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NOT YET RECRUITING
NCT07492706
PHASE1

Safety, Tolerability and Immunogenicity of a Maternal Respiratory Syncytial Virus (RSV) Vaccine (MKK900) in Healthy Adult Women

Sponsor: MAXVAX Biotechnology Limited Liability Company

View on ClinicalTrials.gov

Summary

A Phase 1 study to evaluate safety, tolerability and immunogenicity a RSV vaccine in healthy women 18 to 49 years of age

Official title: A Phase 1, Randomized, Blinded, Active Controlled Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of a Recombinant, Stabilized Pre-F Respiratory Syncytial Virus (RSV) Vaccine (MKK900), Non-adjuvanted, in Healthy Women Aged 18-49 Years

Key Details

Gender

FEMALE

Age Range

18 Years - 49 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-04-01

Completion Date

2027-01-15

Last Updated

2026-03-25

Healthy Volunteers

Yes

Interventions

BIOLOGICAL

MKK900 60 µg

Unit Dose Strength: The 60-μg dose vial will have a concentration of 120 μg/mL (0.5 mL injection volume) Route of Administration : Intramuscular Injection

BIOLOGICAL

MKK900 120 µg

Unit Dose Strength: The 120-μg dose vial will have a concentration of 240 μg/mL (0.5 mL injection volume). Route of Administration : Intramuscular Injection

BIOLOGICAL

ABRYSVO®

Dose Formulation: Vial of Lyophilized Antigen Component (sterile white power) that is reconstituted at the time of use with a Sterile Water Diluent Component. Unit Dose Strength: 120 µg of RSV stabilized pre-fusion F proteins (60 µg RSV pre-F A and 60 µg RSV pre-F B) per 0.5 mL. Route of Administration: Intramuscular injection

Locations (2)

Emeritus Research Sydney

Botany, New South Wales, Australia

Emeritus Research Camberwell

Camberwell, Victoria, Australia