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

NCT00891007 | Completed Phase 2

• 1 other identifier: MEA-HFN-002
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Measles

Keywords

Measles; Virus Disease; Paediatric Diseases; Paramyoxyviridae

Study Arms (3)

Group 1

EXPERIMENTAL

Biological: MVA-mBN85B

Group 2

EXPERIMENTAL

Biological: MVA-mBN85B

Group 3

ACTIVE COMPARATOR

Biological: Rouvax

Interventions

MVA-mBN85B BIOLOGICAL

Low Dose arm, 1x 10E7 TCID50

Group 1

Rouvax BIOLOGICAL

Standard measles vaccine, approved in South Africa

Group 3

Eligibility Criteria

• Age: 6 Months - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bavarian Nordic: lead

Study Sites (1)

Chris Hani Baragwanath Hospital, Respiratory and Meningeal Pathogens Research Unit

Bertsham, 2013, South Africa

Location

MeSH Terms

Conditions

Measles; Virus Diseases

Condition Hierarchy (Ancestors)

Morbillivirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 29, 2009
• First Posted: April 30, 2009
• Study Start: June 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2010
• Last Updated: July 27, 2012

Record last verified: 2012-07

Locations

ZA (1)