Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years

Open label study to assess the safety and immunogenicity of MVA-mBN85B in healthy vaccine-naive, measles-naive and measles-experienced children. The study is comprised of three groups with 30 children each. Two groups will receive two subcutaneous (s.c.) immunizations 4 weeks (28±3 days) apart of either either 1 x 10E7 TCID50 (Group A) or 1 x 10E8 TCID50 (Group B) MVA mBN85B. The control group (Group C) will receive two s.c. doses (0.5 ml, 1000 TCID50) of Rouvax® (Sanofi-Pasteur) 24 weeks apart.

Inclusion criteria

• Read, signed and dated informed consent document from one parent/guardian of the child after being advised of the risks and benefits of the study in a language understood by the parent/guardian. This document must be signed prior to performance of any study specific procedure.
• Male or female child between the age of 6 months to 6 years (Group C: 9 months to 6 years).
• Prior or no prior measles vaccination indicated on the RTHC.
• No known exposure to measles within 30 days prior to study entry.
• No history of measles disease.
• Negative human immunodeficiency virus antibody test (anti-HIV) and hepatitis B surface antigen (HBsAG).
• Child is in good health as determined by medical history, physical examination and clinical judgment.
• Children for whom the investigator reasonably believes its parents/guardian can and will comply with the requirements of the protocol

Exclusion criteria

• Any clinically significant condition that may influence participation in this study, including febrile convulsions.
• Severe malnutrition as assessed by the investigator by weight for age and clinical criteria.
• History of splenectomy.
• Clinically significant anaemia (laboratory and clinical criteria).
• Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after study vaccination.
• Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after study vaccination.
• Administration or planned administration of immunoglobulins and/or any blood products during a period starting from 3 months prior to administration of the vaccine and ending at study conclusion.
• Use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the study period.
• History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the child.
• History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
• History of malignancy, especially leukaemia or lymphoma.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• History of anaphylaxis or severe allergic reaction.
• Known allergy to egg proteins, gelatine, neomycin or gentamycin.
• Chronic administration (defined as more than 14 days) of systemic high dose immuno-suppressant drugs during a period starting from six months prior to administration of the vaccine and ending at study conclusion. High dose is defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weigh more than 10 kg.
• Previous participation in an MVA-based vaccination study