will be randomized 1:1 at baseline to receive either a second L9LS injection or a placebo injection to evaluate the additional efficacy of a second dose administered 6 months after the first dose. (Those in the placebo arm will receive a second injection of placebo.) Participants will be followed for an additional 6 months after the second injection with monthly blood smear microscopy and PCR, and a blood draw at month 11 to assess L9LS PK.
Interventions
DRUGL9LS
Administered subcutaneously.
OTHERPlacebo
Normal saline administered subcutaneously.
Sponsors
Centers for Disease Control and Prevention
National Institutes of Health (NIH)
Kenya Medical Research Institute
Liverpool School of Tropical Medicine
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
5 Months to 10 Years
Healthy volunteers
Yes
Inclusion criteria
Healthy children aged 5 months to 10 years (Part 1) or 5-59 months (Part 2). Weight ≥5 kg and weight ≤30 kg (Part 1) or weight ≥5 kg and ≤22.5 kg (Part 2) or weight ≥5 kg and ≤20 kg (for 30 mg/kg group) or weight ≥5 kg and ≤15 kg (for 40 mg/kg group), to ensure a maximum volume of two 2-mL (Part 1b) Hemoglobin level ≥8 g/dL. Height and weight Z-scores \>-2. Living within Alego-Usonga sub-county. Able to participate for the duration of the trial. Parent and/or guardian of participant able to provide informed consent.
Exclusion criteria
Individuals meeting any of the following criteria will be excluded from study participation: Taking long-term cotrimoxazole. Participation or planned participation in any other interventional trial with an investigational product prior to the last required protocol visit or receipt of an investigational product within the past 30 days. (Note: Past, current, or planned participation in observational studies is NOT exclusionary.) Received any doses of any malaria vaccine. Participation in part 1 of this study (for individuals being screened for enrollment into part 2) Age \< 12 months at the time the RTS,S/AS01 vaccine is anticipated to become available in the whole of Siaya County Current significant medical condition (neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, renal, oncologic, or hematological) or evidence of any serious underlying medical condition identified by medical history, physical examination, or laboratory examination. Known sickle cell disease. (Note: Known sickle cell trait is NOT exclusionary.) White blood cell, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. Subjects may be included at the investigator's discretion for values that are not clinically significant (ie., do not require any repeat or follow-up). Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Subjects may be included at the investigator's discretion for values that are not clinically significant.) Infected with HIV. History of a severe allergic reaction or anaphylaxis. Severe asthma (defined as asthma that is unstable or required emergency care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years). Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia. Known immunodeficiency syndrome. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of day 0. Known asplenia or functional asplenia. Clinical signs of malnutrition. Receipt of immunoglobulins and/or blood products within the past 6 months. Any history of menses. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the subject to understand and comply with the study protocol. Parental/guardian study comprehension examination score of \<80% correct or per investigator discretion. Receipt of a live vaccine or a killed vaccine within the past 2 weeks prior to study agent administration. Known allergies or contraindication to dihydroartemisinin-piperaquine. Use or known need at the time of pre-enrolment (DP administration) of concomitant prohibited medication, including: Antimicrobial agents of the following classes (systemic use only): Macrolides (e.g. erythromycin, clarithromycin, azithromycin, roxithromycin) Fluoroquinolones (e.g., levofloxacin, moxifloxacin, sparfloxacin) Pentamidine Antiarrhythmic agents (e.g. amiodarone, sotalol) Antihistamines (e.g. promethazine) Antifungals (systemic): ketoconazole, fluconazole, itraconazole Antiretrovirals: Saquinavir Diuretics (e.g. hydrochlorothiazide, furosemide) Antipsychotics (neuroleptics): haloperidol, thioridazine Antidepressants: imipramine, citalopram, escitalopram Antiemetics: domperidone, chlorpromazine, ondansetron Increased risk of salivary gland hypofunction (dryness of the mouth, swelling under the tongue and/or below the ear, halitosis) History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives, or other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a subject participating in the trial, interfere with the evaluation of the study objectives, or render the subject unable to comply with the protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Local Adverse Events (AEs) | Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention) | Number of participants with at least one solicited local adverse events occurring within seven days of administration of intervention. Local reactogenicity included injection site pain, tenderness, bruising, swelling, redness, induration, pruritus, and other (e.g. injection site reaction). Adverse events were captured by Investigator examination and history from participants. |
| Number of Participants With Local Adverse Events (AEs) (by Grade) | Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention) | The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death |
| Number of Participants With Systemic Adverse Events (AEs) | Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention) | Number of participants with local adverse events occurring within seven days of administration of intervention. Systemic reactogenicity events included pyrexia (fever), malaise (feeling unusually tired or unwell), muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants. |
| Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention) | The severity of systemic adverse events occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death |
Countries
Kenya
Participant flow
Pre-assignment details
912 children were consented * 233 screen failure * 58 late screen failures * 92 withdrew consent * 58 non-compliant * 15 study group complete * 35 eligible but not enrolled * 4 excluded due to other reasons
Participants by arm
| Arm | Count |
|---|---|
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS Healthy children aged 5-10 years receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 1b: Age 5-10 Years, Placebo Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 2. | 3 |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS Healthy children aged 5-59 months receive a single dose of 5 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 2b: Age 5-59 Months, Placebo Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3 | 3 |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS Healthy children aged 5-10 years receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 2d: Age 5-10 Years, Placebo Healthy children aged 5-10 years receive a single dose placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 3. | 3 |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS Healthy children aged 5-10 years receive a single dose of 20 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 3b: Age 5-10 Years, Placebo Healthy children aged 5-10 years receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4. | 3 |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS Healthy children aged 5-59 months receive a single dose of 10 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 3d: Age 5-59 Months, Placebo Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 4 | 3 |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS Healthy children aged 5-59 months receive a single dose of 20 mg/kg of L9LS one-time via subcutaneous administration.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 4b: Age 5-59 Months, Placebo Healthy children aged 5-59 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously. | 3 |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS Healthy children aged 5-71 months receive a single dose of 30 mg/kg L9LS via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 5b: Age 5-71 Months, Placebo Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration. Once subjects reach day 7 post-administration without safety concerns dosing begins for arm 6. | 3 |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS Healthy children aged 5-71 months receive a single dose of 40 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously. | 9 |
| Age De-escalation and Dose-escalation Study: Arm 6b: Age 5-71 Months, Placebo Healthy children aged 5-71 months receive a single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously. | 3 |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration.
L9LS: Administered subcutaneously.
Placebo: Normal saline administered subcutaneously. | 54 |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS Healthy children aged 5-17 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration.
L9LS: Administered subcutaneously. | 54 |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo Healthy children aged 5-17 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration.
Placebo: Normal saline administered subcutaneously. | 54 |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a single dose of placebo via subcutaneous administration. | 54 |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS Healthy children aged 18-59 months receive a single dose of 10-20 mg/kg L9LS via subcutaneous administration. Six months later, participants receive a second single dose of 10-20 mg/kg L9LS via subcutaneous administration. | 52 |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo Healthy children aged 18-59 months receive a single dose of placebo via subcutaneous administration. Six months later, participants receive a second single dose of placebo via subcutaneous administration. | 56 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 | FG008 | FG009 | FG010 | FG011 | FG012 | FG013 | FG014 | FG015 | FG016 | FG017 | FG018 | FG019 | FG020 | FG021 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Part 1A: Period 2 | Withdrawal by Subject | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Part 1B/Part 2 - Period 1 | Adverse Event | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 1 | 0 | 0 | 0 |
| Part 1B/Part 2 - Period 1 | Lost to Follow-up | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 2 | 3 | 0 | 7 | 2 |
| Part 1B/Part 2 - Period 1 | Missed multiple clinic visits | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 1 | 3 | 1 | 3 |
| Part 1B/Part 2 - Period 1 | Physician Decision | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 0 |
| Part 1B/Part 2 - Period 1 | Withdrawal by Subject | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 0 |
Baseline characteristics
| Characteristic | Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Age De-escalation and Dose-escalation Study: Arm 5b: Age 5-71 Months, Placebo | Age De-escalation and Dose-escalation Study: Arm 2d: Age 5-10 Years, Placebo | Age De-escalation and Dose-escalation Study: Arm 2b: Age 5-59 Months, Placebo | Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 3b: Age 5-10 Years, Placebo | Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 1b: Age 5-10 Years, Placebo | Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 4b: Age 5-59 Months, Placebo | Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9LS/10-20 mg/kg of L9LS | Total | Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Age De-escalation and Dose-escalation Study: Arm 6b: Age 5-71 Months, Placebo | Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Age De-escalation and Dose-escalation Study: Arm 3d: Age 5-59 Months, Placebo |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized 5-120 months | 9 Participants | 9 Participants | 54 Participants | 3 Participants | 3 Participants | 3 Participants | 9 Participants | 9 Participants | 3 Participants | 9 Participants | 54 Participants | 52 Participants | 3 Participants | 9 Participants | 3 Participants | 54 Participants | 54 Participants | 420 Participants | 9 Participants | 3 Participants | 9 Participants | 56 Participants | 3 Participants |
| Race/Ethnicity, Customized Black / Non-Hispanic | 9 Participants | 9 Participants | 54 Participants | 3 Participants | 3 Participants | 3 Participants | 9 Participants | 9 Participants | 3 Participants | 9 Participants | 54 Participants | 52 Participants | 3 Participants | 9 Participants | 3 Participants | 54 Participants | 54 Participants | 420 Participants | 9 Participants | 3 Participants | 9 Participants | 56 Participants | 3 Participants |
| Region of Enrollment Kenya | 9 participants | 9 participants | 54 participants | 3 participants | 3 participants | 3 participants | 9 participants | 9 participants | 3 participants | 9 participants | 54 participants | 52 participants | 3 participants | 9 participants | 3 participants | 54 participants | 54 participants | 420 participants | 9 participants | 3 participants | 9 participants | 56 participants | 3 participants |
| Sex: Female, Male Female | 6 Participants | 5 Participants | 27 Participants | 1 Participants | 1 Participants | 0 Participants | 3 Participants | 6 Participants | 1 Participants | 4 Participants | 28 Participants | 27 Participants | 3 Participants | 1 Participants | 2 Participants | 29 Participants | 34 Participants | 222 Participants | 6 Participants | 1 Participants | 7 Participants | 27 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 4 Participants | 27 Participants | 2 Participants | 2 Participants | 3 Participants | 6 Participants | 3 Participants | 2 Participants | 5 Participants | 26 Participants | 25 Participants | 0 Participants | 8 Participants | 1 Participants | 25 Participants | 20 Participants | 198 Participants | 3 Participants | 2 Participants | 2 Participants | 29 Participants | 0 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 | EG008 affected / at risk | EG009 affected / at risk | EG010 affected / at risk | EG011 affected / at risk | EG012 affected / at risk | EG013 affected / at risk | EG014 affected / at risk | EG015 affected / at risk | EG016 affected / at risk |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 1 / 6 | 0 / 54 | 0 / 54 | 0 / 54 | 0 / 54 | 0 / 52 | 0 / 56 |
| other Total, other adverse events | 8 / 9 | 9 / 9 | 9 / 9 | 8 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 9 / 9 | 8 / 9 | 9 / 9 | 6 / 6 | 54 / 54 | 53 / 54 | 53 / 54 | 53 / 54 | 49 / 52 | 55 / 56 |
| serious Total, serious adverse events | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 9 | 0 / 6 | 5 / 54 | 4 / 54 | 9 / 54 | 2 / 54 | 0 / 52 | 6 / 56 |
Outcome results
Primary
Number of Participants With Local Adverse Events (AEs)
Number of participants with at least one solicited local adverse events occurring within seven days of administration of intervention. Local reactogenicity included injection site pain, tenderness, bruising, swelling, redness, induration, pruritus, and other (e.g. injection site reaction). Adverse events were captured by Investigator examination and history from participants.
Time frame: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)
Population: Modified intent to treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 2 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 2 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 2 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 3 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 1 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 2 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 1 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 1 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pain | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site redness | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site induration | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site swelling | 1 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site pruritus | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site reaction | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) | Injection site bruising | 0 Participants |
Primary
Number of Participants With Local Adverse Events (AEs) (by Grade)
The severity of local AEs was graded using the Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Clinical Trials Grade 1: Pain = does not interfere with activity; Tenderness = mild discomfort to touch; Erythema/Redness = 2.5-5 cm; Induration/Swelling = 2.5-5 cm and does not interfere with activity. Grade 2: Pain = Repeated use of non-narcotic pain reliever \> 24 hours or interferes with daily activity; Tenderness= Discomfort with movement; Erythema/Redness = 5.1-10 cm; Induration/Swelling = 5.1-10 cm and interferes with activity. Grade 3: Pain = Any use of narcotic pain reliever or prevents daily activity; Tenderness = Significant discomfort at rest; Erythema/Redness = \> 10 cm; Induration/Swelling = \> 10 cm or prevents daily activity. Grade 4: Pain = Emergency room (ER) visit or hospitalization; Tenderness = ER visit or hospitalization; Erythema/Redness = Necrosis or exfoliative dermatitis; induration/Swelling = Necrosis Grade 5: Death
Time frame: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)
Population: Modified intent to treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 2 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 2 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 2 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 4 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 1 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 4 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Local Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
Primary
Number of Participants With Systemic Adverse Events (AEs)
Number of participants with local adverse events occurring within seven days of administration of intervention. Systemic reactogenicity events included pyrexia (fever), malaise (feeling unusually tired or unwell), muscle aches, headache, chills, nausea, and joint pain. Adverse events were captured by Investigator examination and history from participants.
Time frame: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)
Population: Modified intent to treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 3 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 1 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 1 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 3 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 1 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 5 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 1 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 6 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 1 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 4 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 4 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 3 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 12 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 6 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 13 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Headache | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Nausea | 5 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Chills | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Joint pain | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Pyrexia | 7 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Malaise | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) | Muscle aches | 0 Participants |
Primary
Number of Participants With Systemic Adverse Events (AEs) (by Grade)
The severity of systemic adverse events occurring after the administration of L9LS was assessed using the grading scale below: Grade 1: Fever = 37.5\^oC-37.9\^oC; Fatigue, Headache, Myalgia = No interference with activity; Nausea = no interference with activity or 1-2 episodes/hour Grade 2: Fever = 38\^oC-38.4\^oC; Fatigue, Myalgia = Some interference with activity; Headache = Repeated use of non-narcotic pain reliever \> 24 hours or some interference with activity; Nausea = Some interference with activity or \> 2 episodes/24 hours Grade 3: Fever = 38.5\^oC-39.5\^oC; Fatigue = Prevents daily activity; Headache =Significant; any use of narcotic pain reliever or prevents daily activity; Myalgia =Significant; prevents daily activity; Nausea = Prevents daily activity, requires outpatient intravenous hydration Grade 4: Fever = \> 39.5\^oC; Fatigue, Headache, Myalgia = Emergency room (ER) visit or hospitalization; Nausea = ER visit or hospitalization for hypotensive shock Grade 5: Death
Time frame: Age De-escalation and Dose escalation: within 7 days of administration of intervention; Efficacy study: within 7 days after first intervention, and 7 days after second intervention (second intervention occurred 6 months post first intervention)
Population: Modified intent to treat population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 1a: Age 5-10 Years, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2a: Age 5-59 Months, 5 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 2c: Age 5-10 Years, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 3 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3a: Age 5-10 Years, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-10 Years, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 3c: Age 5-59 Months, 10 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 4a: Age 5-59 Months, 20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 2 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-59 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 5a: Age 5-71 Months, 30 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 1 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Arm 6a: Age 5-71 Months, 40 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Age De-escalation and Dose-escalation Study: Age 5-71 Months, Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 10 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 3 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1a: Age 5-17 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 2 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 11 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 1b: Age 5-17 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 4 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 3 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 7 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 1c: Age 5-17 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 3 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2a: Age 18-59 Months, 10-20 mg/kg of L9LS/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 6 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 3 Participants |
| Efficacy Study: Arm 2b: Age 18-59 Months, 10-20 mg/kg of L9L/10-20 mg/kg of L9LS | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 4 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 1 | 5 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 5 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 4 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 3 | 0 Participants |
| Efficacy Study: Arm 2c: Age 18-59 Months, Placebo/Placebo | Number of Participants With Systemic Adverse Events (AEs) (by Grade) | Grade 2 | 3 Participants |