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Safety, Tolerability and Protective Efficacy of PfSPZ Vaccine in Gabonese Children

NCT03521973 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-10-07

No results posted yet for this study

Summary

This study is a single site, randomized, double-blind, placebo-controlled trial. The trial will assess the safety, tolerability, immunogenicity and vaccine efficacy (VE) of PfSPZ Vaccine in Gabonese children that are naturally exposed to malaria parasites. Healthy children aged 1- 12 years living in the surrounding areas of Lambaréné and/or Fougamou Province in Gabon will be eligible for participation.

Conditions

Interventions

BIOLOGICAL

PfSPZ Vaccine

Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

OTHER

Normal Saline

0.9% Sodium chloride

Sponsors & Collaborators

  • Centre de Recherches Médicales de Lambaréné (CERMEL), German Center for Infection Research

    collaborator UNKNOWN

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Selidji Agnandji, MD · Centre de Recherches Médicales de Lambaréné (CERMEL)

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
12 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-14
Primary Completion
2021-05-18
Completion
2021-08-03
FDA Drug
Yes

Countries

  • Gabon

Study Locations

More Related Trials

Entities

Diseases

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 NCT03521973 on ClinicalTrials.gov