Prevention of smallpox infection in children MedDRA version: 14.1 Level: PT Classification code 10041197 Term: Smallpox System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: IMVANEX
Product Code: MVA-BN
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Live Modified Vaccinia Virus Ankara
Other descriptive name: MODIFIED VACCINIA ANKARA – BAV
Sponsors
Bavarian Nordic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Children from birth to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any clinically significant condition which in the opinion of the investigator would compromise the safety of the subject, i.e. the risk would outweigh the benefit of receiving the vaccine (i.e. any uncontrolled serious infection, i.e. not responding to antimicrobial therapy; known or suspected impairment of immunologic function; acute disease with or without pyrexia; temperature more than or equal to 38.0°C [more than or equal to100.4°F]; post organ transplant subjects whether or not receiving chronic immunosuppressive therapy; any other history or clinical manifestation of clinically significant haematological, pulmonary, central nervous, cardiovascular or gastrointestinal disorders). 2. 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 trial conclusion. 3. History of or currently active autoimmune disease. Children with vitiligo or thyroid disease on thyroid replacement therapy are not excluded. 4. History of malignancy, especially leukaemia or lymphoma. 5. History of allergic disease or hypersensitivity likely to be exacerbated by any component of the vaccine. 6. History of anaphylaxis or severe allergic reaction. 7. Chronic administration (defined as more than 14 days) of systemic high dose immune-suppressant drugs during a period starting from six months prior to administration of vaccine and ending at trial 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. 8. Use of any investigational or non-registered drug or vaccine other than the trial vaccine within 30 days preceding the first dose of the study vaccine, or planned administration of such a drug during the trial period.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the immunogenicity after two doses of MVA-BN® smallpox vaccine in children/infants and toddlers.;Secondary Objective: To assess the safety and reactogenicity of MVA-BN® smallpox vaccine in children/infants and toddlers. To assess the immunogenicity in infants/children and toddlers after one compared to two doses of MVA-BN® smallpox vaccine ;Primary end point(s): Geometric Mean Titer (GMT) measured by vaccinia-specific Enzyme-linked Immunosorbent Assay (ELISA) and Plaque Reduction Neutralization Test (PRNT) at Visit 5 i.e. 4 weeks after the second vaccination;Timepoint(s) of evaluation of this end point: 4 weeks after the second vaccination | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety • Occurrence, relationship and intensity of any serious adverse events up to Day 56.Occurrence of any Grade 3 adverse events related to the trial vaccine within 28 days after any vaccination. • Occurrence, relationship to the trial vaccine and intensity of unsolicited non-serious Adverse Events (AEs) within 28 days after each vaccination. • Occurrence, intensity and duration of solicited local AEs (redness, swelling, induration, pruritus and pain) during the 8-day period (day of vaccination and the following 7 days) after each vaccination. • Occurrence, relationship to the trial vaccine, intensity and duration of solicited general AEs (pyrexia, headache, myalgia, nausea, fatigue and chills) during the 8-day period (day of vaccination and the following 7 days) after each vaccination. • Occurrence of smallpox disease in subjects. Immunogenicity • Seroconversion rates as determined by vaccinia-specific ELISA at Visit 3 and Visit 5, i.e. four weeks after the first and second vaccination respectively. • Seroconversion rates as determined by vaccinia-specific PRNT at Visit 3 and Visit 5, i.e. four weeks after the first and second vaccination respectively. • GMT calculated from individual vaccinia-specific ELISA titers at Baseline (Visit 1) and Visit 3 (four weeks after the first vaccination). • GMT calculated from individual vaccinia-specific PRNT titers at Baseline (Visit 1) and Visit 3 (four weeks after the first vaccination). ;Timepoint(s) of evaluation of this end point: see above | — |
Countries
Germany
Contacts
Public ContactClinical Trials Information
Bavarian Nordic GmbH
Outcome results
None listed