a study to evaluate the safety and immunogenicity of a candidate ebola vaccine in children

Conditions: Virus Diseases

Summary: the purpose of this study is to assess the safety and reactogenicity of a single im dose of the gsk3390107a (chad3 ebo-z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. considering the risk of exposure to ebola and the potential (based on animal data) for the investigational gsk3390107a (chad3-ebo-z) vaccine to afford at least partial protection, all children in the study will receive the investigational gsk3390107a (chad3 ebo-z) vaccine. the children in the group gsk3390107a+nimenrix will receive the investigational gsk3390107a (chad3-ebo-z) vaccine at day 0 of the study, whereas the children in the group nimenrix+gsk3390107a will receive nimenrix at day 0 (as a control). at month 6, the children in the group nimenrix+gsk3390107a will receive the investigational gsk3390107a (chad3-ebo-z) vaccine (provided that no safety concerns are raised), whereas the children in the group gsk3390107a+nimenrix will receive nimenrix.


Eligibility criteria:
inclusion criteria: * subject's parent(s)/ legally acceptable representative(s) (lar\[s\]) who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g. availability for diary card completion, return for follow-up visits, availability for clinical follow-up throughout the study period). * written/ thumb printed informed consent obtained from the subject' parent(s)/ lar\[s\] prior to performing any study specific procedure. in addition, written/ thumb printed in-formed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements). * a male or female child aged 1 to 17 years inclusive at the time of screening. * subjects with a negative rdt test for malaria within 30 days prior to randomisation into the study. or subjects with a positive rdt test for malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study. * healthy subjects as per investigator judgement, as estab-lished by medical history, clinical examination and haema-tology/ biochemistry laboratory parameters screening be-fore entering into the study. * female subjects of non-childbearing potential may be enrolled in the study. * non-childbearing potential is defined as pre-menarche or ovariectomy. * female subjects of childbearing potential may be enrolled in the study, if the subject: * has practiced adequate contraception for 30 days prior to the day 0 visit, and * has a negative pregnancy test at the day 0 visit, and * has agreed to continue adequate contraception until 30 days after the month 6 visit exclusion criteria: * child in care. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the day 0 visit, or planned use during the study period. * previous vaccination with an investigational ebov or marburg vaccine, or previous vaccination with a chim-panzee adenoviral vectored investigational vaccine. * known prior ebov or sudv disease. * travel to country affected by the ebov epidemic or direct contact with person with evd within 21 days prior to the day 0 visit. * history of any reaction or hypersensitivity (such as ana-phylaxis, urticaria (hives), respiratory difficulty, angioe-dema, or abdominal pain) likely to be exacerbated by any component of the study vaccine. * planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit. * acute or chronic illness determined by medical history, clinical examination and laboratory screening tests in-cluding, but not limited to: * clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome \[aids\]). * major congenital defects. * malnutrition (defined as weight for age z-score less than -3, or other clinical signs of malnutrition). * any clinically significant haematological or biochemical laboratory abnormality. * pregnant female. * any condition that in the investigator's opinion may po-tentially compromise subject safety or interfere with sub-ject assessment or compliance.

Keywords: protection against ebola zaire virus