Trial Outcomes & Findings for Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa (NCT NCT00677833)

Last Updated: 2014-06-26

Results Overview

ACPR (PCR-corrected) was defined as asexual Plasmodium falciparum (P.falciparum) parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of Early Treatment Failure (ETF) (see measure description in secondary outcome measures 7 and 8) or PCR-corrected Late Treatment Failure (LTF) (which includes PCR-corrected Late Clinical Failures \[LCF\] - see measure description in secondary outcome measure 9 and 10, and PCR-corrected Late Parasitologic Failures (LPF)- see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

361 participants

Primary outcome timeframe

Day 28

Results posted on

2014-06-26

Participant Flow

Participants were recruited in 2 age-based Cohorts. Cohort 1=participants between 5-12 years of age, assumed to have some degree of immunity and at less risk for untoward outcome. After demonstration of successful treatment, safety and tolerability in Cohort 1, participants between \>=6 months of age to \<=59 months of age were enrolled in Cohort 2.

Participants were enrolled in 2 cohorts based on different age criteria. All participants in Cohort 1 met the age criteria where as 3 participants enrolled in Cohort 2 were slightly older than 5 years (by less than 2 months).

Participant milestones

Participant milestones
Measure	Cohort 1: Azithromycin + Chloroquine Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (\>=) 5 years of age and less than or equal to (\<=) 12 years of age.	Cohort 1: Artemether + Lumefantrine Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 2: Azithromycin + Chloroquine Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Overall Study STARTED	55	51	124	131
Overall Study COMPLETED	51	51	122	128
Overall Study NOT COMPLETED	4	0	2	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1: Azithromycin + Chloroquine Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between greater than or equal to (\>=) 5 years of age and less than or equal to (\<=) 12 years of age.	Cohort 1: Artemether + Lumefantrine Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 2: Azithromycin + Chloroquine Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Overall Study Withdrawal by Subject	4	0	1	3
Overall Study Lost to Follow-up	0	0	1	0

Baseline Characteristics

Azithromycin Plus Chloroquine Versus Artemether-Lumefantrine For The Treatment Of Uncomplicated P. Falciparum Malaria In Children In Africa

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort 1: Azithromycin + Chloroquine n=55 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 1: Artemether + Lumefantrine n=51 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 2: Azithromycin + Chloroquine n=124 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Total n=361 Participants Total of all reporting groups
Age, Customized 6 months - less than 5 years	0 Participants n=5 Participants	0 Participants n=7 Participants	123 Participants n=5 Participants	129 Participants n=4 Participants	252 Participants n=21 Participants
Age, Customized 5 years - 12 years	55 Participants n=5 Participants	51 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	109 Participants n=21 Participants
Sex: Female, Male Female	28 Participants n=5 Participants	21 Participants n=7 Participants	50 Participants n=5 Participants	65 Participants n=4 Participants	164 Participants n=21 Participants
Sex: Female, Male Male	27 Participants n=5 Participants	30 Participants n=7 Participants	74 Participants n=5 Participants	66 Participants n=4 Participants	197 Participants n=21 Participants

PRIMARY outcome

Timeframe: Day 28

Population: mITT:treated participants who met disease criteria(blood smears positive for P.falciparum monoinfection;asexual parasitemia=1000-100,000 parasites/microliter \[mcL\];fever/history of fever \>=38 degree Celsius\[C\] \[rectal\],37.2 degree C \[axillary\] or \>=37.5 degree C \[oral\] within last 24 hours).Participants in Ivory Coast center excluded from analysis.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Polymerase Chain Reaction (PCR)-Corrected Adequate Clinical and Parasitologic Response (ACPR) at Day 28 in the Modified Intent-to-treat (mITT) Population	89.27 Percentage of participants Interval 82.77 to 95.77	98.37 Percentage of participants Interval 95.59 to 100.0

PRIMARY outcome

Timeframe: Day 28

Population: Per-Protocol (PP) population was a subset of the mITT population, who received all 3 days of study medication to which they were assigned. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from PP population.

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance at Day 28 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With PCR-corrected ACPR at Day 28 in Per-Protocol (PP) Population	93.08 Percentage of participants Interval 87.32 to 98.84	99.16 Percentage of participants Interval 96.97 to 100.0

SECONDARY outcome

Timeframe: Days 7, 14, 21, 35, 42

Population: mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center excluded from mITT population.

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-Corrected LCF- see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With PCR-corrected ACPR in the mITT Population Day 7	94.17 Percentage of participants Interval 89.55 to 98.78	99.21 Percentage of participants Interval 97.25 to 100.0
Percentage of Participants With PCR-corrected ACPR in the mITT Population Day 14	92.47 Percentage of participants Interval 87.3 to 97.64	99.21 Percentage of participants Interval 97.24 to 100.0
Percentage of Participants With PCR-corrected ACPR in the mITT Population Day 21	91.59 Percentage of participants Interval 86.04 to 97.14	98.37 Percentage of participants Interval 95.65 to 100.0
Percentage of Participants With PCR-corrected ACPR in the mITT Population Day 35	89.27 Percentage of participants Interval 82.68 to 95.86	96.19 Percentage of participants Interval 91.85 to 100.0
Percentage of Participants With PCR-corrected ACPR in the mITT Population Day 42	87.55 Percentage of participants Interval 80.08 to 95.03	96.19 Percentage of participants Interval 91.79 to 100.0

SECONDARY outcome

Timeframe: Days 7, 14, 21, 35, 42

Population: PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.

ACPR (PCR-corrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-corrected LTF (which includes PCR-corrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-corrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With PCR-corrected ACPR in PP Population Day 7	98.25 Percentage of participants Interval 95.39 to 100.0	100.00 Percentage of participants Confidence interval was not calculable as standard error for 100% rate could not be estimated from Kaplan-Meier method.
Percentage of Participants With PCR-corrected ACPR in PP Population Day 14	96.46 Percentage of participants Interval 92.59 to 100.0	100.00 Percentage of participants Confidence interval was not calculable as standard error for 100% rate could not be estimated from Kaplan-Meier method.
Percentage of Participants With PCR-corrected ACPR in PP Population Day 21	95.53 Percentage of participants Interval 91.1 to 99.96	99.16 Percentage of participants Interval 97.03 to 100.0
Percentage of Participants With PCR-corrected ACPR in PP Population Day 35	93.08 Percentage of participants Interval 87.22 to 98.95	96.96 Percentage of participants Interval 92.9 to 100.0
Percentage of Participants With PCR-corrected ACPR in PP Population Day 42	91.29 Percentage of participants Interval 84.31 to 98.28	96.96 Percentage of participants Interval 92.84 to 100.0

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: mITT population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from mITT population.

ACPR (PCR-uncorrected) was defined as asexual P.falciparum parasitologic clearance on Days 7, 14, 21, 28, 35, 42 irrespective of axillary, oral, rectal, or tympanic temperature, without previously meeting the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or PCR-uncorrected LTF (which includes PCR-uncorrected LCF - see measure description in secondary outcome measure 9 and 10, and PCR-uncorrected LPF - see measure description in secondary outcome measure 11 and 12). PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 7	94.17 Percentage of participants Interval 89.55 to 98.78	99.21 Percentage of participants Interval 97.25 to 100.0
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 14	89.08 Percentage of participants Interval 83.05 to 95.11	96.79 Percentage of participants Interval 93.28 to 100.0
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 21	67.87 Percentage of participants Interval 59.02 to 76.72	82.96 Percentage of participants Interval 75.91 to 90.01
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 28	51.55 Percentage of participants Interval 42.07 to 61.02	73.31 Percentage of participants Interval 65.1 to 81.52
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 35	44.67 Percentage of participants Interval 35.24 to 54.11	62.91 Percentage of participants Interval 54.0 to 71.82
Percentage of Participants With PCR-uncorrected ACPR in the mITT Population Day 42	37.80 Percentage of participants Interval 28.58 to 47.02	56.29 Percentage of participants Interval 47.12 to 65.46

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: PP population. For ACPR efficacy endpoints, participants in Ivory Coast center were excluded from the PP population.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 7	98.25 Percentage of participants Interval 95.39 to 100.0	100.00 Percentage of participants Confidence interval not calculable when rate is 100%.
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 14	92.89 Percentage of participants Interval 87.69 to 98.08	97.56 Percentage of participants Interval 94.42 to 100.0
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 21	70.56 Percentage of participants Interval 61.67 to 79.45	83.62 Percentage of participants Interval 76.65 to 90.6
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 28	54.28 Percentage of participants Interval 44.57 to 63.98	73.90 Percentage of participants Interval 65.71 to 82.08
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 35	47.04 Percentage of participants Interval 37.31 to 56.77	63.41 Percentage of participants Interval 54.49 to 72.34
Percentage of Participants With PCR-uncorrected ACPR in PP Population Day 42	39.80 Percentage of participants Interval 30.24 to 49.36	56.74 Percentage of participants Interval 47.54 to 65.94

SECONDARY outcome

Timeframe: Day 0 up to Day 3

Population: mITT population, participants in Ivory Coast center were excluded from mITT population.

ETF defined as participants who met the following criteria: 1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P. falciparum parasitemia 2. Last available asexual P. falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature. 3. Parasitemia (P. falciparum) on Day 3 with fever or 4. Last available P. falciparum parasite count on Day 3 \>=25% of the first available parasite count on Day 0 (Baseline). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Early Treatment Failure (ETF) in the mITT Population (PCR-corrected)	5.83 Percentage of participants	0.79 Percentage of participants

SECONDARY outcome

Timeframe: Day 0 up to Day 3

Population: PP population, participants in Ivory Coast center were excluded from the PP population.

ETF defined as participants who met the following criteria: 1. Developed signs of severe malaria or clinical deterioration that required rescue medication on Days 0, 1, 2 or 3, in the presence of P.falciparum parasitemia 2. Last available asexual P.falciparum parasite count on Day 2 greater than the first available parasite count on Day 0 (Baseline), irrespective of axillary, oral or rectal temperature. 3. Parasitemia (P.falciparum) on Day 3 with fever or 4. Last available P.falciparum parasite count on Day 3 \>=25% of the first available parasite count on Day 0 (Baseline). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With ETF in PP Population (PCR-corrected)	1.75 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: mITT population, participants in Ivory Coast center were excluded from mITT population.

LCF included participants who met any of the following criteria: 1. Development of signs of severe malaria or clinical deterioration requiring rescue medication after Day 3 in the presence of P.falciparum parasitemia, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) 2. Presence of P.falciparum parasitemia and fever on any day from Day 4 onward, without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 7	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 14	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 21	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 28	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 35	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Clinical Failure (LCF) in the mITT Population (PCR-corrected) Day 42	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: PP population, participants in Ivory Coast center were excluded from the PP population.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 7	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 14	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 21	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 28	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 35	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LCF in PP Population (PCR-corrected) Day 42	0 Percentage of participants	0 Percentage of participants

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: mITT population, participants in Ivory Coast center were excluded from mITT population.

LPF: Presence of P. falciparum parasitemia in the mITT population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=126 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 7	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 14	1.67 Percentage of participants	0 Percentage of participants
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 21	2.50 Percentage of participants	0.79 Percentage of participants
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 28	4.17 Percentage of participants	0.79 Percentage of participants
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 35	4.17 Percentage of participants	2.38 Percentage of participants
Percentage of Participants With Late Parasitologic Failure (LPF) in the mITT Population (PCR-corrected) Day 42	5.00 Percentage of participants	2.38 Percentage of participants

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: PP population, participants in Ivory Coast center were excluded from the PP population.

LPF: Presence of P.falciparum parasitemia in the PP population on any day from Day 7 onward and the absence of fever without previously meeting any of the criteria of ETF (see measure description in secondary outcome measures 7 and 8) or LCF (see measure description in secondary outcome measure 9 and 10). PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=114 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=124 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 7	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 14	1.75 Percentage of participants	0 Percentage of participants
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 21	2.63 Percentage of participants	0.81 Percentage of participants
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 28	4.39 Percentage of participants	0.81 Percentage of participants
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 35	4.39 Percentage of participants	2.42 Percentage of participants
Percentage of Participants With LPF in PP Population (PCR-corrected) Day 42	5.26 Percentage of participants	2.42 Percentage of participants

SECONDARY outcome

Timeframe: Day 7, 14, 21, 28, 35, 42

Population: mITT population. Number of participants analyzed (N)=participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.

Percentage of participants who were cleared of asexual parasites. Asexual parasite clearance - clearance of asexual P.falciparum parasitemia within 7 days of initiation of treatment without subsequent recurrence (PCR-corrected) through the day of consideration. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=120 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=128 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 7 (n=120, 128)	93.33 Percentage of participants	99.22 Percentage of participants
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 14 (n=120, 127)	91.67 Percentage of participants	99.21 Percentage of participants
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 21 (n=120, 128)	90.83 Percentage of participants	98.44 Percentage of participants
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 28 (n=120, 127)	89.17 Percentage of participants	98.43 Percentage of participants
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 35 (n=120, 128)	89.17 Percentage of participants	96.88 Percentage of participants
Percentage of Participants With Asexual Parasitologic Response (PCR-corrected) Day 42 (n=120, 127)	88.33 Percentage of participants	96.85 Percentage of participants

SECONDARY outcome

Timeframe: Days 7, 14, 21, 28, 35, 42

Population: mITT population. "N"= participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.

Gametocyte response/absence/clearance: Clearance of P.falciparum gametocytemia (PCR-uncorrected) (attainment of 2 consecutive zero gametocyte counts) without subsequent recurrence through the day of consideration. PCR-uncorrected: not adjusted for molecular testing which determined recrudescence or true failures from reinfection.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=122 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=130 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Percentage of Participants With Gametocytologic Response Day 7 (n=122, 129)	81.97 Percentage of participants	91.47 Percentage of participants
Percentage of Participants With Gametocytologic Response Day 14 (n=122, 130)	81.15 Percentage of participants	91.54 Percentage of participants
Percentage of Participants With Gametocytologic Response Day 21 (n=122, 130)	80.33 Percentage of participants	93.08 Percentage of participants
Percentage of Participants With Gametocytologic Response Day 28 (n=122, 130)	81.97 Percentage of participants	93.08 Percentage of participants
Percentage of Participants With Gametocytologic Response Day 35 (n=122, 130)	81.97 Percentage of participants	92.31 Percentage of participants
Percentage of Participants With Gametocytologic Response Day 42 (n=122, 130)	80.33 Percentage of participants	91.54 Percentage of participants

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: mITT population, including participants in the Ivory Coast center.

Calculated as time of first occurrence of two consecutive time points with temperature less than (\<) 38.0 degrees C/100.4 degrees Fahrenheit (F) (rectal), 37.2 degrees C/99.0 degrees F (axillary), or \<37.5 degrees C/99.5 degrees F (oral).

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=124 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Fever Clearance Time	24.000 Hours Interval 1.0 to 504.0	24.000 Hours Interval 1.0 to 336.0

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: mITT population, including participants in the Ivory Coast center.

Defined as time to first of two consecutive zero asexual P. falciparum parasite (PCR-corrected) counts, regardless of recurrence of parasitemia later. PCR-corrected refers to the use of molecular testing to differentiate recrudescence from reinfection in the context of an efficacy evaluation.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=124 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Asexual Plasmodium Falciparum Parasite Clearance Time	48.000 Hours Interval 24.0 to 504.0	24.000 Hours Interval 1.0 to 48.0

SECONDARY outcome

Timeframe: Day 0 through Day 3

Population: mITT population, including participants in the Ivory Coast center.

Nadir hemoglobin for each participant was defined as the minimum hemoglobin values obtained from Day 0 through Day 3.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=124 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Nadir Hemoglobin Level	9.63 grams per deciliter (g/dL) Standard Deviation 1.53	9.82 grams per deciliter (g/dL) Standard Deviation 1.61

SECONDARY outcome

Timeframe: Day 14, 28, 42

Population: mITT population. "N" = number of participants with evaluable data, including participants in the Ivory Coast center. "n"=participants who were evaluable at specified time points for each arm, respectively.

Change from nadir = observation minus nadir. Nadir defined as the minimum value for each participant on Days 0-3.

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=122 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=128 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Change From Nadir Hemoglobin Level at Days 14, 28, and 42 Change at Day 14 (n=122, 127)	0.52 g/dL Standard Error 0.11	0.44 g/dL Standard Error 0.13
Change From Nadir Hemoglobin Level at Days 14, 28, and 42 Change at Day 28 (n=122, 127)	1.15 g/dL Standard Error 0.11	0.96 g/dL Standard Error 0.13
Change From Nadir Hemoglobin Level at Days 14, 28, and 42 Change at Day 42 (n=122, 128)	1.29 g/dL Standard Error 0.12	1.14 g/dL Standard Error 0.14

SECONDARY outcome

Timeframe: Baseline (Day 0) to Day 42

Population: mITT population, including participants in the Ivory Coast center.

Time from the day of clearance to the time of recurrence of asexual P.falciparum parasitemia (PCR-uncorrected).

Outcome measures

Outcome measures
Measure	Cohort 2: Azithromycin + Chloroquine n=124 Participants Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 Participants Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Time to Recurrence of Parasitemia	34 Days Interval 2.0 to 42.0	NA Days Interval 7.0 to 43.0 Median time to recurrence could not be calculated for participants in the Artemether-Lumefantrine treatment groups since fewer than 50% of the participants experienced recurrent parasitemia during the study.

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: Data for this outcome measure was not analyzed as per change in planned analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to Day 42

Population: Data for this outcome measure was not analyzed as per change in planned analysis.

A genetic marker, P.falciparum chloroquine resistance transporter (PfCRT), indicative of P.falciparum chloroquine resistance was to be determined from blood blots obtained on Day 0 and at the time of treatment failure. Treatment failure was defined as any of the following events that a participant experienced from Day 0 through the Day 42 visit: ETF (see measure description in secondary outcome measures 7 and 8), LCF (PCR corrected) (see measure description in secondary outcome measure 9 and 10), or LPF (PCR corrected) (see measure description in secondary outcome measure 11 and 12). Recrudescence of asexual P.falciparum parasites was considered treatment failure.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1: Azithromycin + Chloroquine

Serious events: 1 serious events

Other events: 40 other events

Deaths: 0 deaths

Cohort 1: Artemether + Lumefantrine

Serious events: 2 serious events

Other events: 36 other events

Deaths: 0 deaths

Cohort 2: Azithromycin + Chloroquine

Serious events: 0 serious events

Other events: 103 other events

Deaths: 0 deaths

Cohort 2: Artemether + Lumefantrine

Serious events: 1 serious events

Other events: 99 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1: Azithromycin + Chloroquine n=55 participants at risk Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base). Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 1: Artemether + Lumefantrine n=51 participants at risk Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 1 included participants between \>=5 years of age and \<=12 years of age.	Cohort 2: Azithromycin + Chloroquine n=124 participants at risk Azithromycin/Chloroquine administered orally once daily for 3 days as a combination tablet (300 milligrams \[mg\] Azithromycin and 100 mg Chloroquine or 150 mg Azithromycin and 50 mg Chloroquine) on Days 0, 1, 2. The combination tablets were administered on the basis of body weight approximately 30 milligram/kilogram (mg/kg) Azithromycin + approximately 10 mg base/kg Chloroquine base. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.	Cohort 2: Artemether + Lumefantrine n=131 participants at risk Artemether/Lumefantrine administered orally once daily for 3 days as a combination tablet (20 mg Artemether and 120 mg Lumefantrine) on Days 0, 1, 2. Cohort 2 included participants between \>=6 months of age to \<=59 months of age.
Infections and infestations Hepatitis B	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/124 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/131 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Malaria	1.8% 1/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/124 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/131 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Sepsis	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	2.0% 1/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/124 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/131 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Nervous system disorders Convulsion	0.00% 0/55 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/51 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/124 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.76% 1/131 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER