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Safety and Immunogenicity of 30 and 100 µg of GMZ2 in Gabonese Children Aged 1-5 Years

NCT00703066 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2008-11-25

No results posted yet for this study

Summary

The study aims to show that the candidate malaria vaccine GMZ2 is as safe as the already publicly used vaccine against rabies. 30 Gabonese children aged 1-5 years will be enrolled and randomly allocated to receive either malaria vaccine or rabies vaccine without the investigator or the participants knowing what they received. They will receive 3 doses each at one month intervals, and will be followed up for one year to evaluate safety parameters. 30 and 100µg doses for the candidate malaria vaccine GMZ 2 will be evaluated for safety.

This is the second time that candidate malaria vaccine GMZ 2 is being tested in Africa, the first time being in Gabonese adults where the product was found to be safe.

Conditions

Interventions

BIOLOGICAL

GMZ 2 vaccine (GLURP + MSP 3)

three doses of 30µg of GMZ 2 vaccine,

BIOLOGICAL

GMZ 2 vaccine (GLURP + MSP 3)

100 µg of GMZ 2 vaccine

BIOLOGICAL

Rabies vaccine

3 doses of Rabies vaccine

Sponsors & Collaborators

  • African Malaria Network Trust

    lead NETWORK

Principal Investigators

  • Peter Kremsner, MD, PhD · Medical research Unit, Albert Schweitzer Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-07-31
Completion
2009-08-31

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 NCT00703066 on ClinicalTrials.gov