Status:
COMPLETED
A Study of MVA85A in Healthy Infants
Lead Sponsor:
Aeras
Collaborating Sponsors:
University of Oxford
University of Cape Town
Conditions:
Tuberculosis
Eligibility:
All Genders
126-182 years
Phase:
PHASE2
Brief Summary
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in Bacillus Calmette-Guérin (BCG) vaccinated infants without tuberculosis...
Detailed Description
This was a Phase II double-blinded randomized controlled evaluation of safety, immunogenicity and efficacy of MVA85A/AERAS-485 in BCG vaccinated infants without tuberculosis or HIV infection. Infants ...
Eligibility Criteria
Inclusion
- Age of 126 through 182 days on the day of randomization (Study Day 0)
- Written informed consent obtained from the parents/guardian
- Weight: by chart \>3rd percentile on Study Day 0 or, if \< 3rd percentile, infant has shown a stable growth pattern
- BCG vaccination within 7 days of birth
- Generally good health confirmed by medical history and physical examination within 35 days prior to Study Day 0
- Must have received age-appropriate doses of pneumococcal vaccine as recommended by the South African Department of Health but no injection within 14 day prior to Study Day 0
- Ability to complete follow-up period as required by the protocol
- Completed simultaneous enrollment in the Aeras Vaccine Development Registry protocol
Exclusion
- Acute illness on Study Day 0
- Fever \>=37.5 degrees Celsius on Study Day 0
- Evidence of significant active infection on Study Day 0
- Received a Expanded Program of Immunization (EPI) within 14 days prior to Study Day 0
- Historical or virological evidence of individual or maternal human immunodeficiency virus (HIV-1) infection
- History of allergic disease or reactions likely to be exacerbated by any component of the study vaccine
- Previous medical history, or evidence, of an intercurrent illness that may compromise the safety of the infant in the study
- Evidence of chronic hepatitis from any cause
- History or evidence of any systemic disease on physical examination or any acute, chronic or intercurrent illness that, in the opinion of the investigator, may interfere with the evaluation of the safety or immunogenicity of the vaccine
- History of or known tuberculosis or treatment for tuberculosis
- Shared residence since birth with an individual with active tuberculosis or on anti-tuberculosis treatment for less than 2 months
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
2797 Patients enrolled
Trial Details
Trial ID
NCT00953927
Start Date
July 1 2009
Last Update
May 24 2016
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
South African Tuberculosis Vaccine Initiative (Satellite)
Ceres, South Africa, 6835
2
South African Tuberculosis Vaccine Initiative (Satellite)
Robertson, South Africa, 6705
3
South African Tuberculosis Vaccine Initiative (Headquarters)
Worcester, South Africa, 6850