Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Measles |
Biological: MVA-mBN85B Biological: Rouvax |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Partially Randomized, Controlled Phase II Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years |
| Enrollment: | 90 |
| Study Start Date: | June 2009 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Group 1 |
Biological: MVA-mBN85B
Low Dose arm, 1x 10E7 TCID50
|
| Experimental: Group 2 |
Biological: MVA-mBN85B
Normal Dose arm, 1x 10E8 TCID50
|
| Active Comparator: Group 3 |
Biological: Rouvax
Standard measles vaccine, approved in South Africa
|
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 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.
Eligibility| Ages Eligible for Study: | 6 Months to 6 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Monika Fluer, Bavarian Nordic |
| ClinicalTrials.gov Identifier: | NCT00891007 History of Changes |
| Other Study ID Numbers: | MEA-HFN-002 |
| Study First Received: | April 29, 2009 |
| Last Updated: | July 26, 2012 |
| Health Authority: | South Africa: Medicines Control Council |
Keywords provided by Bavarian Nordic:
|
Measles Virus Disease Paediatric Diseases Paramyoxyviridae |
Additional relevant MeSH terms:
|
Measles Morbillivirus Infections Paramyxoviridae Infections |
Mononegavirales Infections RNA Virus Infections Virus Diseases |
ClinicalTrials.gov processed this record on May 19, 2013