MeaslesPhase 2NCT00891007
Study to Evaluate Safety, Dose Response and Immunogenicity of the Measles Vaccine MVA mBN85B in Healthy Children Aged 6 Months to 6 Years
A Phase 2 study testing MVA-mBN85B and Rouvax in people with Measles, run by Bavarian Nordic at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Measles
- What is being tested?
- MVA-mBN85B and Rouvax
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Africa
- Study dates
- Jun 2009to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Chris Hani Baragwanath Hospital, Respiratory and Meningeal Pathogens Research Unit
Bertsham, 2013
About this study
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
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.
Read the 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.
- Conditions
- Measles
- Being tested
- MVA-mBN85B, Rouvax
- Keywords
- Measles, Virus Disease, Paediatric Diseases, Paramyoxyviridae
- Medical subject headings
- Measles, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVA-mBN85BBiological
Low Dose arm, 1x 10E7 TCID50
MVA-mBN85BBiological
Normal Dose arm, 1x 10E8 TCID50
RouvaxBiological
Standard measles vaccine, approved in South Africa
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Not described Receives: Biological: MVA-mBN85B |
| Group 2 | Experimental | Not described Receives: Biological: MVA-mBN85B |
| Group 3 | Active comparator | Not described Receives: Biological: Rouvax |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJul 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeaslesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bavarian Nordic
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00891007
- Sponsor's protocol ID
- MEA-HFN-002
- Status last verified
- Jul 2012
- First submitted
- 29 Apr 2009
- Last updated
- 27 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00891007
- Acronym / sponsor ID
- MEA-HFN-002
- Conditions
- Measles
- Keywords
- Measles, Virus Disease, Paediatric Diseases, Paramyoxyviridae
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Bavarian NordicIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 30 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Biological: MVA-mBN85B |
| Group 2 | Experimental | Biological: MVA-mBN85B |
| Group 3 | Active comparator | Biological: Rouvax |
Who may qualify
- Ages
- 6 months to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVA-mBN85BLow Dose arm, 1x 10E7 TCID50 | Biological | Group 1 |
| MVA-mBN85BNormal Dose arm, 1x 10E8 TCID50 | Biological | Group 2 |
| RouvaxStandard measles vaccine, approved in South Africa | Biological | Group 3 |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MVA-mBN85B and Rouvax in people with Measles, run by Bavarian Nordic at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2012.