Status:
COMPLETED
Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
Lead Sponsor:
Bavarian Nordic
Conditions:
Measles
Eligibility:
All Genders
6-6 years
Phase:
PHASE2
Brief Summary
Partially randomized, controlled Phase II study to evaluate safety, immunogenicity and dose response of the measles vaccine MVA mBN85B in healthy children aged 6 months to 6 years.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00891007
Start Date
June 1 2009
End Date
August 1 2010
Last Update
July 27 2012
Active Locations (1)
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1
Chris Hani Baragwanath Hospital, Respiratory and Meningeal Pathogens Research Unit
Bertsham, South Africa, 2013