Safety, Tolerability and Efficacy of PfSPZ Vaccine in Healthy Children and Infants 5 Months - 9 Years Living in Kenya

NCT02687373 | Completed Phase 1

• 2 other identifiers: KEMRI/SERU/CGHR/017/3129CDC IRB Protocol #6787
• Study Type: interventional
• Target: 337
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted in Siaya County in Nyanza Province, western Kenya. Healthy children aged 5 months through 9 years of age living within approximately 10 km of the study clinic(s) (Siaya County Referral Hospital, or Wagai dispensary, a government health facility in Wagai division) will be eligible for participation in Part 1; healthy infants aged 5 months - 12 months inclusive will be eligible for Part 2.

Conditions

Malaria

Keywords

Plasmodium falciparum; PfSPZ Vaccine

Outcome Measures

Primary Outcomes (7)

• Part 1 - Incidence and type of adverse events (AE)

  Incidence and type of solicited and unsolicited adverse events including breakthrough malaria infections and clinical laboratory assessments (hematological, liver and renal function) will be collected within 28 days after each vaccination. Proportions of participants with AEs and frequencies of individual AEs will be calculated and compared against participants in the same age category and dose group receiving placebo.

  Collected from day of each vaccination until day 28 post vaccination

• Part 1 - Incidence and type of possibly/probably or definitely related serious adverse events (SAEs)

  Incidence of all hospitalizations, deaths, disabilities caused by at least possibly related SAEs during study participation

  Collected from day of first vaccination until close out visit (28 days for 3 lower doses, 84 days for 2 higher doses)

• Part 1 - Assessment of Pf-specific antibodies in the different age categories and to the different vaccine doses

  Collection of blood samples for antibodies on day 8 after each vaccination. Following vaccination serum will be taken and an assessment of Plasmodium falciparum (Pf)f-specific antibodies against specific malaria proteins such as the circumsporozoite protein (CSP) PfCSP and whole Pf sporozoites (SPZ) will be determined by enzyme-linked immunosorbent assay (ELISA) and automated immunofluorescence assay (aIFA) respectively.

  Collected 1 week after each vaccination

• Part 2 - Incidence and type of adverse events in infants 5-12 months of age following administration of PfSPZ Vaccine

  Incidence and type of solicited and unsolicited adverse events including breakthrough malaria infections and clinical laboratory assessments (hematological, liver and renal function) will be collected during 28 days after each vaccination.

  Collected from day of each vaccination until day 28 post vaccination

• Part 2 - Incidence and type of possibly/probably or definitely related serious adverse events (SAEs) following administration of PfSPZ Vaccine

  Incidence of all hospitalizations, deaths, disabilities caused by at least possibly related to the study product during the 12-month follow-up period.

  Collected from day of first vaccination through the 12-month follow-up period.

• Part 2 - Assessment of Pf-specific antibodies in infants of 5-12 months to three vaccinations of PfSPZ Vaccine

  Collection of blood samples for antibodies on day 8 after vaccination 1 and 2 and day 15 after the third PfSPZ vaccination. Following vaccination serum will be taken and an assessment of Plasmodium falciparum (Pf)f-specific antibodies against specific malaria proteins such as the circumsporozoite protein (CSP) PfCSP and whole Pf sporozoites (SPZ) will be determined by enzyme-linked immunosorbent assay (ELISA) and automated immunofluorescence assay (aIFA) respectively.

  Collected 1 week after the first and second vaccination and 2 weeks after the third vaccination.

• Part 2 - Ratio of Pf positive blood smear (+BS) in experimental arm to Pf +BS in placebo arm to determine efficacy of PfSPZ Vaccine during 6 months after last dose

  Efficacy against malaria infection of PfSPZ Vaccine administered to infants 5-12 months of age in 3 doses by passive and active surveillance for naturally acquired Pf infection, measured by blood smear microscopy, during 6 months following the last vaccine dose.

  2 weeks to 6 months after the last vaccine dose

Secondary Outcomes (4)

• Part 2 - Ratio of Pf +BS in experimental arm to Pf +BS in placebo arm to determine efficacy of PfSPZ Vaccine during 12 months after last dose

  2 weeks to 12 months after the last vaccine dose

• Part 2 - Ratio of Pf positive PCR in experimental arm to Pf positive PCR in placebo arm to determine efficacy against submicroscopic malaria infection of PfSPZ Vaccine following 6 and 12 months after the last dose

  2 weeks to 6 and 12 months after the last vaccine dose

• Part 2 - Assessment of Pf-specific antibodies, parasite-specific T cell responses and RNA sequencing.

  Before the first vaccination, 1 week after vaccination 1 and 2, 2 weeks after vaccination 3 and at 6 months and 12 months after the last vaccination

• Part 2 - Assessment of Pf-specific antibodies, parasite-specific T cell responses and RNA sequencing to determine correlation of immune response with efficacy

  Entire study period

Other Outcomes (3)

• Ratio of Pf +BS in experimental arm to Pf +BS in placebo arm to determine efficacy against Pf infection at certain parasite thresholds in each study arm

  2 weeks to 12 months after last vaccination

• Ratio of Pf +BS in experimental arm to Pf +BS in placebo arm to determine efficacy against clinical malaria and malaria hospitalization in each study arm

  2 weeks to 12 months after last vaccination

• Effect of vaccination on anemia

  6 months and 12 months after last vaccination

Study Arms (30)

Part 1: Grp 1A - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=8; Dose of 4.5 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination.

Biological: PfSPZ Vaccine

Part 1: Grp 1A - Normal Saline

PLACEBO COMPARATOR

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination.

Other: Normal Saline

Part 1: Grp 1B - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=8; Two doses of 9.0 x 10\^5 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 1A dose has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 1B - Normal Saline

PLACEBO COMPARATOR

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 1A dose has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 1: Grp 1C - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=8; Two doses of 1.8 x 10\^6 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after the 1st dose of Grp 1B has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 1C - Normal Saline

PLACEBO COMPARATOR

Children aged 5-9 years (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered after the 1st dose of Grp 1B has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 1: Grp 2A - PfSPZ Vaccine

EXPERIMENTAL

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=8; Dose of 1.35 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after the 1st dose of Grp 1B has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 2A - Normal Saline

PLACEBO COMPARATOR

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after the 1st dose of Grp 1B has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 2B - PfSPZ Vaccine

EXPERIMENTAL

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=8; Dose of 2.7 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2A has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 2B - Normal Saline

PLACEBO COMPARATOR

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2A has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 2C - PfSPZ Vaccine

EXPERIMENTAL

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=8; Dose of 4.5 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2B has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 2C - Normal Saline

PLACEBO COMPARATOR

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2B has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 2D - PfSPZ Vaccine

EXPERIMENTAL

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=8; Two doses of 9.0 x 10\^5 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 2C has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 2D - Normal Saline

PLACEBO COMPARATOR

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 2C has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 1: Grp 2E - PfSPZ Vaccine

EXPERIMENTAL

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=8; Two doses of 1.8 x 10\^6 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 2D has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 2E - Normal Saline

PLACEBO COMPARATOR

Children aged 13-59 months (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 2D has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 1: Grp 3A - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=8; Dose of 1.35 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2B has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 3A - Normal Saline

PLACEBO COMPARATOR

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 2B has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 3B - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=8; Dose of 2.7 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 3A has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 3B - Normal Saline

PLACEBO COMPARATOR

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 3A has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 3C - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=8; Dose of 4.5 x 10\^5 PfSPZ Vaccine administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 3B has been shown to be well-tolerated and without safety concerns.

Biological: PfSPZ Vaccine

Part 1: Grp 3C - Normal Saline

PLACEBO COMPARATOR

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=4; Normal saline administered DVI, as a single vaccination. This dose will be administered 2 weeks after Grp 3B has been shown to be well-tolerated and without safety concerns.

Other: Normal Saline

Part 1: Grp 3D - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=8; Two doses of 9.0 x 10\^5 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 3C has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 3D - Normal Saline

PLACEBO COMPARATOR

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 3C has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 1: Grp 3E - PfSPZ Vaccine

EXPERIMENTAL

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=8; Two doses of 1.8 x 10\^6 PfSPZ Vaccine administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 3D has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Biological: PfSPZ Vaccine

Part 1: Grp 3E - Normal Saline

PLACEBO COMPARATOR

Children aged 5-12 months (inclusive) of age will be enrolled in this group. N=4; Two doses of normal saline administered DVI, 8 weeks apart. The 1st dose will be administered 2 weeks after Grp 3D has been shown to be well-tolerated and without safety concerns. The 2nd dose will be administered 8 weeks after the 1st dose in this group does not show any safety signals.

Other: Normal Saline

Part 2: Group 1 - PfSPZ Vaccine

EXPERIMENTAL

Infants aged 5-12 months (inclusive) of age at vaccination will be enrolled in Part 2. N=104; the highest dose that is determined to be safe and well tolerated in the Part 1 trial, administered in 3 doses by DVI at 0, 8 and 16 weeks. Likely dosage will be 1.8 x 10\^6 PfSPZ per dose.

Biological: PfSPZ Vaccine

Part 2: Group 2 - PfSPZ Vaccine

EXPERIMENTAL

Infants aged 5-12 months (inclusive) of age at vaccination will be enrolled in Part 2. N=104; the second highest dose, which is half of the highest dose, administered in 3 doses by DVI at 0, 8 and 16 weeks. Likely dosage will be 9.0 x 10\^5 PfSPZ per dose.

Biological: PfSPZ Vaccine

Part 2: Group 3 - PfSPZ Vaccine

EXPERIMENTAL

Infants aged 5-12 months (inclusive) of age at vaccination will be enrolled in Part 2. N=104; a lower dose (half of the second highest dose) administered in 3 doses by DVI at 0, 8, 16 weeks. Likely dosage will be 4.5x 10\^5 PfSPZ per dose.

Biological: PfSPZ Vaccine

Part 2: Group 4 - Normal Saline

PLACEBO COMPARATOR

Infants aged 5-12 months (inclusive) of age at vaccination will be enrolled in Part 2. N=104; a placebo arm, will receive normal saline by DVI, 3 times at 8 week intervals.

Other: Normal Saline

Interventions

PfSPZ Vaccine BIOLOGICAL

Aseptic, purified, cryopreserved, radiation-attenuated Plasmodium falciparum sporozoites

Part 1: Grp 1A - PfSPZ Vaccine; Part 1: Grp 1B - PfSPZ Vaccine; Part 1: Grp 1C - PfSPZ Vaccine; Part 1: Grp 2A - PfSPZ Vaccine; Part 1: Grp 2B - PfSPZ Vaccine; Part 1: Grp 2C - PfSPZ Vaccine; Part 1: Grp 2D - PfSPZ Vaccine; Part 1: Grp 2E - PfSPZ Vaccine; Part 1: Grp 3A - PfSPZ Vaccine; Part 1: Grp 3B - PfSPZ Vaccine; Part 1: Grp 3C - PfSPZ Vaccine; Part 1: Grp 3D - PfSPZ Vaccine; Part 1: Grp 3E - PfSPZ Vaccine; Part 2: Group 1 - PfSPZ Vaccine; Part 2: Group 2 - PfSPZ Vaccine; Part 2: Group 3 - PfSPZ Vaccine

Normal Saline OTHER

0.9% Sodium chloride

Part 1: Grp 1A - Normal Saline; Part 1: Grp 1B - Normal Saline; Part 1: Grp 1C - Normal Saline; Part 1: Grp 2A - Normal Saline; Part 1: Grp 2B - Normal Saline; Part 1: Grp 2C - Normal Saline; Part 1: Grp 2D - Normal Saline; Part 1: Grp 2E - Normal Saline; Part 1: Grp 3A - Normal Saline; Part 1: Grp 3B - Normal Saline; Part 1: Grp 3C - Normal Saline; Part 1: Grp 3D - Normal Saline; Part 1: Grp 3E - Normal Saline; Part 2: Group 4 - Normal Saline

Eligibility Criteria

• Age: 5 Months - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children 5 months - 9 years inclusive (Part 1) and healthy infants 5-12 months inclusive (Part 2)
• HIV negative
• Able to participate for the duration of the study.
• Parents/guardians over the age of 18 years able and willing to provide informed consent/permission. The consent/permission will be in writing. For adult parents or guardians who are illiterate, an impartial witness can sign the consent/permission form on behalf of the parent and the parent/guardian will provide a thumb print.

You may not qualify if:

• Positive HIV test or breastfeeding infants or children of a known HIV positive mother (per Kenyan guidelines, these HIV exposed breastfeeding children should be on cotrimoxazole)
• Refusal of HIV testing
• Elevated ALT (liver function test) ≥2x ULN ( ALT \>84 U/L)
• Abnormal hematological parameters defined as: hemoglobin \< 8 g/dl, WBC \<1500 / mm3, neutrophils \<750/ mm3, platelet count \<75.000/ mm3
• Abnormal renal function test with creatinine \>0.9 mg/dL
• Known sickle cell disease and other inherited blood cell disorders like thalassemia and G6PD deficiency
• Current use of systemic immunosuppressant pharmacotherapy
• Current significant medical condition (cardiac, hepatic, renal, or hematological) or evidence of any other serious underlying medical condition identified by medical history, physical examination, or laboratory examination
• History of a splenectomy
• History of neurologic disorder (including seizures, other than uncomplicated febrile seizures)
• Known allergy to any component of the vaccine formulation, history of anaphylactic response to mosquito-bites, or known allergy to first or second line anti-malarials used to treat malaria
• Plan to participate in another investigational vaccine/drug research during or within 1 month of this study end
• Prior participation in a malaria vaccine trial
• Participation in the PfSPZ Vaccine Trial Part 1 (for Part 2 only)
• History of any other illness or condition which, in the investigator's judgment, may substantially increase the risk associated with the subject's participation in the protocol or compromise the scientific objectives

Sponsors & Collaborators

• Sanaria Inc.: lead
• Kenya Medical Research Institute: collaborator
• Centers for Disease Control and Prevention: collaborator
• National Institutes of Health (NIH): collaborator
• University of Maryland: collaborator

Study Sites (1)

Center for Global Health Research, KEMRI

Kisian, Siaya County, Kenya

Location

Related Publications (3)

• Oneko M, Steinhardt LC, Yego R, Wiegand RE, Swanson PA, Kc N, Akach D, Sang T, Gutman JR, Nzuu EL, Dungani A, Kim Lee Sim B, Oloo PN, Otieno K, Bii DK, Billingsley PF, James ER, Kariuki S, Samuels AM, Jongo S, Chebore W, Abdulla S, Daubenberger C, Mpina M, Styers D, Potter GE, Abarbanell G, Richie TL, Hoffman SL, Seder RA. Safety, immunogenicity and efficacy of PfSPZ Vaccine against malaria in infants in western Kenya: a double-blind, randomized, placebo-controlled phase 2 trial. Nat Med. 2021 Sep;27(9):1636-1645. doi: 10.1038/s41591-021-01470-y. Epub 2021 Sep 13.

  PMID: 34518679 DERIVED

• Oneko M, Cherop YR, Sang T, Gutman JR, Wiegand R, Nyang'au EM, Odila AD, Akach D, Hamel MJ, Samuels AM, Kariuki S, Abebe Y, Nzuu EL, Wijayalath W, James ER, Sim BKL, Billingsley PF, Richie TL, Hoffman SL, Seder RA, Steinhardt LC. Feasibility of direct venous inoculation of the radiation-attenuated Plasmodium falciparum whole sporozoite vaccine in children and infants in Siaya, western Kenya. Vaccine. 2020 Jun 15;38(29):4592-4600. doi: 10.1016/j.vaccine.2020.05.008. Epub 2020 May 19.

  PMID: 32444192 DERIVED

• Steinhardt LC, Richie TL, Yego R, Akach D, Hamel MJ, Gutman JR, Wiegand RE, Nzuu EL, Dungani A, Kc N, Murshedkar T, Church LWP, Sim BKL, Billingsley PF, James ER, Abebe Y, Kariuki S, Samuels AM, Otieno K, Sang T, Kachur SP, Styers D, Schlessman K, Abarbanell G, Hoffman SL, Seder RA, Oneko M. Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children: Findings From an Age De-escalation, Dose-Escalation, Double-blind, Randomized Controlled Study in Western Kenya. Clin Infect Dis. 2020 Aug 14;71(4):1063-1071. doi: 10.1093/cid/ciz925.

  PMID: 31555824 DERIVED

MeSH Terms

Conditions

Malaria; Malaria, Falciparum

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Martina Oneko, MD

  Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2016
• First Posted: February 22, 2016
• Study Start: July 21, 2016
• Primary Completion: August 1, 2018
• Study Completion: August 14, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Locations

KE (1)