NCT05154578View on ClinicalTrials.gov

Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women

PHASE2CompletedINTERVENTIONAL
Enrollment

269

Participants

Timeline

Start Date

February 17, 2022

Primary Completion Date

April 26, 2023

Study Completion Date

October 18, 2023

Conditions
Group B Streptococcal Infection
Interventions
BIOLOGICAL

GBS-NN/NN2 Vaccine

0.5 mL GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS-NN2 and 0.5 mg of aluminium, given by intramuscular injection.

BIOLOGICAL

Placebo

0.5 mL normal saline given by intramuscular injection

Trial Locations (10)

Unknown

Aarhus University Hospital; Skejby, Aarhus

Hvidovre University Hospital, Hvidovre

Institut for Regional Sundhedsforskning, Kolding

ESRU Rahima Moosa Mother and Child Hospital, Johannesburg

Shandukani Research Clinic, Johannesburg

Wits Vaccines & Infectious Diseases Analytics, Johannesburg

Mecru Clinical Research Unit (MeCRU), Pretoria

Setshaba Research Centre, Pretoria

St George's University Hospital, London

University Hospital Southampton, Southampton

Sponsors

Lead Sponsor

Minervax ApS
All Listed Sponsors
collaborator

Larix A/S

INDUSTRY

lead

Minervax ApS

OTHER

NCT05154578 - Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women | Biotech Hunter | Biotech Hunter