Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03162614 · ClinicalTrials.gov registry record · Phase 2
Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults
A Phase 2 study of Malaria, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 2
- Development phase
- 154
- Enrollment target
- 1
- Study location
NCT03162614: Completed Phase 2 study of Malaria, sponsored by GlaxoSmithKline.
NCT03162614 is a Phase 2 study of Malaria that has completed, run by GlaxoSmithKline. The registered enrollment target is 154 participants, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03162614, a Phase 2 study of Malaria, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 154 participants
- Enrollment target
- 1
- Study location
Study Summary
This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to investigate whether changes in dosing schedule are associated with increased or equivalent protection, and to evaluate the immune mechanisms associated with vaccine efficacy under varying dosing schedules.
Primary Outcome
Occurrence of P. falciparum parasitemia (defined by a positive blood slide) following sporozoite challenge. Post-challenge, parasitemia was determined by microscopy of Giemsa-stained thick blood films (smear). Microscopy was performed on thick smears using a validated standard operation procedure. For the analysis of proportion affected (relative risk), all subjects included in the analysis were considered at risk of infection and no censoring or elimination was applied for subjects not completi
Conditions Studied
Interventions
- BIOLOGICAL RTS,S/AS01E
- BIOLOGICAL RTS,S/AS01B
- PROCEDURE Sporozoite-infected mosquitoes challenge.
Study Locations (1)
Maryland
- GSK Investigational Site - Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 154 participants |
| Start Date | 2017-05-24 |
| Est. Completion | 2018-09-24 |
| Phase | Phase 2 |
What the finished NCT03162614 record still lists
NCT03162614 is an interventional study that assigns participants to a tested intervention. The registered 154 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 27 other Malaria trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Malaria appearing as the primary indexed condition, and to 3 interventions - of which RTS,S/AS01E is the first listed.
NCT03162614 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT03162614 about?
NCT03162614 is a clinical study titled "Efficacy, Immunogenicity and Safety Study of GSK Biologicals' Candidate Malaria Vaccine Evaluating Different Dose Schedules in a Sporozoite Challenge Model in Healthy Malaria-naïve Adults". This study is designed to evaluate efficacy, immunogenicity and safety of various dose schedules of GSK Biologicals' candidate malaria vaccines RTS,S/AS01B (adult formulation) and RTS,S/AS01E (pediatric formulation) in healthy malaria-naïve subjects aged 18-55 years. The purpose of this study is to ...
What is the current status of trial NCT03162614?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 154 participants. The study started on 2017-05-24. Estimated completion is 2018-09-24.
What conditions does trial NCT03162614 study?
This clinical trial studies the following conditions: Malaria.
What interventions are being tested in trial NCT03162614?
The interventions under investigation include: RTS,S/AS01E (BIOLOGICAL), RTS,S/AS01B (BIOLOGICAL), Sporozoite-infected mosquitoes challenge. (PROCEDURE).
Who is sponsoring clinical trial NCT03162614?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03162614 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Malaria
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03162614's enrollment target sits among peer trials
154 8th of 27 higher than 19 of 27 other Malaria trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Malaria trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Weekly Dosing of Malarone ® for Prevention of Malaria
COMPLETED · Phase 2
-
Safety, Immunogenicity and Efficacy Against of a Combined Malaria Vaccine in Healthy Malaria-naïve Adults
COMPLETED · Phase 2
-
Screening of Healthy Volunteers for Investigational Antimalarial Drugs, Malaria Vaccines, and Controlled Human Malaria Challenge
RECRUITING
-
Observational Study of the Safety of Intravenous Artesunate Treatment of Pregnant Women and Their Infants
RECRUITING
-
Evaluation, Treatment and Monitoring of Patients With a Known or Suspected Parasitic Infection
RECRUITING
-
A Study of Oral E1018 in Healthy Adult Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04300998 · 154 participants
Study of CAR-T Therapy in Older Patients
- NCT04597372 · 154 participants · Phase 2
Impact of Tamsulosin on Post-Operative Urinary Retention Following Pelvic Reconstructive Surgery
- NCT05294042 · 154 participants · NA
Patient Navigators for Children's Community Mental Health Services in High Poverty Urban Communities
- NCT05512390 · 154 participants · Phase 1
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI