NCT06494475

GBS-NN/NN2 (50 µg of Each Fusion Protein [GBS-NN and GBS-NN2] in Combination With 500 µg Aluminum as Alhydrogel®) Given With and Without the Tdap Vaccine in Healthy Non-pregnant Women 18 to 49 Years of Age

A Randomised, Observer-Blind Trial to Evaluate the Immunogenicity, Safety, and Reactogenicity of a Group B Streptococcus Vaccine (GBS-NN/NN2) When 1 Dose is Administered Concomitantly With the Tdap Vaccine in Healthy-non Pregnant Women 18 to 49 Years of Age Compared to When Each Vaccine is Administered Alone

• Status: Not Yet Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 564 (estimated)
• Sponsor: Minervax ApS · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

The main objectives of the study are to demonstrate the non-inferiority of the immune response induced by co administered GBS-NN/NN2 and tetanus, diphtheria, and acellular pertussis (Tdap) compared to the separate administration of GBS-NN/NN2 and Tdap, to evaluate the reactogenicity of GBS NN/NN2 when administered alone or in combination with Tdap, and to evaluate the safety of GBS-NN/NN2 when administered alone or in combination with Tdap in terms of serious adverse events (SAEs) and unsolicited adverse events (AEs).

Conditions

• Streptococcus Agalactiae Infection

Interventions

Type	Name	Description
DRUG	GBS-NN/NN2 vaccine	Intramuscular injection.
DRUG	Tdap vaccine	Intramuscular injection.
DRUG	Placebo	Intramuscular injection.

Timeline

• Start date: 2024-12-17
• Primary completion: 2025-06-21
• Completion: 2025-06-21
• First posted: 2024-07-10
• Last updated: 2024-07-10

Regulatory

• FDA-regulated drug study