Phase II multi-centre study to evaluate efficacy, safety, and immunogenicity of GMZ2 candidate malaria vaccine in children aged 12 to 60 months
- Conditions
- MalariaPaediatrics
- Registration Number
- PACTR2010060002033537
- Lead Sponsor
- Statens Serum Intitute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 1840
1.Children aged 12 - 60 months inclusive at the time of the first dose
2.Healthy by medical history and physical examination
3.Signed or thumb-printed Informed Consent by guardian/parent. Where guardian/parent cannot sign, a witness will be asked to sign to indicate that the procedures were understood and consent was given.
4.Resident in the study villages during the whole clinical trial period
1.Symptoms, physical signs of disease that could interfere with the interpretation of the clinical trial results or compromise the health of the subjects if they were vaccinated
2.Immunosuppressive therapy (steroids, immune modulators or immune suppressors) within three (3) months prior recruitment. (for corticosteroids, this will mean prednisone, or equivalent, ¿ 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
3.Cannot be followed for any social, psychological or geographical reasons.
4.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 the end of the child¿s participation in this clinical trial.
5.Suspected or known hypersensitivity to any of the vaccine components or to any vaccine.
6.Acute or chronic, clinically significant hepatic or renal functional abnormality.
7.Anaemia associated with clinical signs or symptoms of decompensation or haemoglobin < 7.0 g/dL.
8.Planned administration of a vaccine not foreseen by the trial protocol within 30 days of 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
9.Presence of chronic illness that, in the judgement of the investigator, would interfere with the study outcomes or pose a threat to the participant¿s health.
10.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
11.History of surgical splenectomy.
12.Severe malnutrition at screening defined as weight for age Z-score less than 3
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy
- Secondary Outcome Measures
Name Time Method Efficacy on anemia and severe anemia;safety and reactogenicity;Efficacy on clinical malaria by other case definitions;EXPLORATORY: Humoral and cellular responses;EXPLORATORY: Functionality of immune responses;EXPLORATORY: Effect of other infections on immune response and vaccine efficacy;EXPLORATORY: Assess changes in parasite population;EXPLORATORY: Investigate evidence for waning of efficacy