Malaria, VivaxPhase 3NCT06666491
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
A Phase 3 study testing Tafenoquine, Primaquine and Chloroquine in people with Malaria, Vivax, run by GlaxoSmithKline at 5 sites in India.
Trial summary
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India. Read more about this study
- Who is it for?
- Ages 2 to 64 years
- Conditions the study is for
- Malaria, Vivax
- What is being tested?
- Tafenoquine, Primaquine and Chloroquine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 5 sitesIndia
- Study dates
- 13 Nov 2024to 14 May 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 64 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Males and females >=2 years of age and under (<) 65 years of age, weighing >10 kg.
- The participant has a positive malarial smear for P. vivax with a parasite density of >100/microliter and <100,000/microliter.
- The participant has a screening Hb value >8 g/dL.
- The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
- The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off is applicable for both males and females).
- A female participant is eligible to participate if she is not pregnant or breastfeeding, and if one of the following conditions applies:
Show all 10Show fewer
- Is a woman of non-childbearing potential (WONCBP) as defined in
- Is a Women of Childbearing Potential (WOCBP) and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, during the study intervention period and for at least 90 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
- A WOCBP must test negative on a highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.
- The participant is willing and able to comply with the procedures described in the study protocol. The participant or parent/legal guardian, as applicable, has given written informed, dated consent; and the participant has given written assent, if applicable, to participate in the study.
Who cannot join
- The participant has severe P. vivax malaria as defined by WHO criteria [WHO, 2023].
- The participant has a mixed malaria infection (identified by a malarial smear).
- The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
- The participant has a history of porphyria, psoriasis, or epilepsy.
- The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs), chloroquine, tafenoquine, primaquine, any other 4- or 8-AQ or any of their respective excipients.
- The participant has received treatment with any investigational drug within 30 days of study entry, or within 5 half-lives, whichever is longer.
Show all 21Show fewer
- The participant has previously enrolled in this study.
- The participant has a recent history of illicit drug abuse or heavy alcohol intake that in the opinion of the investigator could compromise full participation in the study or adherence to study procedures.
- Participants with a current or past history of serious psychiatric disorders.
- The participant has a clinically significant concurrent illness (e.g., pneumonia, tuberculosis, meningitis, septicemia, dengue, coagulopathy, severe hemorrhage, or febrile convulsions prior to consent) or a pre-existing condition (e.g., renal disease, malignancy, or severe malnutrition according to WHO child growth standards) or systemic disease predisposing patients to suffer from granulocytopenia, such as rheumatoid arthritis and lupus erythematosus or severe ocular disease.
- The participant is known to be HIV-infected and/or is currently on antiretroviral therapy.
- The participant is regularly using drugs with hemolytic potential.
- The participant has a QT corrected by Fridericia's formula (QTcF) >450 msec, evidence of bradycardia (<50 beats per min) or ventricular arrhythmias on the screening ECG, a history of cardiac disease (e.g., myocardial infarction, congenital heart disease, or arrhythmia), hypokalemia (<2.9 millimoles per liter [mmol/L]) or hyperkalemia (>=6.0 mmol/L) at Screening.
- The participant has taken drugs with antimalarial activity (e.g., artemisinin-based combination therapies, mefloquine, primaquine, chloroquine, tafenoquine or any other 4-AQ) within 30 days prior to study entry.
- The participant has taken or will likely require during the study the use of:
- Histamine-2 blockers (restricted to first 3 days whilst receiving CQ)
- Antacids (restricted to first 3 days whilst receiving CQ)
- Drugs of the biguanide class (i.e., phenformin, metformin, buformin)
- Anti-arrhythmic agents (i.e., dofetilide, procainamide, pilsicainide)
- Medications that prolong the QTc interval
- The participant has liver transaminases (ALT/AST) >2 times the upper limit of normal (ULN).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
India5 sites, 5 recruiting
- Recruiting
GSK Investigational Site
Ahmedabad, 380008
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Bikaner, 334001
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Kolkata, 700073
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Mumbai, 400012
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
- Recruiting
GSK Investigational Site
Surat, 395004
US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com
About this study
Official title: A Randomized, Open-label, Multi-center, Interventional Phase 3 Study of the Efficacy and. Safety of Tafenoquine Compared to Primaquine (Both Co-administered With Chloroquine) for the Radical Cure (Relapse Prevention) of Plasmodium Vivax (P. Vivax) Malaria in Indian Participants (Pediatric and Adult Population)
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
- Conditions
- Malaria, Vivax
- Being tested
- Tafenoquine, Primaquine, Chloroquine
- Medical subject headings
- Malaria, Vivax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TafenoquineDrug
A single dose of TQ will be administered orally on Day 1 or Day 2.
PrimaquineDrug
A single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2).
ChloroquineDrug
A single dose of CQ will be administered orally, daily, on Days 1 to 3.
| Study group | Role | What they receive |
|---|---|---|
| TQ/CQ | Experimental | Participants in this group receive a single dose of TQ on Day 1 or Day 2 and a single dose of CQ daily, on Days 1 to 3. Receives: Drug: Tafenoquine; Drug: Chloroquine |
| PQ/CQ | Active comparator | Participants in this group receive a single dose of PQ daily from Day 1 or 2, up to Day 14 (or Day 15 if PQ started on Day 2) and a single dose of CQ daily, on Days 1 to 3. Receives: Drug: Primaquine; Drug: Chloroquine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
Two consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow-up period, and a negative P. vivax smear at the 6-month assessment.
Measured: Up to Month 6
Secondary outcomes (26)
Number of participants with clinically relevant hemolysis change from baseline
A decrease in hemoglobin of greater than or equal to (>=) 30% or greater than (>) 3g/deciliter (dL) from baseline; or an overall drop in hemoglobin below 6.0 g/dL or complications thereof (e.g., required transfusions, acute renal failure) are considered clinically relevant hemolysis changes.
Measured: Up to Day 14
Time to recurrence of P. vivax malaria
Recurrence is defined as a positive blood smear for P. vivax parasites within the 6-month follow-up period, after clearance of blood-stage parasitemia.
Measured: Up to Month 6
Number of participants with treatment emergent adverse events (TEAEs) up to Month 6
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Month 6
Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria
Severity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening, Grade 5-Death.
Measured: Up to Month 6
Number of participants with drug related TEAEs
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Month 6
Number of participants with serious AEs (SAEs)
A SAE is any untoward medical occurrence that results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization or result in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant.
Measured: Up to Month 6
Number of participants with AEs resulting in treatment discontinuation
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Month 6
Number of participants with AEs leading to study withdrawal
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Month 6
Number of participants with AEs considered to be hematologically related
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Month 6
Number of deaths
Measured: Up to Month 6
Liver chemistry changes meeting Hy's criteria
Hy's criteria cases were defined as any elevated alanine aminotransferase (ALT) >=3 times upper limit of normal (ULN) and total bilirubin >=2 times ULN or ALT >=3 times ULN and international normalized ratio (INR) >1.5.
Measured: Up to Month 6
Laboratory parameters meeting >= Division of AIDS (DAIDs) Grade 3 criteria
Measured: Up to Month 6
Vital sign parameters meeting >=DAIDs Grade 3 criteria
Measured: Up to Month 6
Number of participants with TEAEs up to Week 4
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Up to Week 4
Change from baseline at each study visit for clinical chemistry parameters (ALT, AST, ALP)
Data for alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) is measured in international units/liter (IU/L).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (CPK)
Data for creatine phosphokinase (CPK) is measured in units per liter (U/L).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (total bilirubin, indirect bilirubin, blood urea nitrogen [BUN]/Urea, and serum creatinine)
Clinical chemistry parameters are measured in milligrams per decilitre (mg/dL).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (serum electrolytes)
Data for serum electrolytes is measured in millimoles per liter (mmol/L).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (platelet count)
Platelets are measured in number of platelets per microliter (µL).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (red blood cell [RBC] count)
Data for RBC is measured in millions of cells per microliter (number of RBCs x10^6/µL).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular volume [MCV])
Data for MVC is measured in femtoliters (fL).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular hemoglobin [MCH])
Data for MCH is measured in picograms (pg) per cell.
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (percentage of reticulocytes)
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (white blood cell count [WBC] with differential)
Data for neutrophils, lymphocytes, monocytes, eosinophils and basophils is presented as a count, which measures a percentage (%) of the WBC.
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hemoglobin)
Hemoglobin is measured in grams per deciliter (g/dL).
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hematocrit)
Hematocrit is measured in volume percentage (%) of RBC in blood.
Measured: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start13 Nov 2024
- Primary completion14 May 2027 (estimated)
- Study completion14 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, VivaxStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06666491
- Sponsor's protocol ID
- 208550
- Status last verified
- Sep 2026
- First submitted
- 18 Oct 2024
- Last updated
- 1 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Multi-center, Interventional Phase 3 Study of the Efficacy and. Safety of Tafenoquine Compared to Primaquine (Both Co-administered With Chloroquine) for the Radical Cure (Relapse Prevention) of Plasmodium Vivax (P. Vivax) Malaria in Indian Participants (Pediatric and Adult Population)
- ClinicalTrials.gov ID
- NCT06666491
- Acronym / sponsor ID
- 208550
- Conditions
- Malaria, Vivax
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2024 (actual)
- Primary completion
- 14 May 2027 (estimated)
- Study completion
- 14 May 2027 (estimated)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQ/CQ | Experimental | Drug: Tafenoquine, Drug: ChloroquineParticipants in this group receive a single dose of TQ on Day 1 or Day 2 and a single dose of CQ daily, on Days 1 to 3. |
| PQ/CQ | Active comparator | Drug: Primaquine, Drug: ChloroquineParticipants in this group receive a single dose of PQ daily from Day 1 or 2, up to Day 14 (or Day 15 if PQ started on Day 2) and a single dose of CQ daily, on Days 1 to 3. |
Who may qualify
- Ages
- 2 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- Males and females >=2 years of age and under (<) 65 years of age, weighing >10 kg.
- The participant has a positive malarial smear for P. vivax with a parasite density of >100/microliter and <100,000/microliter.
- The participant has a screening Hb value >8 g/dL.
- The participant has an axillary temperature of 37.5°C or history of fever 48 hours before recruitment.
- The participant has a G6PD value (measured using the SD Biosensor STANDARDTM G6PD test) 6.1 units/gram (U/g) Hb for G6PD activity (6.1 U/g Hb cut-off is applicable for both males and females).
Key exclusion criteria (21 listed)
- The participant has severe P. vivax malaria as defined by WHO criteria [WHO, 2023].
- The participant has a mixed malaria infection (identified by a malarial smear).
- The participant has a condition that may affect absorption of study medication, such as severe vomiting (no food or inability to take food during the previous 8 hours).
- The participant has a history of porphyria, psoriasis, or epilepsy.
- The participant has a history of allergy, intolerance to or a known contraindication to the use of mefloquine (or other aryl amino alcohol drugs), chloroquine, tafenoquine, primaquine, any other 4- or 8-AQ or any of their respective excipients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TafenoquineA single dose of TQ will be administered orally on Day 1 or Day 2. | Drug | TQ/CQ |
| PrimaquineA single dose of PQ will be administered orally, daily, on Day 1 or 2 to Day 14 (or Day 15 if PQ started on Day 2). | Drug | PQ/CQ |
| ChloroquineA single dose of CQ will be administered orally, daily, on Days 1 to 3. | Drug | PQ/CQ, TQ/CQ |
Primary outcome
Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit
Time frame: Up to Month 6
Two consecutive negative blood smears between Day 2 and Day 8, no positive blood smear for P. vivax parasites at any point during the 6-month follow-up period, and a negative P. vivax smear at the 6-month assessment.
26 secondary outcomes
Number of participants with clinically relevant hemolysis change from baseline
Time frame: Up to Day 14
Time to recurrence of P. vivax malaria
Time frame: Up to Month 6
Number of participants with treatment emergent adverse events (TEAEs) up to Month 6
Time frame: Up to Month 6
Number of participants with TEAEs meeting >= Division of Acquired Immunodeficiency Syndrome (DAIDS) Grade 3 criteria
Time frame: Up to Month 6
Number of participants with drug related TEAEs
Time frame: Up to Month 6
Number of participants with serious AEs (SAEs)
Time frame: Up to Month 6
Number of participants with AEs resulting in treatment discontinuation
Time frame: Up to Month 6
Number of participants with AEs leading to study withdrawal
Time frame: Up to Month 6
Number of participants with AEs considered to be hematologically related
Time frame: Up to Month 6
Number of deaths
Time frame: Up to Month 6
Liver chemistry changes meeting Hy's criteria
Time frame: Up to Month 6
Laboratory parameters meeting >= Division of AIDS (DAIDs) Grade 3 criteria
Time frame: Up to Month 6
Vital sign parameters meeting >=DAIDs Grade 3 criteria
Time frame: Up to Month 6
Number of participants with TEAEs up to Week 4
Time frame: Up to Week 4
Change from baseline at each study visit for clinical chemistry parameters (ALT, AST, ALP)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (CPK)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (total bilirubin, indirect bilirubin, blood urea nitrogen [BUN]/Urea, and serum creatinine)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for clinical chemistry parameters (serum electrolytes)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (platelet count)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (red blood cell [RBC] count)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular volume [MCV])
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (mean corpuscular hemoglobin [MCH])
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (percentage of reticulocytes)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (white blood cell count [WBC] with differential)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hemoglobin)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Change from baseline at each study visit for haematology parameters (hematocrit)
Time frame: At Days 5, 8, 15, 29, 60, 90, 120, 150 and 180
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
Related trials for Malaria, Vivax
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
Induced Blood-Stage Malaria in Healthy Malaria-Naive Adults to Assess the Safety and Infectivity of Plasmodium Vivax Challenge Agent and Evaluate Transmission in Mosquito Feeding Assays
Malaria
Not yet recruitingPhase 1
Safety and Immunogenicity of the Recombinant Malaria Vaccines in Healthy Adults Aged 18-50 Years
Malaria Vaccine
Not yet recruitingPhase 2
This is a Clinical Study to Assess Whether the Combination of SJ733 and Tafenoquine Will be a Safe and Rapidly Acting Anti-malarial for the Radical Cure of P. Vivax Malaria
Malaria, Malaria Vivax
RecruitingPhase 4
Southeast Asia Dose Optimization of Tafenoquine
Plasmodium Vivax Malaria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tafenoquine, Primaquine and Chloroquine in people with Malaria, Vivax, run by GlaxoSmithKline at 5 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants remaining recurrence-free during the 6 months post-treatment and have a negative blood smear at the Month 6 (end of study [EOS]) visit (time frame: Up to Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.