Drugs / GBS6
last change Sep 2025 re-read 3 minutes ago

GBS6

Vaccine

Developed for
group B streptococcal infection
Investigated by
Pfizer

Trials 2

20192020202120222023202420252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 22 trials
Phase 2 NCT04258995 Feb → Sep 2020 group B streptococcal infection Pfizer Completed No outcome recorded
Phase 2 NCT03765073 Jan 2019 → Mar 2024 group B streptococcal infection Pfizer Completed No outcome recorded
Comparator or background therapy1 trial
Phase 2 NCT05832502 Comparator Oct 2022 → Sep 2025 group B streptococcal infection St George's, University of London Unknown No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2023-07-19 Pfizer Results Pfizer Announces New England Journal of Medicine Publication on Group B Streptococcus (GBS) Maternal Vaccine Candidate pfizer.com ↗
Results from an ongoing Phase 2 study in pregnant individuals showed the investigational vaccine, GBS6, was generally well-tolerated and generated robust maternal antibody responses that were efficiently transferred to infants
2022-09-07 Pfizer Regulatory FDA Grants Breakthrough Therapy Designation to Pfizer’s Group B Streptococcus Vaccine Candidate to Help Prevent Infection in Infants Via Immunization of Pregnant Women pfizer.com ↗

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 3 sources stand behind the page.

FieldValueCited text
Known as GBS6 “A hexavalent CPS-cross-reactive material 197 glycoconjugate vaccine (GBS6) is being developed as a maternal vaccine to prevent invasive group B streptococcus in young infants.” PMID 37467497 ↗ Jul 2023
2

“The investigational products are GBS6 and placebo (saline control).” NCT05832502 ↗

NCT04258995 ↗

Modality Vaccine “hexavalent CPS-cross-reactive material 197 glycoconjugate vaccine” PMID 37467497 ↗ Jul 2023
Route Intramuscular “GBS6 administered intramuscularly by injecting 0.5 mL into the deltoid muscle” NCT05832502 ↗