Trial Outcomes & Findings for L-PZQ ODT in Schistosoma Infected Children (NCT NCT03845140)

Results Overview

Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

288 participants

Primary outcome timeframe

at Week 3

Results posted on

2024-03-21

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Overall Study STARTED	100	50	30	18	30	60
Overall Study COMPLETED	100	49	30	18	30	60
Overall Study NOT COMPLETED	0	1	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Overall Study Participant travelled outside study area	0	1	0	0	0	0

Baseline Characteristics

L-PZQ ODT in Schistosoma Infected Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.	Total n=288 Participants Total of all reporting groups
Age, Continuous	5.4 years STANDARD_DEVIATION 0.69 • n=5 Participants	5.5 years STANDARD_DEVIATION 0.83 • n=7 Participants	3.0 years STANDARD_DEVIATION 0.59 • n=5 Participants	1.4 years STANDARD_DEVIATION 0.43 • n=4 Participants	4.6 years STANDARD_DEVIATION 1.49 • n=21 Participants	5.1 years STANDARD_DEVIATION 1.51 • n=8 Participants	4.8 years STANDARD_DEVIATION 1.54 • n=8 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	21 Participants n=7 Participants	16 Participants n=5 Participants	11 Participants n=4 Participants	9 Participants n=21 Participants	28 Participants n=8 Participants	137 Participants n=8 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	29 Participants n=7 Participants	14 Participants n=5 Participants	7 Participants n=4 Participants	21 Participants n=21 Participants	32 Participants n=8 Participants	151 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	100 Participants n=5 Participants	50 Participants n=7 Participants	30 Participants n=5 Participants	18 Participants n=4 Participants	30 Participants n=21 Participants	60 Participants n=8 Participants	288 Participants n=8 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants

PRIMARY outcome

Timeframe: at Week 3

Population: Modified intent to treat analysis population (mITT) included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Only 1 participant from Cohort 1b was lost to follow-up and was imputed as non-cured.

Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=98 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=48 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 1a and Cohort 1b: Number of Participants With Clinical Cure Determined by Kato-Katz Method	86 Participants	39 Participants	—	—	—	—

SECONDARY outcome

Timeframe: at Week 3

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Clinical cure was defined as no parasite egg in the stool at Week 3 as determined by the Kato-Katz method. Number of participants with clinical cure were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=29 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=18 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 2 and Cohort 3: Number of Participants With Clinical Cure Determined by Kato-Katz Method	27 Participants	17 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Week 3 and Week 5

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.

Clinical cure was defined as no parasite egg in the urine samples at follow up as determined by the urine filtration technique. Number of participants with clinical cure were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=29 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=58 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique Week 3	17 Participants	50 Participants	—	—	—	—
Cohort 4a and Cohort 4b: Number of Participants With Clinical Cure Determined by Urine Filtration Technique Week 5	—	55 Participants	—	—	—	—

SECONDARY outcome

Timeframe: Pre-treatment, Week 3 post-treatment

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the Kato-Katz method.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=98 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=48 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=29 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 1a, Cohort 1b, Cohort 2 and Cohort 3: Egg Reduction Rate (Percent [%]) Determined by Kato-Katz Method	99.5 percent reduction in egg count Interval 98.8 to 99.9	99.2 percent reduction in egg count Interval 97.6 to 99.8	88.5 percent reduction in egg count Interval 56.4 to 100.0	95.6 percent reduction in egg count Interval 77.0 to 100.0	—	—

SECONDARY outcome

Timeframe: Pre-treatment, Weeks 3 and 5 post-treatment

Population: mITT included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment. Here "Number Analyzed" signifies those participants who were evaluated at the specified time point.

Percentage of reduction in group mean egg count was calculated as relative difference between the post-treatment arithmetic mean egg count and pre-treatment arithmetic mean egg count at baseline count, (pre-treatment mean egg count minus post-treatment mean egg count divided by pre-treatment mean egg count) \*100. Egg counts were determined by the urine filtration technique.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=29 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=58 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique Week 3	99.4 percent reduction in egg count Interval 98.8 to 99.8	99.2 percent reduction in egg count Interval 98.2 to 99.8	—	—	—	—
Cohort 4a and Cohort 4b: Egg Reduction Rate (Percent [%]) Determined by Urine Filtration Technique Week 5	—	99.3 percent reduction in egg count Interval 97.6 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: at Week 3

Population: mITT analysis population included all enrolled participants who received one dose of treatment and had baseline measurement, excluding those who used anti-malaria treatment after enrollment.

Clinical cure is defined as absence of test line in the POC-CCA test cassette (that is no Schistosoma antigens detected). Number of participants with clinical cure were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=98 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=48 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=29 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 1a, Cohort 1b, Cohort 2, and Cohort 3: Number of Participants With Clinical Cure Determined by Point-of-Care Circulating Cathodic Antigen (POC-CCA) Test	63 Participants	26 Participants	18 Participants	13 Participants	—	—

SECONDARY outcome

Timeframe: up to Day 40

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Adverse Event (AE) was defined any untoward medical occurrence in a participant administered with a study drug, which does not necessarily had a causal relationship with this treatment. Serious AE was defined AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial/prolonged inpatient hospitalization; congenital anomaly/birth defect. TEAEs: TEAEs were defined as those events with onset dates/time occurring after study intervention administration or events that worsen after study intervention administration. TEAEs included serious TEAEs and non-serious TEAEs. Treatment-related TEAEs: reasonably related to the study intervention.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs Participants with TEAEs	66 Participants	31 Participants	20 Participants	14 Participants	9 Participants	28 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs Participants with serious TEAEs	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-Related TEAEs Participants with treatment-related TEAEs	31 Participants	14 Participants	16 Participants	4 Participants	0 Participants	5 Participants

SECONDARY outcome

Timeframe: up to Day 40

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Severity of TEAEs were graded using Qualitative Toxicity Scale, as follows: Mild: Participant is aware of the event or symptom, but the event or symptom is easily tolerated; Moderate: Participant experiences sufficient discomfort to interfere with or reduce his or her usual level of activity; Severe: Significant impairment of functioning: the participant is unable to carry out his or her usual activities. Number of participants with TEAEs by severity were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale Mild	57 Participants	27 Participants	19 Participants	14 Participants	5 Participants	21 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale Moderate	21 Participants	8 Participants	9 Participants	2 Participants	4 Participants	12 Participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) by Severity According to Qualitative Toxicity Scale Severe	1 Participants	1 Participants	1 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular hemoglobin. Change from baseline in hematology parameter: erythrocytes mean corpuscular hemoglobin at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin	-0.12 picogram Standard Deviation 1.273	0.20 picogram Standard Deviation 0.665	0.18 picogram Standard Deviation 0.348	0.34 picogram Standard Deviation 0.699	0.02 picogram Standard Deviation 0.325	0.30 picogram Standard Deviation 1.046

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin. Change from baseline in hematology parameters: erythrocytes mean corpuscular HGB concentration and hemoglobin at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin Erythrocytes Mean Corpuscular HGB Concentration	-0.6 gram per liter (g/L) Standard Deviation 10.95	3.1 gram per liter (g/L) Standard Deviation 9.97	5.2 gram per liter (g/L) Standard Deviation 13.85	3.9 gram per liter (g/L) Standard Deviation 11.25	4.5 gram per liter (g/L) Standard Deviation 6.52	1.0 gram per liter (g/L) Standard Deviation 11.82
Change From Baseline in Hematology Parameters: Erythrocytes Mean Corpuscular Hemoglobin (HGB) Concentration and Hemoglobin Hemoglobin	-0.8 gram per liter (g/L) Standard Deviation 8.26	-0.0 gram per liter (g/L) Standard Deviation 11.56	-4.4 gram per liter (g/L) Standard Deviation 10.29	1.1 gram per liter (g/L) Standard Deviation 7.22	-0.1 gram per liter (g/L) Standard Deviation 6.89	0.8 gram per liter (g/L) Standard Deviation 7.43

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes mean corpuscular volume. Change from baseline in hematology parameter: erythrocytes mean corpuscular volume at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume	-0.24 femtoliters Standard Deviation 2.657	-0.04 femtoliters Standard Deviation 1.247	-0.06 femtoliters Standard Deviation 0.905	0.16 femtoliters Standard Deviation 2.101	-0.88 femtoliters Standard Deviation 0.948	0.61 femtoliters Standard Deviation 1.381

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameter: erythrocytes. Change from baseline in hematology parameter: erythrocytes at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameter: Erythrocytes	-0.003 10^12 cells per liter Standard Deviation 0.3245	-0.061 10^12 cells per liter Standard Deviation 0.3792	-0.240 10^12 cells per liter Standard Deviation 0.5650	-0.044 10^12 cells per liter Standard Deviation 0.3724	0.001 10^12 cells per liter Standard Deviation 0.2921	-0.028 10^12 cells per liter Standard Deviation 0.4000

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes. Change from baseline in hematology parameters: hematocrit, lymphocytes/leukocytes, mixed cells/leukocytes, neutrophils/leukocytes at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes Hematocrit	0.075 percentage of cells Standard Deviation 3.3856	-0.434 percentage of cells Standard Deviation 3.0010	-1.787 percentage of cells Standard Deviation 3.9566	-0.144 percentage of cells Standard Deviation 2.6203	-0.400 percentage of cells Standard Deviation 2.3799	0.103 percentage of cells Standard Deviation 3.0415
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes Lymphocytes/Leukocytes	4.35 percentage of cells Standard Deviation 10.617	1.69 percentage of cells Standard Deviation 9.171	0.44 percentage of cells Standard Deviation 10.390	6.13 percentage of cells Standard Deviation 7.579	3.75 percentage of cells Standard Deviation 7.973	5.82 percentage of cells Standard Deviation 8.456
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes Mixed Cells/Leukocytes	-1.35 percentage of cells Standard Deviation 6.526	0.45 percentage of cells Standard Deviation 7.579	0.07 percentage of cells Standard Deviation 4.816	0.19 percentage of cells Standard Deviation 4.597	1.87 percentage of cells Standard Deviation 4.278	-1.19 percentage of cells Standard Deviation 6.436
Change From Baseline in Hematology Parameters: Hematocrit, Lymphocytes/Leukocytes, Mixed Cells/Leukocytes, Neutrophils/Leukocytes Neutrophils/Leukocytes	-2.01 percentage of cells Standard Deviation 13.738	-3.03 percentage of cells Standard Deviation 13.733	0.15 percentage of cells Standard Deviation 13.430	-6.32 percentage of cells Standard Deviation 8.848	-11.68 percentage of cells Standard Deviation 8.228	-4.60 percentage of cells Standard Deviation 11.336

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the hematology parameters: leukocytes and platelets. Change from baseline in hematology parameters: leukocytes and platelets at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Hematology Parameters: Leukocytes and Platelets Leukocytes	-0.357 10^9 cells per liter Standard Deviation 2.2500	-0.512 10^9 cells per liter Standard Deviation 2.3055	-0.967 10^9 cells per liter Standard Deviation 1.9043	0.317 10^9 cells per liter Standard Deviation 2.1385	-0.390 10^9 cells per liter Standard Deviation 1.9805	0.340 10^9 cells per liter Standard Deviation 1.9324
Change From Baseline in Hematology Parameters: Leukocytes and Platelets Platelets	-21.2 10^9 cells per liter Standard Deviation 56.04	-24.5 10^9 cells per liter Standard Deviation 39.08	-28.6 10^9 cells per liter Standard Deviation 61.75	49.7 10^9 cells per liter Standard Deviation 170.67	-10.0 10^9 cells per liter Standard Deviation 33.12	-14.0 10^9 cells per liter Standard Deviation 62.78

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase. Change from baseline in chemistry parameters: Alanine Aminotransferase and Aspartate Aminotransferase at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase Alanine Aminotransferase	-1.91 units per liter (U/L) Standard Deviation 5.447	-1.23 units per liter (U/L) Standard Deviation 6.245	-2.03 units per liter (U/L) Standard Deviation 3.945	-0.40 units per liter (U/L) Standard Deviation 5.959	-1.27 units per liter (U/L) Standard Deviation 2.532	-1.57 units per liter (U/L) Standard Deviation 3.614
Change From Baseline in Chemistry Parameters: Alanine Aminotransferase and Aspartate Aminotransferase Aspartate Aminotransferase	-2.50 units per liter (U/L) Standard Deviation 9.271	-0.59 units per liter (U/L) Standard Deviation 12.759	-2.55 units per liter (U/L) Standard Deviation 8.910	4.41 units per liter (U/L) Standard Deviation 27.941	-2.87 units per liter (U/L) Standard Deviation 4.805	-1.93 units per liter (U/L) Standard Deviation 4.430

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: bilirubin, creatinine and direct bilirubin. Change from baseline in chemistry parameters: bilirubin, creatinine and direct bilirubin at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin Bilirubin	-1.48 micromole per liter (mcmol/L) Standard Deviation 3.056	-0.22 micromole per liter (mcmol/L) Standard Deviation 2.531	0.25 micromole per liter (mcmol/L) Standard Deviation 3.651	-1.62 micromole per liter (mcmol/L) Standard Deviation 3.075	—	—
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin Creatinine	4.565 micromole per liter (mcmol/L) Standard Deviation 10.7273	6.386 micromole per liter (mcmol/L) Standard Deviation 13.9391	3.340 micromole per liter (mcmol/L) Standard Deviation 16.7903	1.644 micromole per liter (mcmol/L) Standard Deviation 8.2799	9.733 micromole per liter (mcmol/L) Standard Deviation 10.7220	6.967 micromole per liter (mcmol/L) Standard Deviation 13.1561
Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine and Direct Bilirubin Direct Bilirubin	0.09 micromole per liter (mcmol/L) Standard Deviation 0.937	0.06 micromole per liter (mcmol/L) Standard Deviation 0.278	0.05 micromole per liter (mcmol/L) Standard Deviation 0.219	-0.04 micromole per liter (mcmol/L) Standard Deviation 0.144	-0.05 micromole per liter (mcmol/L) Standard Deviation 0.523	0.07 micromole per liter (mcmol/L) Standard Deviation 0.453

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: C reactive protein. Change from baseline in chemistry parameter: C reactive protein at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Chemistry Parameter: C Reactive Protein	0.411 milligram per liter (mg/L) Standard Deviation 9.6546	0.004 milligram per liter (mg/L) Standard Deviation 3.5448	-0.336 milligram per liter (mg/L) Standard Deviation 3.8792	0.872 milligram per liter (mg/L) Standard Deviation 4.6025	-0.588 milligram per liter (mg/L) Standard Deviation 4.2572	0.283 milligram per liter (mg/L) Standard Deviation 3.3653

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameters: glucose, urea and urea nitrogen. Change from baseline in chemistry parameters: glucose, urea and urea nitrogen at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen Glucose	-0.056 millimole per liter (mmol/L) Standard Deviation 1.2426	0.277 millimole per liter (mmol/L) Standard Deviation 1.3265	0.207 millimole per liter (mmol/L) Standard Deviation 1.2011	-0.354 millimole per liter (mmol/L) Standard Deviation 1.4042	-0.070 millimole per liter (mmol/L) Standard Deviation 1.0867	-0.052 millimole per liter (mmol/L) Standard Deviation 1.4386
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen Urea	0.061 millimole per liter (mmol/L) Standard Deviation 0.1159	0.087 millimole per liter (mmol/L) Standard Deviation 0.0691	0.082 millimole per liter (mmol/L) Standard Deviation 0.0611	0.043 millimole per liter (mmol/L) Standard Deviation 0.0528	—	—
Change From Baseline in Chemistry Parameters: Glucose, Urea and Urea Nitrogen Urea Nitrogen	1.443 millimole per liter (mmol/L) Standard Deviation 1.2279	1.257 millimole per liter (mmol/L) Standard Deviation 1.1638	2.017 millimole per liter (mmol/L) Standard Deviation 1.7597	0.614 millimole per liter (mmol/L) Standard Deviation 0.9841	1.966 millimole per liter (mmol/L) Standard Deviation 1.2305	2.432 millimole per liter (mmol/L) Standard Deviation 1.3376

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Blood samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the chemistry parameter: total Protein. Change from baseline in chemistry parameter: total Protein at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Chemistry Parameter: Total Protein	-5.20 gram per liter (g/L) Standard Deviation 5.001	-6.32 gram per liter (g/L) Standard Deviation 5.018	-6.22 gram per liter (g/L) Standard Deviation 7.241	0.16 gram per liter (g/L) Standard Deviation 4.918	-3.40 gram per liter (g/L) Standard Deviation 5.308	-3.18 gram per liter (g/L) Standard Deviation 4.959

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameters: specific gravity. Change from baseline in urinalyses parameter: specific gravity Day 1 was reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Urinalyses Parameter: Specific Gravity of Urine	0.0066 ratio Standard Deviation 0.00797	0.0064 ratio Standard Deviation 0.00722	0.0060 ratio Standard Deviation 0.00781	0.0039 ratio Standard Deviation 0.00932	0.0047 ratio Standard Deviation 0.00787	0.0091 ratio Standard Deviation 0.00704

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: pH. Change from baseline in urinalyses parameter: pH at Day 1 was reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Urinalyses Parameter: Potential of Hydrogen (pH) of Urine	-0.33 pH Standard Deviation 1.176	-0.54 pH Standard Deviation 1.068	-0.50 pH Standard Deviation 1.017	-0.11 pH Standard Deviation 0.654	-0.42 pH Standard Deviation 0.872	-0.43 pH Standard Deviation 0.899

SECONDARY outcome

Timeframe: Baseline, Day 1

Population: SAF included all participants who received 1 dose of study treatment.

Urine samples were collected in a fasted condition (after a fast of at least 12 hours) to analyze the urinalyses parameter: urobilinogen. Change from baseline in urinalyses parameter: urobilinogen at Day 1 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Urinalyses Parameter: Urobilinogen	0.01 mcmol/L Standard Deviation 4.069	0.19 mcmol/L Standard Deviation 4.387	0.48 mcmol/L Standard Deviation 2.355	0.00 mcmol/L Standard Deviation 0.000	-0.03 mcmol/L Standard Deviation 0.146	0.01 mcmol/L Standard Deviation 0.090

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Diastolic blood pressure and systolic blood pressure were measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital signs: diastolic blood pressure and systolic blood pressure at Week 3 were reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure Diastolic Blood Pressure	2.7 millimeters of mercury (mmHg) Standard Deviation 10.92	2.0 millimeters of mercury (mmHg) Standard Deviation 9.49	2.9 millimeters of mercury (mmHg) Standard Deviation 10.58	-1.3 millimeters of mercury (mmHg) Standard Deviation 10.27	1.2 millimeters of mercury (mmHg) Standard Deviation 12.49	4.1 millimeters of mercury (mmHg) Standard Deviation 11.73
Change From Baseline in Vital Signs: Diastolic Blood Pressure and Systolic Blood Pressure Systolic Blood Pressure	-0.5 millimeters of mercury (mmHg) Standard Deviation 12.37	-1.4 millimeters of mercury (mmHg) Standard Deviation 12.17	0.3 millimeters of mercury (mmHg) Standard Deviation 12.58	0.8 millimeters of mercury (mmHg) Standard Deviation 8.06	-1.8 millimeters of mercury (mmHg) Standard Deviation 9.78	3.7 millimeters of mercury (mmHg) Standard Deviation 12.07

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Pulse rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: pulse rate at Week 3 was reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Vital Signs: Pulse Rate	-1.8 beats per minute Standard Deviation 14.65	-2.6 beats per minute Standard Deviation 11.90	-4.1 beats per minute Standard Deviation 20.46	-9.6 beats per minute Standard Deviation 20.74	-3.7 beats per minute Standard Deviation 18.78	-1.7 beats per minute Standard Deviation 11.90

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Respiratory rate was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: respiratory rate at Week 3 was reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Vital Sign: Respiratory Rate	0.5 breaths per minute Standard Deviation 4.09	-0.1 breaths per minute Standard Deviation 3.63	-1.0 breaths per minute Standard Deviation 2.98	-3.4 breaths per minute Standard Deviation 8.91	-2.6 breaths per minute Standard Deviation 3.85	-0.9 breaths per minute Standard Deviation 4.02

SECONDARY outcome

Timeframe: Baseline, Week 3

Population: SAF included all participants who received 1 dose of study treatment.

Temperature was measured after at least 5 minutes of rest for the participant in a quiet sitting without distractions. Change from baseline in vital sign: temperature at Week 3 was reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Change From Baseline in Vital Signs: Temperature	-0.02 degree Celsius Standard Deviation 0.482	-0.04 degree Celsius Standard Deviation 0.529	0.21 degree Celsius Standard Deviation 0.734	-0.10 degree Celsius Standard Deviation 0.484	-0.01 degree Celsius Standard Deviation 0.529	0.08 degree Celsius Standard Deviation 0.427

SECONDARY outcome

Timeframe: Day 1

Population: SAF anlysis population included all participants who received 1 dose of study treatment.

Reaction to study intervention administration were recorded to describe tolerability as assessed by nurse/site staff for all children enrolled in the study. Reactions categorized as spitting, crying, diarrheas, sleepiness, abdominal pain, fever, vomiting and other. Number of participants with reaction to study intervention administration reported.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Number of Participants With Reaction to Study Intervention Administration Crying	1 Participants	4 Participants	8 Participants	8 Participants	2 Participants	2 Participants
Number of Participants With Reaction to Study Intervention Administration Spitting	1 Participants	3 Participants	6 Participants	6 Participants	0 Participants	3 Participants
Number of Participants With Reaction to Study Intervention Administration Diarrhoea	16 Participants	3 Participants	4 Participants	2 Participants	0 Participants	2 Participants
Number of Participants With Reaction to Study Intervention Administration Sleepiness	7 Participants	3 Participants	7 Participants	2 Participants	0 Participants	1 Participants
Number of Participants With Reaction to Study Intervention Administration Abdominal pain	21 Participants	9 Participants	9 Participants	0 Participants	0 Participants	2 Participants
Number of Participants With Reaction to Study Intervention Administration Fever	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With Reaction to Study Intervention Administration Vomiting	7 Participants	4 Participants	4 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Reaction to Study Intervention Administration Other	3 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Day 1

Population: SAF included all participants who received 1 dose of study treatment. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure.

Palatability of the study intervention was assessed using a human gustatory sensation test (100-millimeter \[mm\] visual analog scale \[VAS\]) incorporating a facial hedonic scale, where lower score (0) indicates "not acceptable/not liked at all" and higher score (100) indicates "very acceptable/liked very much".

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=73 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=34 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=13 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=35 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Cohort 1a, Cohort 1b, Cohort 4a and Cohort 4b: Palatability Assessment Based on Visual Analog Scale (VAS) Score	84.0 score on a scale Interval 54.0 to 91.0	50.0 score on a scale Interval 26.0 to 87.0	88.0 score on a scale Interval 69.0 to 91.0	88.0 score on a scale Interval 79.0 to 92.0	—	—

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: The Pharmacokinetic Analysis Population (PKP) is a subset of the SAF population and consisted of all participants who received at least one dose of active Investigational Medicinal Product (IMP) and provide at least one measurable post-dose concentration.

Cmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=17 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=10 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=9 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=2 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=14 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=15 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ R-PZO	347 nanogram per milliliter (ng/mL) Standard Deviation 281.4	59.3 nanogram per milliliter (ng/mL) Standard Deviation 60.39	1470 nanogram per milliliter (ng/mL) Standard Deviation 1326	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.	523 nanogram per milliliter (ng/mL) Standard Deviation 667.7	300 nanogram per milliliter (ng/mL) Standard Deviation 239.7
Maximum Observed Plasma Concentration (Cmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ S-PZO	1.27 nanogram per milliliter (ng/mL) Standard Deviation 2.834	343 nanogram per milliliter (ng/mL) Standard Deviation 298.9	0.00 nanogram per milliliter (ng/mL) Standard Deviation 0.000	NA nanogram per milliliter (ng/mL) Standard Deviation NA Mean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.	0.00 nanogram per milliliter (ng/mL) Standard Deviation 0.000	0.360 nanogram per milliliter (ng/mL) Standard Deviation 1.394

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: PKP analysis population is a subset of the SAF population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration.

Tmax was obtained directly from the plasma concentration versus time curve.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=17 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=10 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=9 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=2 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=14 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=15 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ R-PZO	02.00 hours Interval 0.5 to 8.0	01.00 hours Interval 0.0 to 12.0	03.00 hours Interval 1.0 to 12.0	NA hours Median and Full range was not calculated for participants fewer than 3 as per planned analysis.	1.50 hours Interval 0.5 to 6.02	03.00 hours Interval 0.5 to 8.02
Time to Reach Maximum Plasma Concentration (Tmax) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ S-PZO	0.00 hours Interval 0.0 to 4.0	2.49 hours Interval 0.5 to 12.0	0.00 hours Interval 0.0 to 8.0	NA hours Median and Full range was not calculated for participants fewer than 3 as per planned analysis.	0.00 hours Interval 0.0 to 5.0	0.00 hours Interval 0.0 to 5.0

SECONDARY outcome

Timeframe: Pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 12 hours post-dose

Population: PKP analysis population is a subset of the SAF population and consisted of all participants who received at least one dose of active IMP and provide at least one measurable post-dose concentration. Here "Number Analyzed" signifies those participants who were evaluated in specified categories.

Area under the plasma concentration versus time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLOQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

Outcome measures

Outcome measures
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=17 Participants Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=10 Participants Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=9 Participants Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=2 Participants Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=14 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=15 Participants Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ R-PZO	1080 hoursnanogram per milliliter (hng/mL) Standard Deviation 1036	184 hoursnanogram per milliliter (hng/mL) Standard Deviation 150.0	2720 hoursnanogram per milliliter (hng/mL) Standard Deviation 1718	NA hoursnanogram per milliliter (hng/mL) Standard Deviation NA Mean and standard deviation was not calculated for participants fewer than 3 as per planned analysis.	1190 hoursnanogram per milliliter (hng/mL) Standard Deviation 1110	907 hoursnanogram per milliliter (hng/mL) Standard Deviation 776.3
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Measurable Concentration (AUC0-t) of Praziquantel (PZQ) Enantiomers: R-PZQ and S-PZQ S-PZO	2.84 hoursnanogram per milliliter (hng/mL) Standard Deviation 0.9072	1240 hoursnanogram per milliliter (hng/mL) Standard Deviation 1124	—	—	—	—

Adverse Events

Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg

Serious events: 0 serious events

Other events: 66 other events

Deaths: 0 deaths

Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg

Serious events: 0 serious events

Other events: 31 other events

Deaths: 0 deaths

Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg

Serious events: 1 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 participants at risk Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 participants at risk Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 participants at risk Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 participants at risk Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 participants at risk Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 participants at risk Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Infections and infestations Malaria	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	1.7% 1/60 • up to Day 40

Other adverse events

Other adverse events
Measure	Cohort 1a: 4 to 6 Years L-PZQ ODT 50 mg/kg n=100 participants at risk Participants aged 4 to 6 years infected with Schistosoma (S.) mansoni received Levorotatory enantiomer of praziquantel (L-PZQ) orodispersible tablets (ODT) (150 milligrams \[mg\]) orally at a dose of 50 milligram per kilogram (mg/Kg) as a single oral dose after food-intake on Day 1.	Cohort 1b: 4 to 6 Years Biltricide® 40 mg/kg n=50 participants at risk Participants aged 4 to 6 years infected with S. mansoni received Racemate Praziquantel tablets (Biltricide®) (600 mg) orally at a dose of 40 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 2: 2 to 3 Years L-PZQ ODT 50 mg/kg n=30 participants at risk Participants aged 2 to 3 years infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 3: 3 to 24 Months L-PZQ ODT 50 mg/kg n=18 participants at risk Participants aged 3 to 24 months infected with S. mansoni received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4a: 3 Months to 6 Years L-PZQ ODT 50 mg/kg n=30 participants at risk Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 50 mg/kg as a single oral dose after food-intake on Day 1.	Cohort 4b: 3 Months to 6 Years L-PZQ ODT 60 mg/kg n=60 participants at risk Participants aged 3 months to 6 years infected with S. haematobium received L-PZQ ODT (150 mg) tablet orally at a dose of 60 mg/kg as a single oral dose after food-intake on Day 1.
Gastrointestinal disorders Abdominal pain	23.0% 23/100 • up to Day 40	20.0% 10/50 • up to Day 40	30.0% 9/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	3.3% 2/60 • up to Day 40
Gastrointestinal disorders Diarrhoea	18.0% 18/100 • up to Day 40	6.0% 3/50 • up to Day 40	13.3% 4/30 • up to Day 40	11.1% 2/18 • up to Day 40	0.00% 0/30 • up to Day 40	3.3% 2/60 • up to Day 40
Gastrointestinal disorders Vomiting	8.0% 8/100 • up to Day 40	10.0% 5/50 • up to Day 40	13.3% 4/30 • up to Day 40	5.6% 1/18 • up to Day 40	3.3% 1/30 • up to Day 40	0.00% 0/60 • up to Day 40
Nervous system disorders Somnolence	8.0% 8/100 • up to Day 40	6.0% 3/50 • up to Day 40	26.7% 8/30 • up to Day 40	11.1% 2/18 • up to Day 40	0.00% 0/30 • up to Day 40	1.7% 1/60 • up to Day 40
Infections and infestations Acarodermatitis	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Bronchitis	8.0% 8/100 • up to Day 40	8.0% 4/50 • up to Day 40	3.3% 1/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Conjunctivitis	0.00% 0/100 • up to Day 40	2.0% 1/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Diarrhoea infectious	1.0% 1/100 • up to Day 40	2.0% 1/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Escherichia infection	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Gastroenteritis	3.0% 3/100 • up to Day 40	2.0% 1/50 • up to Day 40	3.3% 1/30 • up to Day 40	16.7% 3/18 • up to Day 40	0.00% 0/30 • up to Day 40	5.0% 3/60 • up to Day 40
Infections and infestations Malaria	2.0% 2/100 • up to Day 40	4.0% 2/50 • up to Day 40	6.7% 2/30 • up to Day 40	0.00% 0/18 • up to Day 40	3.3% 1/30 • up to Day 40	5.0% 3/60 • up to Day 40
Infections and infestations Nasopharyngitis	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	6.7% 2/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	3.3% 2/60 • up to Day 40
Infections and infestations Rhinitis	5.0% 5/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/18 • up to Day 40	3.3% 1/30 • up to Day 40	0.00% 0/60 • up to Day 40
Infections and infestations Tinea capitis	3.0% 3/100 • up to Day 40	6.0% 3/50 • up to Day 40	6.7% 2/30 • up to Day 40	5.6% 1/18 • up to Day 40	10.0% 3/30 • up to Day 40	1.7% 1/60 • up to Day 40
Infections and infestations Upper respiratory tract infection	4.0% 4/100 • up to Day 40	2.0% 1/50 • up to Day 40	10.0% 3/30 • up to Day 40	5.6% 1/18 • up to Day 40	16.7% 5/30 • up to Day 40	5.0% 3/60 • up to Day 40
Blood and lymphatic system disorders Hypochromic anaemia	1.0% 1/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Blood and lymphatic system disorders Lymphocytosis	6.0% 6/100 • up to Day 40	2.0% 1/50 • up to Day 40	3.3% 1/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	6.7% 4/60 • up to Day 40
Blood and lymphatic system disorders Neutropenia	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	3.3% 1/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	8.3% 5/60 • up to Day 40
Blood and lymphatic system disorders Thrombocytosis	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
General disorders Feeling hot	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
General disorders Pyrexia	2.0% 2/100 • up to Day 40	2.0% 1/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	1.7% 1/60 • up to Day 40
Investigations Transaminases increased	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Renal and urinary disorders Ketonuria	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	6.7% 2/30 • up to Day 40	0.00% 0/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Renal and urinary disorders Leukocyturia	1.0% 1/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	0.00% 0/60 • up to Day 40
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	1.0% 1/100 • up to Day 40	2.0% 1/50 • up to Day 40	0.00% 0/30 • up to Day 40	16.7% 3/18 • up to Day 40	3.3% 1/30 • up to Day 40	6.7% 4/60 • up to Day 40
Skin and subcutaneous tissue disorders Dermatitis allergic	0.00% 0/100 • up to Day 40	0.00% 0/50 • up to Day 40	0.00% 0/30 • up to Day 40	5.6% 1/18 • up to Day 40	0.00% 0/30 • up to Day 40	3.3% 2/60 • up to Day 40
Infections and infestations Urinary tract infection	2.0% 2/100 • up to Day 40	4.0% 2/50 • up to Day 40	0.00% 0/30 • up to Day 40	16.7% 3/18 • up to Day 40	0.00% 0/30 • up to Day 40	1.7% 1/60 • up to Day 40

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER