Who is sponsoring NCT01193920?

NCT01193920 is sponsored by Novartis Vaccines.

What condition does NCT01193920 study?

NCT01193920 studies Streptococcal Infections.

What drugs are being tested in NCT01193920?

Interventions: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg, Saline solution, Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg, Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg, Group B Streptococcus Trivalent Vaccine - 5/5/5 μg, saline solution.

What is the status of NCT01193920?

NCT01193920 is currently COMPLETED.

Last reviewed 2014-08-18 · How we verify

A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa

NCT01193920 Phase 1/Phase 2 COMPLETED Results posted

This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 1/Phase 2
Status	COMPLETED
Enrolment	380
Start date	2010-10
Completion	2012-12

Conditions

Streptococcal Infections

Interventions

Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Saline solution
Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
saline solution

Primary outcomes

The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. — Day 61, one month after the second vaccination
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. — Day 61, one month after the second vaccination
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. — Day of delivery
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Antibody GMC in Maternal Subjects at Day of Delivery — Day of delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.

Countries

South Africa