Phase 2
Completed N=540
Partially-blind (Observer-blind) Study of Safety and Immunogenicity of Two Malaria Vaccines in Ghanaian Children
Source: ClinicalTrials.gov NCT00360230 ↗Enrolled (actual)
540
Serious AEs
22.6%
Results posted
Feb 2018
Primary outcomePrimary: Number of Subjects With Serious Adverse Events (SAEs) — 10; 19; 5; 13 Participants
Summary
This study will investigate the safety and immunogenicity of 2 candidate malaria vaccines administered according to 3 different vaccination schedules in 5 to 17 months old Ghanaian children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Serious Adverse Events (SAEs) |
10; 19; 5; 13; 6; 17 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
61; 24; 23; 23; 14; 53 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
19; 14; 13; 14; 3; 21 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
78; 82; 40; 80; 41; 84 | — |
| SECONDARY Titers for Anti-Circumsporozoite Protein of Plasmodium Falciparum (Anti-CS) |
0.3; 0.3; 0.3; 0.3; 0.3; 0.3 | — |
| SECONDARY Titers for Anti-Hepatitis B (Anti-HBs) |
100.8; 107.6; 108.7; 82.1; 107.9; 88.1 | — |
Eligibility Criteria
Inclusion Criteria
- A male or female child 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.
- Proof that child has received a full 3-dose regimen of licensed Hepatitis B vaccine in infancy.
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 in the scope of the study) within 30 days of the first dose of vaccine(s) with the exception of tetanus toxoid or scheduled Yellow fever or Measles vaccine.
- Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of the 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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
- Simultaneous participation in any other clinical trial;
- Previous participation in any other malaria vaccine trial;
- Any twins
- 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 (NCT00360230). 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.