A Multicentre, Parallel-Group, Observer-Blind, Randomised, Placebo-Controlled, Pivotal Trial Investigating the Safety and Immunogenicity of Group B Streptococcus Vaccine (GBS-NN/NN2) in Pregnant Women and Infants Born to Pregnant Women Vaccinated During Pregnancy

Status

Not yet recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2026-525385-21-00

Enrollment

138

Registered

2026-09-18

Start date

Unknown

Completion date

Unknown

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of Group B streptoccoccus infection

Brief summary

Phase 2: • Functional antibody titres, determined at birth., Phase 3: • Infant participants with functional antibody titres reaching predefined iGBS EoD protective thresholds at birth, Phase 3: • Infant participants with functional antibody titres reaching predefined iGBS LoD protective thresholds at birth.

Interventions

DRUG0.9% sodium chloride

DRUGGBS-NN/NN2

Eligibility

Sex/Gender

All

Age

0 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Phase 2: • Functional antibody titres, determined at birth., Phase 3: • Infant participants with functional antibody titres reaching predefined iGBS EoD protective thresholds at birth, Phase 3: • Infant participants with functional antibody titres reaching predefined iGBS LoD protective thresholds at birth.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Sep 19, 2026