Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
NCT ID: NCT00891007
Last Updated: 2012-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
90 participants
INTERVENTIONAL
2009-06-30
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group 1
MVA-mBN85B
Low Dose arm, 1x 10E7 TCID50
Group 2
MVA-mBN85B
Normal Dose arm, 1x 10E8 TCID50
Group 3
Rouvax
Standard measles vaccine, approved in South Africa
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MVA-mBN85B
Low Dose arm, 1x 10E7 TCID50
MVA-mBN85B
Normal Dose arm, 1x 10E8 TCID50
Rouvax
Standard measles vaccine, approved in South Africa
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female child between the age of 6 months to 6 years (Group C: 9 months to 6 years).
3. Prior or no prior measles vaccination indicated on the RTHC.
4. No known exposure to measles within 30 days prior to study entry.
5. No history of measles disease.
6. Negative human immunodeficiency virus antibody test (anti-HIV) and hepatitis B surface antigen (HBsAG).
7. Child is in good health as determined by medical history, physical examination and clinical judgment.
8. Children for whom the investigator reasonably believes its parents/guardian can and will comply with the requirements of the protocol
Exclusion Criteria
2. Severe malnutrition as assessed by the investigator by weight for age and clinical criteria.
3. History of splenectomy.
4. Clinically significant anaemia (laboratory and clinical criteria).
5. Having received any vaccinations or planned vaccinations with a live vaccine within 30 days prior to or after study vaccination.
6. Having received any vaccinations or planned vaccinations with a killed vaccine within 14 days prior to or after study vaccination.
7. 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.
8. 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.
9. History of any serious medical condition, which in the opinion of the investigator, would compromise the safety of the child.
10. History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded.
11. History of malignancy, especially leukaemia or lymphoma.
12. History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
13. History of anaphylaxis or severe allergic reaction.
14. Known allergy to egg proteins, gelatine, neomycin or gentamycin.
15. 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.
16. Previous participation in an MVA-based vaccination study
6 Months
6 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bavarian Nordic
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bavarian Nordic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chris Hani Baragwanath Hospital, Respiratory and Meningeal Pathogens Research Unit
Bertsham, , South Africa
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MEA-HFN-002
Identifier Type: -
Identifier Source: org_study_id