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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

NCT06494475 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 564

Last updated 2024-07-10

No results posted yet for this study

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

DRUG

GBS-NN/NN2 vaccine

Intramuscular injection.

DRUG

Tdap vaccine

Intramuscular injection.

DRUG

Placebo

Intramuscular injection.

Sponsors & Collaborators

  • Minervax ApS

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2025-06-21
Completion
2025-06-21
FDA Drug
Yes

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Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06494475 on ClinicalTrials.gov