NCT00891007

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Bavarian Nordic · Industry
• Sex: All
• Age: 6 Months – 6 Years
• Healthy volunteers: Accepted

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 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

Interventions

Type	Name	Description
BIOLOGICAL	MVA-mBN85B	Low Dose arm, 1x 10E7 TCID50
BIOLOGICAL	MVA-mBN85B	Normal Dose arm, 1x 10E8 TCID50
BIOLOGICAL	Rouvax	Standard measles vaccine, approved in South Africa

Timeline

• Start date: 2009-06-01
• Primary completion: 2010-07-01
• Completion: 2010-08-01
• First posted: 2009-04-30
• Last updated: 2012-07-27

Locations

1 site across 1 country: South Africa