Phase II, AERAS-402 in BCG Vaccinated Infants
- Conditions
- TuberculosisPaediatrics
- Registration Number
- PACTR201203000306280
- Lead Sponsor
- Aeras
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 4192
Subjects must meet all of the following criteria at the time of subject ID assignment:
1. Parent/legal guardian has completed the written informed consent process
2. Is age ¿112 days (16 weeks) and ¿182 days (26 weeks) on Study Day 0
3. Has general good health, confirmed by medical history and physical examination
4. Is up to date on all 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
5. Known HIV status of subject's biological mother, as determined at screening unless there is prior written documentation of maternal HIV infection, or written documentation of a negative HIV test result on a sample obtained from the mother within 28 days prior to their
baby's enrollment; HIV-infected women who are breastfeeding an infant enrolled in the study must be on HAART
6. Has ability to complete follow-up period as required by the protocol
7. 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
8. Has completed simultaneous enrollment in Aeras Vaccine Development Registry protocol
9. Had BCG vaccination ¿ 3 months prior to randomization documented by medical card
Subjects must have none of the following at the time of subject ID assignment:
1. Acute illness, evidence of any significant active infection or temperature ¿37.5°C on the day of randomization
2. Used immunosuppressive medication within 45 days before entry into the study (inhaled and topical corticosteroids are permitted)
3. Received immunoglobulin or blood products within 45 days before entry into the study
4. Ever received any investigational drug therapy or investigational vaccine
5. History or laboratory evidence of human immunodeficiency virus (HIV) infection
6. History of allergic disease or reactions to any component of the study vaccine
7. Previous medical history that may compromise the safety of the participant in the study
8. Evidence of a new acute illness that may compromise the safety of the participant in the study
9.Inability to discontinue daily medications during the study, except for breastfeeding HIV-exposed infants who will be allowed to continue on cotrimoxazole prophylaxis during the study.
10.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)
11. History or evidence of active tuberculosis
12. A positive or indeterminate QuantiFERON®¿TB Gold In-Tube test on Study Day 0
13. A household contact with active TB disease
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tb Disease
- Secondary Outcome Measures
Name Time Method