Status:
COMPLETED
Study of AERAS-402 in Healthy Infants
Lead Sponsor:
Aeras
Collaborating Sponsors:
European and Developing Countries Clinical Trials Partnership (EDCTP)
Conditions:
Tuberculosis
Eligibility:
All Genders
112-182 years
Phase:
PHASE1
PHASE2
Brief Summary
AERAS-402 will be given to infants of at least 16 weeks of age who have already been vaccinated with BCG to determine if AERAS-402 will increase protection of infants to tuberculosis.
Detailed Description
The only currently available tuberculosis vaccine, bacillus Calmette-Guérin (BCG), is estimated to reduce the risk of tuberculosis (TB) in children by up to 70-80%, but protection is incomplete. Effor...
Eligibility Criteria
Inclusion
- Parent/legal guardian has completed the written informed consent process
- Is age greater than or equal to 112 days (16 weeks) and less than or equal 182 days (26 weeks) on Study Day 0
- Has general good health, confirmed by medical history and physical examination
- Is up to date on all Expanded Program of Immunization (EPI) immunizations for his/her age with a minimum of 14 days between the last EPI vaccination and administration of study vaccine on Study Day 0
- Has ability to complete follow-up period of 728 days as required by the protocol
- Parent/legal guardian is able and willing to stay in contact with the study site for the duration of the study and to provide updated contact information as necessary, and has no current plans to move from the study area for the duration of the study
- Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol
- Had BCG vaccination ≥ 3 months prior to randomization documented by medical card
Exclusion
- Acute illness, evidence of any significant active infection or temperature \>=37.5°C on the day of randomization
- Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted)
- Received immunoglobulin or blood products within 45 days before entry into the study
- Ever received any investigational drug therapy or investigational vaccine
- History or laboratory evidence of individual immunodeficiency virus (HIV-1) infection
- History of allergic disease or reactions to any component of the study vaccine
- Previous medical history that may compromise the safety of the participant in the study
- Evidence of a new acute illness that may compromise the safety of the participant in the study
- Inability to discontinue daily medications during the study
- History or evidence of any systemic disease on physical examination or any acute or chronic illness that may interfere with the evaluation of the safety or immunogenicity of the vaccine, e.g., including masses between the leg and abdomen (e.g., inguinal hernia or lymphadenopathy)
- History or evidence of active tuberculosis
- A positive QuantiFERON®-TB Gold In-Tube test
- A household contact with active TB disease
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2014
Estimated Enrollment :
487 Patients enrolled
Trial Details
Trial ID
NCT01198366
Start Date
September 1 2010
End Date
April 1 2014
Last Update
May 8 2017
Active Locations (7)
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1
Boro Heath Center
Boro, Kenya
2
KEMRI/CDC Research and Public Heath Collaboration
Kisumu, Kenya, 40100
3
Siaya District Hospital
Siaya, Kenya
4
CISM: Centro de Investigacao em Saude de Manhica
Manhiça, Mozambique, 1929