Status:
UNKNOWN
Immunogenicity, Efficacy and Safety Study of an MSP3-LSP (Long Synthetic Peptide) Malaria Vaccine
Lead Sponsor:
African Malaria Network Trust
Conditions:
Malaria
Eligibility:
All Genders
12-48 years
Phase:
PHASE2
Brief Summary
This study will be the fourth time that the candidate malaria vaccine Merozoite Surface Protein - long synthetic chain, will be tested in malaria endemic populations.in the past,once tested in adults ...
Detailed Description
This will be a double blind, randomized, placebo-controlled phase IIb study to evaluate the immunogenicity, efficacy and safety of Plasmodium falciparum vaccine candidate, Merozoite Surface Protein-3 ...
Eligibility Criteria
Inclusion
- Children aged 12-48 months old
- Healthy by medical history, physical examination and laboratory investigation
- Signed/thumb printed informed Consent by guardian/parent
- Resident in the study area villages during the whole trial period
Exclusion
- Symptoms, physical signs of disease that could interfere with the interpretation of the trial results or compromising the health of the subjects
- Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within 3 months prior recruitment. (Inhaled and topical steroids are allowed).
- Cannot be followed for any social, psychological or geographical reasons.
- Use of any investigational drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use up to 30 days after the third dose.
- Suspected or known hypersensitivity to any of the vaccine components or to previous vaccine.
- Laboratory abnormalities on screened blood samples.
- Planned administration of a vaccine not foreseen by the study protocol within 30 days before the first dose of vaccine. An exception, is the receipt of an EPI or licensed vaccine (measles, oral polio, Hib, meningococcal and combined diphtheria/pertussis/tetanus vaccines) which may be given 14 days or more before or after vaccination
- Evidence of chronic or active hepatitis B or C infection
- Presence of chronic illness that, in the judgment of the investigator, would interfere with the study outcomes or pose a threat to the participant's health.
- Administration of immunoglobulin and/or any blood products within the three months preceding the first dose of study vaccine or planned administration during the study period
- History of surgical splenectomy.
- Moderate or severe malnutrition at screening defined as weight for age Z-score less than 2
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2010
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT00652275
Start Date
May 1 2008
End Date
December 1 2010
Last Update
May 7 2008
Active Locations (1)
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1
Malaria Research Training Center
Bamako, Mali, BP 1805,point G