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

NCT02687373 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 337

Last updated 2019-04-19

No results posted yet for this study

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

Interventions

BIOLOGICAL

PfSPZ Vaccine

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

OTHER

Normal Saline

0.9% Sodium chloride

Sponsors & Collaborators

  • Kenya Medical Research Institute

    collaborator OTHER

  • Centers for Disease Control and Prevention

    collaborator FED

  • National Institutes of Health (NIH)

    collaborator NIH

  • University of Maryland

    collaborator OTHER

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Martina Oneko, MD · Kenya Medical Research Institute, Centre for Global Health Research, Kisumu, Kenya

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Months
Max Age
9 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-07-21
Primary Completion
2018-08-31
Completion
2018-08-14

Countries

  • Kenya

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02687373 on ClinicalTrials.gov