NCT01446289View on ClinicalTrials.gov

Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

PHASE2CompletedINTERVENTIONAL
Enrollment

86

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

April 30, 2013

Study Completion Date

October 31, 2013

Conditions
Streptococcal InfectionGram-positive Bacterial InfectionBacterial Infection
Interventions
BIOLOGICAL

Group B Streptococcus Trivalent Vaccine

Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.

BIOLOGICAL

Placebo

Pregnant women who received one injection of saline solution administered intramuscularly.

Trial Locations (5)

3300

Regionaal Ziekenhuis Heilig Hart,, Gasthuismolenstraat 31

49-B-3000

UZ Leuven, Herestraat

V6H3N1

University of British Columbia, Rm B3 25 B, 4500 Oak Street,, Vancouver

B3K 6R8

Dalhousie University, IWK Health Centre, 5850/5980 University Avenue,, Halifax

G1V 4G2

Centre hospitalier universitaire de Quebec (CHUQ)- hospital CHUL, Centre de recherche en infectiologie, 2705,, Boulevard Laurier, S-745

Sponsors

Lead Sponsor

Novartis

Collaborators (1)

Novartis Vaccines
All Listed Sponsors
collaborator

Novartis Vaccines

INDUSTRY

lead

Novartis

INDUSTRY

NCT01446289 - Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings | Biotech Hunter | Biotech Hunter