Phase 2
Completed N=894
Efficacy of RTS,S/AS01 Vaccine Against Episodes of Malaria Due to P. Falciparum Infection in Children.
Source: ClinicalTrials.gov NCT00380393 ↗Enrolled (actual)
894
Serious AEs
15.6%
Results posted
Jul 2018
Primary outcomePrimary: Frequency of First Case of Malaria Meeting the Primary Case Definition — 244.77; 238.51; 249.23; 242.06 PYAR — p=<0.001
Summary
This phase IIb trial is being done to find out if the RTS,S/AS01 vaccine helps to prevent children from falling ill with malaria and to evaluate vaccine safety.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of First Case of Malaria Meeting the Primary Case Definition |
244.77; 238.51; 249.23; 242.06 | <0.001 sig |
| SECONDARY Frequency of First Case Malaria Meeting the Secondary Case Definition |
244.72; 237.21; 249.17; 240.76 | <0.001 sig |
| SECONDARY Multiple Events of Malaria Meeting the Primary Case Definition |
253.69; 255.36; 258.15; 259.61 | 0.0003 sig |
| SECONDARY Multiple Events of Malaria Meeting the Secondary Case Definition |
253.62; 255.06; 258.07; 259.31 | <0.001 sig |
| SECONDARY Number of Subjects Positive for P. Falciparum Parasitaemia |
7; 11 | — |
| SECONDARY Geometric Mean Density of Asexual P. Falciparum Parasite |
1020; 3486 | — |
| SECONDARY Haemoglobin Values at Cross-Sectional Visit |
10.32; 10.37 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
51; 39; 0; 0; 20; 12 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
44; 28; 0; 0; 32; 27 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
349; 332 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
51; 88 | — |
| SECONDARY Number of Subjects With Hemoglobin Values Outside Normal Ranges With Toxicity Grades |
445; 446; 1; 1; 1; 0 | — |
| SECONDARY Number of Subjects With White Blood Cell (WBC) Values Outside Normal Ranges With Toxicity Grades |
447; 447; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Platelet Values Outside Normal Ranges With Toxicity Grades |
445; 447; 1; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Alanine Aminotransferase (ALT) Values Outside Normal Ranges With Toxicity Grades |
446; 447; 1; 0; 0; 0 | — |
| SECONDARY Number of Subjects With Creatinine Values Outside Normal Ranges With Toxicity Grades |
447; 447; 0; 0; 0; 0 | — |
| SECONDARY Concentration of Antibodies Against the P. Falciparum Circumsporozoite (CS) Repeat Domain (Anti-CS) |
0.3; 0.3; 539.6; 0.3; 71.9; 0.3 | — |
| SECONDARY Concentration of Antibodies Against Hepatitis B Surface Antigen (Anti-HBs) |
155.4; 187.4; 46776.3; 168.0 | — |
| SECONDARY Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells |
33; 13; 648; 139; 416; 172 | — |
| SECONDARY Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells |
36; 32; 248; 219; 201; 185 | — |
| SECONDARY Frequency of Cluster of Differentiation 4 (CD4+) CS-specific T-cells |
33; 13; 648; 139; 416; 172 | — |
| SECONDARY Frequency of Cluster of Differentiation 8 (CD8+) CS-specific T-cells |
36; 32; 248; 219; 201; 185 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female child of between 5 months and 17 months of age at the time of first vaccination.
- Written or oral, signed or thumb-printed and witnessed informed consent obtained from the parent(s)/guardian(s) of the child..
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
Exclusion Criteria
- Acute disease at the time of enrolment.
- Serious acute or chronic illness determined by clinical or physical examination and laboratory screening tests.
- Laboratory screening tests for haemoglobin, total white cell count, platelets, ALT and creatinine out of acceptable limits.
- Planned administration/administration of a vaccine not foreseen by the study within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled diphtheria, pertussis or measles vaccine.
- Use of any investigational or non-registered drug or vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Administration of immunoglobulins, blood transfusions or other blood products within the three months preceding the first dose of study vaccine or planned administration during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
- Previous participation in any other malaria vaccine trial.
- Simultaneous participation in any other clinical trial.
- Same sex twin.
- History of allergic reactions (significant IgE-mediated events) or anaphylaxis to previous immunizations.
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
- Any other findings that the investigator feels would increase the risk of having an adverse outcome from participation in the trial.
Data sourced from ClinicalTrials.gov (NCT00380393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.