Who is sponsoring NCT01412801?

NCT01412801 is sponsored by Novartis Vaccines.

What condition does NCT01412801 study?

NCT01412801 studies Streptococcal Infections, Gram-Positive Bacterial Infections, Bacterial Infections.

What drugs are being tested in NCT01412801?

Interventions: Group B streptococcus vaccine.

What is the status of NCT01412801?

NCT01412801 is currently COMPLETED.

Last reviewed 2014-09-05 · How we verify

A Phase II Open-Label, Multi-Center Study of a Group B Streptococcus Vaccine in HIV Positive and HIV Negative Pregnant Women

NCT01412801 Phase 2 COMPLETED Results posted

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 the maternal to fetal transfer of antibodies induced by the investigational vaccine.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 2
Status	COMPLETED
Enrolment	270
Start date	2011-09
Completion	2012-12

Conditions

Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

Interventions

Group B streptococcus vaccine

Primary outcomes

Geometric Mean Concentrations (GMCs) of Antibodies in Maternal Subjects and Infants at Delivery/Birth — Day of delivery/birth
GMCs of Group B Streptococcus (GBS)-specific Abs against serotypes Ia, Ib and III in mothers and in infants at delivery/birth are presented.
Geometric Mean Antibody Transfer Ratio Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL), for GBS Serotypes Ia, Ib and III at Delivery/Birth. — Day of delivery/birth
The Geometric mean transfer ratio of GBS-specific Ab against serotypes Ia, Ib and III at delivery is calculated as the geometric mean of the pairwise ratios between the antibody concentrations from infant at birth and to maternal serum concentration at delivery.

Countries

Malawi, South Africa