Who is sponsoring NCT04596878?

NCT04596878 is sponsored by Minervax ApS.

What condition does NCT04596878 study?

NCT04596878 studies Group B Streptococcal Infection.

What drugs are being tested in NCT04596878?

Interventions: GBS-NN/NN2, Placebo.

What is the status of NCT04596878?

NCT04596878 is currently COMPLETED.

Last reviewed 2023-08-23 · How we verify

Study of a Group B Streptococcus Vaccine in Pregnant Women Living With HIV and in Pregnant Women Who do Not Have HIV

NCT04596878 PHASE2 COMPLETED

A randomised, placebo-controlled, double-blind study to evaluate the safety, tolerability and immunogenicity of the GBS-NN/NN2 (Recombinant protein vaccine against Group B Streptococcus) vaccine in women living with HIV and women without HIV,and their newborn babies from vaccination up to delivery/birth. Mothers and babies will be followed up for 6 months post-delivery.

Details

Lead sponsor	Minervax ApS
Phase	PHASE2
Status	COMPLETED
Enrolment	205
Start date	Thu Nov 19 2020 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Thu May 11 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Group B Streptococcal Infection

Interventions

GBS-NN/NN2
Placebo

Countries

South Africa, Uganda