Status:
COMPLETED
Magnitude of the Antibody Response to and Safety of a GBS Trivalent Vaccine in HIV Positive and HIV Negative Pregnant Women and Their Offsprings
Lead Sponsor:
Novartis Vaccines
Conditions:
Streptococcal Infections
Gram-Positive Bacterial Infections
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief Summary
The study compared the magnitude of the antibody response and safety of a GBS Trivalent Vaccine in HIV positive and HIV negative pregnant women and their offspring. In addition the study investigated ...
Eligibility Criteria
Inclusion
- Pregnant women 18-40 years of age between 24-35 weeks gestation
- Women who were HIVneg or HIVpos with WHO stage I or II disease and with CD4+ counts \> 50 cells/µL
Exclusion
- Women who had CD4+ count ≤ 50 cells/µL
- Women who were HIVpos with WHO stage III or IV disease, history of severe allergic reactions after previous vaccinations
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
270 Patients enrolled
Trial Details
Trial ID
NCT01412801
Start Date
September 1 2011
End Date
December 1 2012
Last Update
September 12 2014
Active Locations (2)
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1
Limbe Health Center
Blantyre, Malawi
2
Chris Hani Baragwanath Hospital
Bertsham, South Africa, 2013