TrialPanorama/TrialPanorama-database huggingface dataset:
Study: NCT01572324

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine
Description: HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.
Study: NCT01830192

Intervention type: OTHER
Group type: OTHER
Intervention: Training set
Description: We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative

Intervention type: OTHER
Group type: OTHER
Intervention: VERIFICATION SET
Description: We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
Study: NCT00880321

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436
Description: Dose escalation with GSK2118436 may proceed until either a maximum tolerated dose is established, or the toxicokinetic safety limit is reached.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: GSK2118436
Description: Part 2 will use the recommended Part 2 dose of GSK2118436 identified during Part 1 of the study. Biologically active doses will be identified by measurement of pharmacodynamic markers in tumor tissue and blood across a range of doses and these doses may be explored in Part 2.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Midazolam
Description: Midazolam will be administered alone and with GSK2118436 in a sub-set of subjects in Part 2 to study the effect of GSK2118436 on CYP3A using midazolam as a probe.
Study: NCT00828906

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: DuoTrav
Description: DuoTrav Eye Drops
Study: NCT03555604

Intervention type: DIAGNOSTIC_TEST
Intervention: Gastric ultrasound
Description: Gastric ultrasound to measure antrum cross sectional area
Study: NCT04003662

Intervention type: DEVICE
Intervention: Vital Signs Measurement
Description: Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Intervention type: DEVICE
Intervention: Vital Signs Measurement
Description: Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.

Intervention type: DEVICE
Intervention: Vital Signs Measurement
Description: Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.
Study: NCT04466423

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)
Description: The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question. Group leaders will be provided 3-4 discussion questions for each session. The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together. Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies. The remainder of the time can be used for socializing and building relationships with colleagues.

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)
Description: The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question. Group leaders will be provided 3-4 discussion questions for each session. The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together. Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies. The remainder of the time can be used for socializing and building relationships with colleagues.
Study: NCT02443025

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Teens Against Tobacco Use
Description: Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.
Study: NCT03769805

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anlotinib
Description: Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week.
Study: NCT03504735

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Therapeutic Lifestyle Change
Description: Monthly consult with a dietitian and fitness instructor.

Intervention type: BEHAVIORAL
Group type: PLACEBO_COMPARATOR
Intervention: Therapeutic Lifestyle Change
Description: Monthly consult with a dietitian and fitness instructor.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Caduet Pill
Description: Take once daily.

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Description: Take once daily.
Study: NCT01651936

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-8457 100 mg
Description: MK-8457 100 mg dosed orally BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: MK-8457 100 mg
Description: MK-8457 100 mg dosed orally BID

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: MTX dosed at the stable dose received upon study entry

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Methotrexate
Description: MTX dosed at the stable dose received upon study entry

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: MTX dosed at the stable dose received upon study entry

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Dose-match placebo
Description: Dose-matched placebo dosed orally BID
Study: NCT03893864

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Administration of a product with Fitosomed Ubiquinone
Description: Healthy runner athletes, \> 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Coenzyme Q10 level in muscle biopsies
Description: Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Coenzyme Q10 level in plasma, blood cells, urine cells
Description: Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Coenzyme Q10 level in plasma, blood cells, urine cells
Description: Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not

Intervention type: DIAGNOSTIC_TEST
Group type: ACTIVE_COMPARATOR
Intervention: Total antioxidant capacity after strenous exercise
Description: Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber

Intervention type: DIAGNOSTIC_TEST
Group type: EXPERIMENTAL
Intervention: Total antioxidant capacity after strenous exercise
Description: Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber
Study: NCT02708238

Intervention type: DIETARY_SUPPLEMENT
Group type: EXPERIMENTAL
Intervention: Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)

Intervention type: DIETARY_SUPPLEMENT
Group type: ACTIVE_COMPARATOR
Intervention: Lactobacillus reuteri DSM 17938 (108 CFU)

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Simethicone
Study: NCT03904537

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: anti-PD-1 antibody-activated TILs
Description: Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy
Study: NCT03352063

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Prolonged sitting with exercise
Description: Subjects will commit to sitting more than 11 hours per day and taking less than 5000 steps per day while participating in exercise training.

Intervention type: BEHAVIORAL
Group type: ACTIVE_COMPARATOR
Intervention: Active walking with exercise.
Description: Subjects will commit to sitting less than 5 hours per day and taking more than 10000 steps per day while participating in exercise training.
Study: NCT02569320

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO
Study: NCT02779283

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cyclophosphamide
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Cytarabine
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dasatinib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dasatinib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Dexamethasone
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Doxorubicin Hydrochloride
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idarubicin
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idelalisib
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Idelalisib
Description: Given PO

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: In Vitro Kinase Inhibitor Assay
Description: Correlative studies
Study: NCT02583867

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Exercise
Description: Subjects will engage in supervised exercise sessions for 12 weeks. Each week will consist of at least three exercise sessions with a total duration of weekly exercise of approximately 150 minutes.
Study: NCT02425033

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: POEM
Description: Under general anesthesia, patient undergoes upper endoscopy and a small longitudinal submucosal incision is created and a dilating balloon is inserted submucosally via the created incision. The balloon is slightly inflated to allow entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via endoscopic or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified using endoscopic landmarks. Using a dissection knife, the clearly visible circular muscles are divided. The longitudinal layer is left intact and the mucosal entry is closed.
Study: NCT01935700

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Colchicine
Description: Adjustment the dosage of colchicine during study:~The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day.
Study: NCT04032951

Intervention type: OTHER
Group type: EXPERIMENTAL
Intervention: Fine Needle Tissue Acquisition
Description: diagnostic
Study: NCT00348036

Intervention type: BEHAVIORAL
Group type: EXPERIMENTAL
Intervention: Group Intervention for Interpersonal Trauma
Description: Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences. Groups will be comprised of three components at each meeting: psycho-education, current relationship issues, and coping skills. Each group session will focus on a different aspect of education. Next, relationship difficulties typically associated with the symptoms discussed in that module will be addressed, and there will be group discussion about participants' relationship difficulties. Each group will end with the therapist teaching a coping skill that fits with the issues discussed earlier.

Intervention type: OTHER
Group type: ACTIVE_COMPARATOR
Intervention: Information only
Description: Participants will receive information about PTSD and depression, in the form of a brochures and a DVD about trauma and its emotional consequences.
Study: NCT04060459

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Paclitaxel-binding albumin
Description: Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
Study: NCT03257241

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: A arm (DA-90)
Description: After confirming the diagnosis, assuming the inclusion criteria and exclusion criteria are respected, the patients are randomized to one of two standard induction treatment protocols (A arm: DA-90 vs B arm: DAC). After completing induction I, an early bone marrow assessment is performed on day 14 from the beginning of the treatment (+ day 7 after finishing chemotherapy) using the cytological method and MRD is assessed by the immunophenotyping method. Therapeutic decision is taken on the basis of the cytological assessment. Patients, in whom the percentage of blasts in the bone marrow on day 14 is \> 10%, receive early induction II from day 16. An Immunophenotype test is a complementary examination.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: B arm (DAC)
Description: After confirming the diagnosis, assuming the inclusion criteria and exclusion criteria are respected, the patients are randomized to one of two standard induction treatment protocols (A arm: DA-90 vs B arm: DAC). After completing induction I, an early bone marrow assessment is performed on day 14 from the beginning of the treatment (+ day 7 after finishing chemotherapy) using the cytological method and MRD is assessed by the immunophenotyping method. Therapeutic decision is taken on the basis of the cytological assessment. Patients, in whom the percentage of blasts in the bone marrow on day 14 is \> 10%, receive early induction II from day 16. An Immunophenotype test is a complementary examination.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: A arm (CLAG-M)
Description: Patients who do not achieve CR after two courses of induction therapy or patients with relapsed leukemia are eligible for emergency treatment (salvage) according to the CLAG- M or FLAG-IDA protocol.

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: B arm (FLAG-IDA)
Description: Patients who do not achieve CR after two courses of induction therapy or patients with relapsed leukemia are eligible for emergency treatment (salvage) according to the CLAG- M or FLAG-IDA protocol.
Study: NCT02696954

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine
Description: Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amodiaquine
Description: Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Amodiaquine
Description: Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine
Description: Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Amodiaquine
Description: Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Amodiaquine
Description: Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Primaquine
Description: Primaquine on Day 0 Washout period: more than 1 week

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Primaquine
Description: Primaquine on Day 0 Washout period: more than 1 week
Study: NCT02779283

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: In Vitro Kinase Inhibitor Assay
Description: Correlative studies

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Leucovorin Calcium
Description: Given IV
Study: NCT02696954

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Primaquine
Description: Artemether-lumefantrine on Day 0, 1 and 2 + Primaquine on Day 0 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Amodiaquine + Primaquine
Description: Artemether-lumefantrine Day 0, 1 and 2 + Amodiaquine on Day 0, 1 and 2 + Primaquine on Day 0 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Amodiaquine + Primaquine
Description: Artemether-lumefantrine Day 0, 1 and 2 + Amodiaquine on Day 0, 1 and 2 + Primaquine on Day 0 Washout period: more than 6 weeks

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Artemether-lumefantrine + Primaquine
Description: Artemether-lumefantrine on Day 0, 1 and 2 + Primaquine on Day 0
Study: NCT04604405

Intervention type: RADIATION
Group type: EXPERIMENTAL
Intervention: photobiomodulation
Description: 650nm low energy red light eye irradiation
Study: NCT01500044

Intervention type: PROCEDURE
Group type: EXPERIMENTAL
Intervention: Program targeting the opening of foramen
Description: Rehabilitation intervention that specifically targets the opening of the intervertebral foramen

Intervention type: PROCEDURE
Group type: ACTIVE_COMPARATOR
Intervention: Conventional Rehabilitation Program
Description: Program used in previous randomized clinical trials in this population
Study: NCT06091592

Intervention type: OTHER
Intervention: Serum autotaxın levels
Description: Autotaxin molecule is a nucleotide pyrophosphatase/phosphodiesterase enzyme.

Intervention type: OTHER
Intervention: Serum autotaxın levels
Description: Autotaxin molecule is a nucleotide pyrophosphatase/phosphodiesterase enzyme.
Study: NCT02771600

Intervention type: DEVICE
Group type: EXPERIMENTAL
Intervention: Buzzy
Description: See arm description

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Topical anaesthetic cream
Description: See arm description
Study: NCT02779283

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methotrexate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Methylprednisolone Sodium Succinate
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ponatinib Hydrochloride
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ponatinib Hydrochloride
Description: Given PO

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Rituximab
Description: Given IV

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib Phosphate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Ruxolitinib Phosphate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib Tosylate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sorafenib Tosylate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunitinib Malate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Sunitinib Malate
Description: Given PO

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Vincristine Sulfate
Description: Given IV
Study: NCT00632931

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vorinostat
Description: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: vorinostat
Description: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat 800 mg capsules (Period 1) crossing over to Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1) crossing over to Single dose of vorinostat 800 mg capsules (Period 2). Part 2: All patients will receive 400 mg vorinostat capsules once daily. Treatment will continue until disease progression or intolerable toxicity.

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Comparator: placebo (unspecified)
Description: A 2-part, crossover study. Part 1: Arm A: Single dose of vorinostat Placebo capsules (Period 2) Arm B: Single dose of vorinostat Placebo capsules (Period 1).
Study: NCT02226926

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Aggrenox

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Persantin Retard

Intervention type: DRUG
Group type: ACTIVE_COMPARATOR
Intervention: Acetylsalicylic acid
Study: NCT02348359

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: X-82

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: X-82

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: X-82

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anti-VEGF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anti-VEGF

Intervention type: DRUG
Group type: EXPERIMENTAL
Intervention: Anti-VEGF

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Anti-VEGF

Intervention type: DRUG
Group type: PLACEBO_COMPARATOR
Intervention: Placebo
Study: NCT01955109

Intervention type: BIOLOGICAL
Group type: EXPERIMENTAL
Intervention: Viaskin Peanut 250 mcg
Description: Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
Study: NCT01122784

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: rF1V vaccine (with Adjuvant)
Description: 80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: rF1V vaccine (without Adjuvant)
Description: 80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: rF1V vaccine (with Adjuvant)
Description: 80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: rF1V vaccine (without Adjuvant)
Description: 80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121